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IRON, According to a study published in Immunological COVID-19 Research, in addition to hyperglycemia, an alteration of iron metabolism also occurs in severe cases of AND COVID-19 (Perricone, C., et al. 2020). As per some MUCORMYCOSIS experts, severe COVID-19 can be interpreted also as a ‘Hyper-Ferritinemic Syndrome’. High ferritin levels lead to excess intracellular iron that generates Reactive Oxygen Species resulting in tissue damage. Cytokines, especially IL-6, generated by the severe state of infection and diabetic ketoacidosis, can trigger ferritin synthesis and down-regulate iron export. The resultant tissue damage leads to the release of free iron into circulation. This iron overload and the presence of excess free iron seen in academic states can function as one of the predisposing factors for mucormycosis. diabetes mellitus (particularly in the ingestion of the spores. Though this kind eyelid drooping, proptosis, external and presence of ketoacidosis), malignancy of mucormycosis is with high mortality internal ophthalmoplegia, visual loss, (such as lymphoma and leukemia), rate (85%), it is rarely reported in an and blackish necrosis of palate and renal failure, AIDS, extensive burn, immune-competent patient. nasal mucosa. The disease chronic sinusitis or having advanced usually initiates on the nasal and oral rheumatologic disorders. Persons who The symptoms of gastro-intestinal mucosa and then spreads to paranasal have done organ transplantation and mucormycosis may include fever, sinuses. taking immunosuppressive agents are at nausea, abdominal pain, gastro- the high risk group. intestinal bleeding, and perforation. It propagates into the orbital space The endoscopic appearance of through the lamina papyracea. Vision Rhino-orbito-cerebral gastric mucormycosis is usually a loss is caused by the involvement of mucormycosis large ulcer with necrosis, eventually optic nerve or retinal supplying vessels. presenting an adherent, thick, green The intracranial space can be involved If the leukocytes have less efficacy on exudate. Diagnosis is confirmed by directly through the orbital orifices and destroying the fungal spores, the fungal histopathologic identification based on sinus walls, or through the bloodstream. hyphae will proliferate and invade the the biopsy of the suspected area during Cavernous sinus thrombosis can occur vessel walls of the infected region of surgery or endoscopy. as a complication which results in the the human body. This could result in damage of the cranial nerves. thrombosis, ischemia and necrosis. The Chances of co-infections infection can spread into the paranasal Problem with the symptoms sinuses and from there it can spread According to studies among COVID-19 into the orbital and intracranial spaces. patients, mucormycosis can be a As per a dossier published by Centres This can happen either directly or result of fungal super-imposition or for Disease Control and Prevention through the bloodstream, resulting in coinfection. As per the researchers, T (CDC), symptoms of certain fungal a pathologic condition called rhino- lymphocytes (CD4 and CD8) are found diseases can be similar to those of orbito-cerebral mucormycosis which to be low in severe COVID-19 and the COVID-19. These include fever, cough, is the most common type of human levels of IL-2 R, IL-6, IL-10, and TNF-α and shortness of breath. Some patients mucormycosis. are markedly high. However, as part may be having COVID-19 and a fungal of a case report submitted to the infection at the same time. However, Other common forms European Journal of Ophthalmology, 24 according to the CDC, people with November 2020, COVID-19 has never severe COVID-19, such as those in an Other forms of mucormycosis also exist, been reported as a predisposing factor intensive care unit (ICU), are particularly but they are not as common as rhino- for rhino-orbital and/or rhino-orbito- vulnerable to fungal infections such as orbito-cerebral mucormycosis. These cerebral mucormycosis. Aspergillosis or invasive Candidiasis. include the cutaneous, pulmonary, These fungal co-infections can be gastrointestinal, and disseminated Symptoms associated with severe illness form of mucormycosis. Though not a and death. common occurrence, mucormycosis of The symptoms of rhino-orbito-cerebral the gastrointestinal tract can mucormycosis include facial pain — with inputs from N S Arunkumar and also occur as a result of the and paresthesia, headache, periorbital Agencies and nasal swelling, inflammation, 52 / FUTURE MEDICINE / June 2021

UPCODVAIDT-19ES

covid-19 udpates VLWAAOCURCNLICDNH’ESEBFDOIRIONSSTUTKECROVSITDU-1D9Y Anew, government-funded It will give scientists from around taken to measure their immune clinical trial looking at different the globe and the experts behind responses at days 28, 84, 308 and COVID-19 ‘booster’ vaccines has the UK’s COVID-19 vaccination 365, with a small number having been launched in the UK. programme a better idea of the impact additional blood tests at other times. of a booster dose of each vaccine in All the sites will have an electronic Matt Hancock, UK’s Health protecting individuals from the virus. diary for all participants that will Secretary, announced that thousands send alerts to the team in of volunteers will receive a booster The study will take place at 16 real-time if needed and a 24-hour COVID-19 vaccine in a new clinical trial. National Institute for Health Research emergency phone to a doctor on the (NIHR)-supported sites across England, study, who can provide further clinical The Cov-Boost study, led by and also within Health and Care advice. University Hospital Southampton NHS Research Wales and NHS Research Foundation Trust and backed by £19.3 Scotland sites. It will include a total of The initial findings, expected in million of government funding through 2,886 patients and the participants are September, will help inform decisions the Vaccines Taskforce, will trial seven to start getting vaccinated in May. by Joint Committee on Vaccination vaccines and will be the first in the and Immunisation (JCVI) on plans for world to provide vital data on the All participants will be monitored a booster programme from autumn impact of a third dose on patients’ throughout the study for any side this year, ensuring the country’s most immune responses. effects and will have blood samples UK MHRA extends storage conditions for Pfizer vaccine from 5 to 31 days The UK Medicines and Healthcare stability data submitted to the regulator products Regulatory Agency (MHRA) by Pfizer. has approved new storage conditions for the Pfizer/BioNTech COVID-19 Dr June Raine, MHRA Chief vaccine, which extend the length of Executive, said: We are pleased to time the thawed vaccine can be stored confirm that, having rigorously assessed at normal fridge temperatures from 5 the additional data submitted to us by days to 31 days. the company, we have now approved more flexible storage conditions for the The Pfizer/BioNTech vaccine, which Pfizer/BioNTech vaccine. was the first COVID-19 vaccine to be approved by the UK regulator, must be Up until now, the Pfizer vaccine stored at ultra-low temperatures until had to be administered within 5 days use. The changes, that extend the shelf- of being removed from ultra-low life once thawed, are therefore expected temperature freezers. to make storage easier and possible for a wider range of health facilities. Now that the jab can be stored at normal fridge temperatures for up to The change was approved following 31 days, it can be used in a wider range the MHRA’s detailed review of additional of healthcare settings, giving patients greater access to the Pfizer vaccine. 54 / FUTURE MEDICINE / June 2021

vulnerable are given the strongest Vaccine Taskforce, with the possible protection over the winter study being undertaken period. by the Southampton team at sites across The trial will look at seven different the UK as part of the COVID-19 vaccines as potential National Immunisation boosters, given at least 10 to 12 Schedule Evaluation weeks after a second dose as part of Consortium (NISEC). the ongoing vaccination programme. One booster will be provided to each Bharat Bio volunteer and could be a different boosts brand to the one they were originally Covaxin vaccinated with. production Vaccines being trialled include Bharat Biotech is planning Oxford/AstraZeneca, Pfizer/BioNTech, to ramp up additional Moderna, Novavax, Valneva, Janssen manufacturing capacities for and Curevac, as well as a control Covaxin by 200 million doses group. The trial has received ethics at Chiron Behring Vaccines, approval by the NHS Research Ethics Ankleshwar Gujarat, a wholly- Committee, as well as approval from owned subsidiary of Bharat the MHRA. Biotech. Participants will be adults aged The company plans to 30 years or older as these will have produce 200 million doses been those immunised early on in the of Covaxin per annum in vaccination programme - for example, the good manufacturing adults aged 75 and over or health and practice (GMP) facilities that care workers. are already operational for the production of vaccines The trial was commissioned by based on Inactivated Vero Cell the Department of Health and Social Platform Technology, under Care through NIHR and funded by the stringent levels of GMP and biosafety. Product availability at Ankleshwar will commence from Q4 2021. Bharat Biotech had already deployed multiple production lines at its Hyderabad & Bengaluru campuses, adding Chiron Behring to this line-up of high containment BSL rated GMP facilities that are required to manufacture Covaxin. This effectively takes the volumes upto ~ 1 billion doses per annum, with its own established campuses specialised for manufacturing inactivated viral vaccines under the highest levels of biosafety. June 2021 / FUTURE MEDICINE / 55

THE HUNT FOR A VACCINE Researchers around the world are working at a breakneck pace to test different types of vaccines to stop COVID-19. PHASE 151 34 30 7 8 PHASE 2 PHASE 3vaccinesvaccines invaccines invaccines Vaccines LIMITED USEtesting safetyexpandedlarge-scaleapproved forapproved APPROVEDand dosagesafety trialsefficacyearly orfor use tests ltd use Medicago, GSK announce interim phase 2 data on plant-derived candidate Medicago and GlaxoSmithKline (GSK) received Fast Track designation by the recombinant COVID-19 plant-derived reported positive interim phase 2 US FDA and Health Canada has initiated vaccine candidate in subjects aged clinical trial safety and immunogenicity a review of Medicago’s COVID-19 rolling 18 and above. It was conducted in data for Medicago’s plant-derived submission under the Interim Order. multiple sites in Canada and the US COVID-19 vaccine candidate, which has in a population composed of healthy been tested in combination with GSK’s The phase 2/3 study is a multi- adults (18-64y), elderly adults (over pandemic adjuvant. portion design to confirm that the 65y) and adults with comorbidities. chosen formulation and dosing regimen Each age group enrolled up to 306 These results are part of the of CoVLP (two doses of 3.75 µg CoVLP subjects randomized 5:1 to receive the ongoing phase 2/3 study and reiterate combined with GSK’s pandemic adjuvanted CoVLP vaccine candidate: the promising profile observed during adjuvant given 21 days apart) has an placebo and with 2:1 stratification phase 1 testing. Immunogenicity, as acceptable immunogenicity and safety in older adults (65-74 and =75). All measured by the neutralising antibody profile in healthy adults 18-64 years of subjects will be followed for a period of titre, was high: about 10 times higher age, elderly subjects aged 65 and over 12 months after the last vaccination for than those in a panel of sera from and adults with comorbidities. the assessment of safety and durability patients recovering from COVID-19. of the immune responses to the vaccine No related severe adverse events The phase 2 portion of the trial was candidate which will be the final were reported and reactogenicity was a randomized, observer-blind, placebo- analysis. generally mild to moderate and short in controlled study to evaluate the safety duration. and immunogenicity of the adjuvanted The interim data from phase 2 in adults and in the elderly show safety and tolerability results, and immunogenicity, as measured by neutralizing antibody (NAb) and cell- mediated immunity (IFN and IL-4 ELISpot) responses, in adults aged 18- 64 (adults) and older adults aged 65+ (older adults). Medicago’s vaccine candidate with GSK’s pandemic adjuvant induced a significant humoral immune response of similar strength in both age cohorts after two doses. The phase 3 trial of the vaccine candidate was launched on 16 March 2021. Trial sites are currently enrolling subjects in Canada, US, UK and Brazil, with additional sites expected to be added. The vaccine candidate has 56 / FUTURE MEDICINE / June 2021

EMA COMMITTEE ISSUES POSITIVE OPINION ON GSK & VIR’S SOTROVIMAB CureVac’s 2nd gen GlaxoSmithKline plc and Vir ICE (COVID-19 Monoclonal antibody vaccine shows high Biotechnology, Inc announced Efficacy Trial - Intent to Care Early) immunogenicity in that the European Medicines trial, which evaluated sotrovimab as preclinical study Agency’s (EMA) Committee for Human monotherapy for the early treatment Medicinal Products (CHMP) has issued of COVID-19 in adults at high risk CureVac announced, together with a positive scientific opinion following of hospitalisation. Efficacy results its collaboration partner GSK, first the referral of sotrovimab to the of the interim analysis, based on preclinical data in a rat model, showing CHMP under Article 5(3) of Regulation data from 583 randomised patients, that its second-generation COVID-19 726/2004. demonstrated an 85% (p=0.002) vaccine candidate, CV2CoV, induces high reduction in hospitalisation or levels of antigen production as well as The opinion relates to the use death in those receiving sotrovimab strong and dose-dependent immune of sotrovimab for the treatment of compared to placebo, the primary responses in vaccinated animals. adults and adolescents (aged 12 endpoint of the trial. As a result, years and over and weighing at least the Independent Data Monitoring CV2CoV is a co-development 40 kg) with COVID-19 who do not Committee recommended that the between CureVac and GSK and is based require oxygen supplementation and trial be stopped for enrolment due on a new mRNA backbone which differs who are at risk of progressing to to evidence of profound efficacy. The from CureVac’s first-generation vaccine severe disease. CHMP also considered data on the candidate, CVnCoV, currently in late- medicine’s quality and safety. stage clinical testing. The CHMP opinion under Article 5(3) can now be considered by the The CHMP also reviewed data Preclinical data in rats immunized national authorities in EU member from several in vitro studies which with CV2CoV in the dose range of 0.5- states when taking evidence- demonstrated that sotrovimab 40µg demonstrated the fast onset of based decisions on the early use maintains activity against multiple strong immune responses already after of the medicine prior to marketing circulating variants of concern, the first dose. In addition, the serum of authorisation. including the variants from Brazil (P.1), vaccinated animals showed significant California (B.1.427/B.1.429), South cross-neutralization against variants first The CHMP reached its opinion Africa (B.1.351) and the UK (B.1.1.7), discovered in Denmark (B.1.1.298), the following a review of data including based on in vitro data from live virus UK (B.1.1.7) and South Africa (B.1.351). an interim analysis of efficacy and The full manuscript of the preclinical safety data from the phase 3 COMET- data is available on the preprint server bioRxiv. CV2CoV is based on a new mRNA technology that features targeted optimizations designed to improve intracellular mRNA stability and translation for increased and extended protein expression. These optimizations potentially allow for strong immune responses at low doses, which will support the development of multivalent vaccines to target rapidly spreading COVID-19 variants. First clinical trials for CV2CoV are expected to start in the third quarter of 2021. June 2021 / FUTURE MEDICINE / 57

and pseudotyped virus assays. Additional Optimus to begin phase-3 in vitro data demonstrating activity against trial of molnupiravir in India variants from New York (B.1.526) and India (B.1.617) were also recently published by Optimus Pharma said it has versus standalone standard bioRxiv. The clinical impact of these variants received the Drug Controller supportive care. is not yet known. Sotrovimab targets a General of India’s (DCGI) approval conserved epitope of the spike protein for conducting phase-III clinical The treatment duration is a which is less likely to mutate over time. Data trials for orally administered maximum of 5 days and the total collection and analysis are still ongoing. molnupiravir capsules on mild to study duration will be a maximum moderate COVID-19 patients. of 29 days from randomisation, the The multi-centre, double-blind, release said. placebo-controlled, phase 3 COMET-ICE trial Optimus Pharma said it has investigated intravenous (IV) infusion of internally developed the active Molnupiravir demonstrated sotrovimab in adults with mild or moderate pharmaceutical ingredient (API) highly promising results in reducing COVID-19 at high risk of progression to and the formulations for the viral load to almost zero in merely 5 severe disease. product it had filed for clinical trials days of treatment duration. with the DCGI. This ongoing trial evaluated the safety Based on completed phase-2 and efficacy of a single IV infusion of As per the clinical trial protocol part clinical studies, the proposed sotrovimab (500 mg) or placebo in non- approved, as many as 2,500 dosage is 800 mg twice daily which hospitalized participants globally. The safety subjects with mild to moderate significantly reduces viral culture in of sotrovimab is primarily based on an COVID-19 will be randomised in the infected patients not progressing interim analysis from 868 patients (430 study in a 1:1 ratio to molnupiravir into acute respiratory distress patients in the treatment arm and 438 in with standard supportive care syndrome. the placebo arm) through Day 29. Among those studied, 63% were Hispanic or Latino 2,500 subjects with mild to moderate and 7% were Black or African American. COVID-19 will be randomised According to the US Centers for Disease in the study in a 1:1 ratio to Control and Prevention, these populations molnupiravir with standard are approximately three times more likely to supportive care be hospitalized and approximately two times more likely to die of COVID-19. The primary efficacy endpoint was the proportion of patients who have progression of COVID-19 as defined by the need for hospitalisation for at least 24 hours or death within 29 days of randomisation. The only event to occur with a frequency of greater than 1% in the sotrovimab arm was diarrhoea (less than 1% in the placebo group). All other adverse events with a frequency of greater than 1% occurred in the placebo arm. No other treatment- emergent adverse events were reported at a higher rate with sotrovimab compared to placebo. Sotrovimab’s safety and efficacy is continuing to be studied in ongoing clinical trials with analysis of safety and efficacy data at Day 29 for the full population from COMET-ICE expected as early as the first half of 2021. Sotrovimab is an investigational SARS- CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. 58 / FUTURE MEDICINE / June 2021

Human-derived antibody shows efficacy against variants: Memo Memo Therapeutics AG derived from recovered said that MTX-COVAB, patient samples. This its human-derived antibody approach has enabled against SARS-CoV-2, has the company to also shown efficacy against identify a very promising both the original virus as antibody candidate against well as the UK variant the South African variant (B.1.1.7). (B.1.351). Memo is now preparing Memo is collaborating MTX-COVAB for clinical with Serum Institute India and evaluation. academic partners in Austria, Brazil and South Africa to Using its microfluidic, source patient samples in single-cell molecular cloning the coming weeks to enable and screening technologies the isolation of promising, to enable antibody repertoire effective antibodies against mining and antibody each of the variants. This can discovery, Memo can be achieved in as little as discover novel antibodies 3 weeks from receiving the at unprecedented speed, blood sample. efficiency and sensitivity Roche launches casirivimab BDR Pharma to speed up & imdevimab in India production of baricitinib Roche India and Cipla Limited announced that the BDR Pharma said it has entered into a royalty- first batch of the antibody cocktail (casirivimab and free, limited and non-exclusive voluntary licensing imdevimab) is available in India while a second batch will agreement with Eli Lilly and Company for the be made available by mid-June. manufacturing and distribution of baricitinib for the treatment of COVID-19 in India. In total, they can potentially benefit 200,000 Baricitinib received restricted emergency use patients as each of the approval, for use in combination with remdesivir, for 100,000 packs that will treatment of suspected or laboratory-confirmed COVID-19 be available in India in hospitalized adults and paediatric patients 2 years of offers treatment for two age or older, requiring supplemental oxygen, invasive patients. mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Lilly received permission for Cipla will distribute restricted emergency use from Central Drugs Standard the product by leveraging Control Organization. its strong distribution strengths across the country. This collaboration between BDR and Lilly will increase The drug will be available through leading hospitals and the availability of baricitinib in India, enhancing local COVID treatment centres. The Central Drugs Standards treatment choices. Control Organisation (CDSCO) had recently provided an Emergency Use Authorisation (EUA) for the antibody Baricitinib is an oral medication currently registered cocktail casirivimab and imdevimab in India. It has also in India for the treatment of moderate to severe active received a EUA in the US and several EU countries. rheumatoid arthritis. Casirivimab and imdevimab is to be administered June 2021 / FUTURE MEDICINE / 59 for the treatment of mild to moderate COVID-19 in adults and paediatric patients (12 years of age or older, weighing at least 40 kg) who are confirmed to be infected with SARS-CoV-2 and who are at high risk* of developing severe COVID-19 disease.

CCMB SCIENTISTS SAY 4 DIFFERENT SVAPRREIAANDTINSGOFACSRAORSSS-CINOVD-IA2 Scientists from Centre for Cellular and CCMB scientists, it is understood that northern Molecular Biology (CCMB) in Hyderabad, as parts of India, such as Delhi, Haryana, Uttar part of their research of genome sequencing Pradesh and Punjab, are witnessing the UK of the prevailing SARS-CoV-2, have identified that variant of SARS-CoV-2. Apart from this, the there are 4 major variants of coronaviruses that B1.617 variant is also spreading fast. In are spreading widely in different parts of India. Maharashtra, the state which is witnessing the highest number of COVID-19 cases in the country, Reports quoting Dr Rakesh Mishra, director the spread is said to have been due to a double of CCMB, said the main reason for coronavirus to mutant and a triple mutant variant of the virus. spread widely in India during the second wave is The B1.617-1,2,3 variants of the viruses are its different variants. If the virus is of a singular prevailing in this region. variant having no mutations, its spread can be curtailed by breaking its infection chain. However, In the Maharashtra state, apart from the CCMB identified 4 different mutant variants of the double mutant variant, about 10 percent of the coronavirus spreading widely in different parts of cases are also found to have the triple mutant. India. This triple mutant variant of the virus is the most infectious and is the main reason for the According to him, North India has one type widespread nature of the disease, observed the of COVID-19 virus, which is completely different CCMB scientists. from the one spreading in the South. Similarly, the western parts of Maharashtra, Gujarat and In the Eastern parts of India, including West Rajasthan have another type of coronavirus, while Bengal, Manipur and other regions, the scientists the areas of West Bengal and other Eastern parts found the B1.618 variant virus. More than 20 of the country are witnessing the spreading of a percent of the cases are found to have been different mutant variant of the deadly virus. infected by this kind of coronavirus variant in the region. Unlike in the first wave of the COVID-19 disease that spread last year, which had only one or two Coming to the southern parts, states like Telangana, Andhra Pradesh, Kerala, Karnataka mutant variants, this time the main reason for and Tamil Nadu, the N440K variant of the virus the record spike in COVID-19 cases in India is said to be widely prevalent. The UK variant, is the high number of variants of the double mutant and N440K are the most infectious coronavirus. variants, according to the scientists. As per the study by the 60 / FUTURE MEDICINE / June 2021

Mylab to launch self-use US FDA grants COVID-19 test kit in India EUA to Pixel home test kit Mylab Discovery Solutions The kit comes with an for ages 2-17 announced that it has instruction kit, a nasal swab, a The US FDA has granted received the Indian Council of pre-filled extraction tube, a test Medical Research’s (ICMR) card and a biohazard bag. Unlike Emergency Use Authorization approval for CoviSelf, the country’s a nasopharyngeal swab used in an (EUA) for Pixel by Labcorp first self-use rapid antigen test for RT-PCR test that has to be inserted COVID-19 PCR Test Home COVID-19. deep into the cavity, a nasal swab Collection Kit for ages 2-17. reduces the discomfort as it has to The approval followed an be inserted only 2-4 cm into each The authorization expands advisory by the apex biomedical nasal cavity. the use of Pixel to children and research agency allowing the adolescents 2 years of age and use of self-testing kits even as it A user has to install the older when purchased by a cautioned against its indiscriminate ‘Mylab Coviself’ app to fill in parent or guardian. use. credentials and then proceed with the test by inserting the Pixel uses the same PCR test The test can be purchased swab into both nasal cavities trusted by doctors and hospitals for ₹250 without a prescription to collect the sample across the country. Individuals from local pharmacies and online and then conduct the aged 14-17 can self-collect with channel partners, the Pune-based test according to the adult supervision, and children company said in a statement. instruction manual. A between the ages of 2 and 13 result will be available in will need adult assistance to Testing will be monitored 15 minutes. collect their sample. using Mylab’s mobile phone application, through which users A positive result Parents and guardians can are advised to click a picture of is indicated by the request a kit for children 2 the test strip after completing the appearance of a line at years of age and older directly procedure. the “T” test line as well as through www.pixel.labcorp.com. the “C” control line, while Once the request is received by The test kits will be sold negative results only have Labcorp, a kit will be shipped to through chemists across India. a “C” line. To make readings the individual’s home via FedEx. Mylab is also in discussions with easier, the user can click a For adults 18 and over, the e-commerce and e-pharmacy picture of the test result on the Pixel by Labcorp COVID-19 PCR websites for the distribution of the app. Test Home Collection Kit is also kits while making sure it complies available in pharmacies. with existing regulations. June 2021 / FUTURE MEDICINE / 61

column from the industry Need for respiratory distress rehabilitation A rehabilitative care programme acts as the bridge between the hospital and the home RAJINISH MENON For a significant proportion of people, Occupational and Respiratory therapy. COVID-19 leads to medium- to long-term Physiotherapy is carried out in three The author is effects that can have a significant impact Founder & CEO, on the quality of life. Some symptoms may phases. Phase 1 comprises diaphragmatic Sukino Healthcare linger or recur for days, weeks or months breathing exercises to encourage oxygen following initial recovery, while some patients exchange, slow down heartbeats and develop medical complications that may have stabilize blood pressure. Thoracic expansion lasting lifetime health effects. Recovery time is exercises to help loosen secretions from the different for everyone. lungs. Thoracic mobilization exercises clear secretions from the lungs. The teaching of Short-term effects include fatigue, cough, relaxed positions ease breathlessness. All the cold, congestion, shortness of breath, loss of above exercises are done at the patient’s taste/smell, headache, body ache, nausea, bedside. In phase 2, the focus is on strength chest pain, abdominal pain and confusion. and endurance training to improve exercise Prolonged and persistent symptoms due tolerance using dumbbells and Thera bands, to disruption in body systems and affected activities on the stepper, staircase training, organs is also something that recovered hurdle training and bicycle ergometer without patients have faced over time. Long term resistance for the initial days and resistance impact including damage to heart muscle, added as the patient regains efficacy. In Phase heart failure, lung tissue damage, restrictive 3 which is also known as the maintenance lung failure, anosmia, pulmonary embolism, phase, the patient is given enough education stroke, cognitive impairment, anxiety, to carry on the exercises with the list of dos depression, PTSD, sleep disturbances, muscle/ and don’ts at home. joint pain, chronic fatigue, breathlessness and chest pain can severely impact a patient’s Occupational therapy teaches patients future if not treated properly. how to conserve their energy and avoid fatigue through certain adaptive postures Often, such COVID-19 patients need a while performing daily activities. This is level of medical care and rehabilitation that specific to each patient. These include, for is difficult to achieve at home. Some of them instance, taking adequate breaks while using need continuous monitoring and non-invasive the stairs, tying a shoelace in a sitting position clinical intervention supervised by a medical rather than bending, and so on. expert even after they have recovered. This is possible with a comprehensive and planned Respiratory therapy makes use of devices post -COVID-19 rehabilitative program. like Acapella and Flutter, which play a major role in lung secretion clearance. Resistance Once the patient is admitted, a detailed training with the help of power breaths, assessment is carried out by the doctors. incentive spirometry, respiratory muscle Physio, Occupational and Respiratory training are among the few exercises that therapists map out the therapy sessions and help the patient recover and restore their fine-tune a goal-oriented treatment plan respiratory health in the most optimal manner. depending on the condition of the patient. Over the course of the treatment, the progress Optimal care is crucial for the speedy of the patient is assessed on a weekly basis recovery and early return to normal life at with the Borg Dyspnea Scale, the six-minute home after discharge from the hospital. A walk test, the 12-minute walk test, the TUG rehabilitative care programme delivers scale and the Cough Sputum Score. The out-of-hospital care that enables patients treatment is an amalgamation of Physio, to achieve optimal recovery in a best suited environment. 62 / FUTURE MEDICINE / June 2021

hospital news Fortis and Apollo Clinics to provide Healthspring healthcare to Runwal residents opens clinics for walk-in Runwal Group, a real estate brand, has pulse oximeter, BP apparatus, first-aid kit patients tied up with Fortis Hospitals and Apollo and other equipment shall be provided. Clinic to offer healthcare services to the Runwal Group shall also be providing an Healthspring, pioneers residents at their projects. oxygen concentrator facility at the clinic. of primary healthcare In addition, Runwal Group also plans to services, has opened its This will provide the group’s customers provide ambulance services for residents. clinics for walk-in patients with special benefits and privileges. The for non-COVID medical benefits can be availed by a homebuyer Apollo Clinics, a multi-specialty chain emergencies and home care and their nominated family members and of clinics under Apollo Health & Lifestyle services. can be used by multiple homeowners at Limited (AHLL), a subsidiary of Apollo one particular time, subject to availability. Hospitals Enterprise Limited (AHEL), will Every clinic of soon be operational at Runwal Forests in Healthspring is operational Apollo Clinic will offer facilities such Kanjurmarg, Mumbai, providing superior Monday to Saturday between as specialist consultation, diagnostics, healthcare services. 8 am to 5.30 pm and the preventive health checks, blood sample helpline and doctors are collection, homecare services, dentistry, A hospital has been planned within the available in person or via tele diabetes management, physiotherapy, campus of Runwal Gardens also, a 115-acre or video consultation. vaccinations and pharmacy, all under township in Dombivli where the residents one roof. Medical equipment such as can access healthcare assistance. Having serviced over 200 corporates, Healthspring has 25 clinics and is operational across cities through their extended network. Last year, Healthspring expanded its homecare and emergency care services for many senior-citizen patients. Some of the key milestones achieved amidst the pandemic include successfully running 18 operational centres. Amrita sets up COVID resource centre in Faridabad Amrita Institute for Medical locate hospital beds, oxygen, Sciences (Amrita Hospitals) and cylinders, and medications for COVID its parent organization’s youth wing, patients. The second branch of Ayudh Delhi. have set up a resource Amrita Hospitals, with over 2,000 centre in Faridabad, which is helping beds, is already under construction connect patients with medical in Faridabad. treatment and supply options across the country. At the Resource Centre, volunteers are working round the Being conducted under the clock, gathering and verifying the aegis of Swami Nijamritananda needs of the people and available Puri, Head, Mata Amritanandamayi resources. Two ambulances are Ashram, Delhi, the centre helps available free of charge. June 2021 / FUTURE MEDICINE / 63

cardio genetics TAOCCLLAIRNIIOCNIACNASLLFAMILIAL HYPERCHOLESTEROLEMIA Despite its significant impact on the cardiovascular disease burden, familial hypercholesterolemia is underdiagnosed and undertreated globally DR RAMAN PURI & undetected and are responsible for stigmata, family history of premature DR RASHMI NANDA premature coronary artery disease in CAD/ high LDL-C / cutaneous stigmata, India. and genetic testing. Early diagnosis One baby is born with familial is important for the prognosis of the hypercholesterolemia every HeFH is seen when the individual patient and it also has implications for minute. FH is underdiagnosed inherits one mutant gene and is the diagnosis and treatment of family and undertreated globally. Familial characterized by a 3–4-fold higher members (cascade testing) who may hypercholesterolemia (FH) is an LDL-C concentration. Lipid stigmata have inherited the same disorder. inherited condition leading to including corneal arcus and tendon severely elevated serum low density xanthomata can be seen in HeFH Significance of family history lipoprotein cholesterol (LDL-C) that patients, and patients generally leads to premature atherosclerotic develop premature cardiovascular The family history of premature cardiovascular disease (ASCVD) and ischemic heart disease helps to accounts for 2–3% of the cases of THE FAMILY HISTORY OF identify an autosomal dominant mode myocardial infarction in patients aged PREMATURE ISCHEMIC HEART of inheritance. If both parents have less than 60 years. DISEASE HELPS TO IDENTIFY very high LDL-C (>190 mg/dL) and/ AN AUTOSOMAL DOMINANT or history of heart disease before age It is caused by mutations in the MODE OF INHERITANCE 55-65, this may suggest that they both genes of the LDL-R (LDL receptor), have FH and can each pass a mutated Apo B (Apolipoprotein B) or PCSK-9 disease during their forties. The gene to their children. When each (Proprotein convertase subtilisin/kexin patients with HoFH inherit the parent has HeFH, by chance, 1 of 4 type 9) that interfere with clearance of defective/mutant genes from children will have a normal cholesterol LDL-C by the liver. both the parents, they have 4–8- level, 2 of 4 children will have HeFH fold higher LDL-C concentration and 1 of 4 children will have HoFH. The contribution of FH (650–1000 mg/dl) as compared to to premature cardiovascular the general population and they A child or adult with FH requires disease in India is still unknown. develop cutaneous stigmata and lifelong medications under medical The heterozygous familial atherosclerotic cardiovascular disease supervision and lifelong lifestyle hypercholesterolemia (HeFH) during their teens. LDL-C values in intervention. Lipid Association of India phenotype is encountered most HeFH cases are generally between (LAI) has taken the initiative to offer often (1 in 250-500) whilst the 350–550 mg/dl. free genetic studies and free generic rarely encountered homozygous medicines (Statin and Ezetimibe) familial hypercholesterolemia (HoFH) The diagnosis of FH is based on for the poor patient who are registered phenotype has a worse prognosis biochemical values of total cholesterol with LAI (1 in million). Considering the Indian & LDL -C, clinical findings of lipid population of over a 1.32 billion, LAI Recommendations approximately 2.6 million cases of HeFH and 2500 cases of HoFH are • Lipid profile estimation of children to estimated to be present. Most of be done at 2 years of age in those these patients are undiagnosed or with family history of FH, premature ASCVD, and adopted children. • Universal screening of lipids to be 64 / FUTURE MEDICINE / June 2021

carried out at age 20 years or at the time of college admission including estimation of Lp(a) levels. • Genetic testing should be performed wherever feasible. • Look for other ASCVD risk factors and manage them appropriately. • Strict dietary recommendations and lifestyle modifications as advised. • Drug therapy to be started at age 8 years or earlier in individualized cases. • Screen Family members for FH (Cascade screening). • Achieve LDL-C targets as per LAI under medical supervision. OTHFELIBPUIDRSDEN 2500 FH involves two cases of HoFH are phenotypes: the estimated to be present heterozygous familial hypercholesterolemia (HeFH) phenotype and the rare homozygous familial 2.6 millionhypercholesterolemia (HoFH) Indians are estimated to be suffering from HeFH The authors are Senior Interventional Cardiologist and Founder & Chairman, Lipid Association of India, and a Certified Lipidologist by Lipid Association of India respectively June 2021 / FUTURE MEDICINE / 65

accessories SUTCHNEESNACAFHERAIPLOLPOEEFNKGITINSG Lack of knowledge about the quality standards of personal protective equipment among new and inexperienced manufacturers and the absence of mandatory requirements for quality compliance by regulatory agencies leave the users, including healthcare warriors, at a higher risk of infection Personal protective equipment (PPE) pandemic, which continues to remain used in healthcare settings have highly contageous and out of control. gained much importance, public attention and market value worldwide However, as COVID-19 was a new after the outburst of COVID-19. It has pandemic experience even to those in the now become one among the most critical medical field, health workers, including components of infection control and doctors and nurses, often wondered protection protocols for the virus-caused whether the PPEs and practices are sufficient to prevent the new virus from 66 / FUTURE MEDICINE / June 2021

infecting them. Certainly, there have environment and the people. Many healthcare users been reports about rising incidences It was this situation that triggered do not even know that of health workers getting infected the normal spunbond from across the country, despite using some independent as well as fibre that is often found PPEs that were supposedly designed sponsored research on the quality used for body-coveralls specially for COVID-19. Naturally, this standards to be followed for PPEs in is not medical grade and led to general concern and demand for healthcare and their utility. Much of the thus will not guarantee PPEs that followed strict compliance to specifications for PPEs against SARS- any protection from virus specified quality standards. CoV-2 needed redefining. The type of infection. materials used in manufacturing and Despite great concerns in the the details about the quality standards Kora James research field related to the quality of the other accompanying wearables assurance mechanisms for PPEs; were researched. Gradually, the Indian Director, they failed to evoke the due alertness industry and the government began Careon Healthcare Solution from the government. Perhaps, the to establish quality standards and government and the hospitals did innovations in their products to find June 2021 / FUTURE MEDICINE / 67 not have much prior knowledge or suitable, cost-effective solutions for experience in the selection of quality- the people of India striving to fight off assured and suitable PPEs, or any the pandemic. However, there is still idea about the stocks or supply- a lack of stringent guidelines along chains relating to it. Anyway, such with standard operating procedures concerns have had an impact in the regarding PPE issued in most of the market. Globally many manufacturers repurposed their facilities to produce CONCERNS AMONG more PPEs. However, they were still RESEARCHERS ABOUT lacking proper knowledge on the THE QUALITY ASSURANCE design, the materials to be used, and MECHANISMS FOR PPES HAVE the quality standards and regulations FAILED TO TRANSLATE INTO that are to be followed while DUE ALERTNESS ON THE manufacturing PPEs. PART OF THE GOVERNMENT India Scenario hospitals or laboratories or recovery centres all over the country. This India lacked enough organised PPE mainly stems from the lack of proper production before February/March information or efforts to create 2020. The sudden entry of many awareness. unrelated entrepreneurs into the industry made the scenario worse. The Bureau of Indian Standards There was not enough knowledge or (BIS) classifies Surgical Gowns in understanding about PPEs from the 4 levels from Level 0 to 3 under IS part of the companies that turned to 17334:2019. Body-coveralls come PPE production, who had earlier been under IS 17423:2020 based IS 16546- focused on other medical devices or Synthetic Blood Penetration Test even garment making. At the same (Procedure C) which is the same as time, many questions regarding PPEs ISO 16603:2003 Level / Class 3 (3.5 remained unanswered. These ranged kPa). Both fabric and seams are to from basic ones like what PPEs are, be tested. However, BIS demands no what types are most suitable for mandatory test for viral penetration. COVID-19, what ensures or increases The stipulated standard IS 17423:2020 the safety, how they can be made more is lower than standards in USA/Europe, comfortable and cost-effective and so on. The most important question that did not return even an echo as an answer was whether they can be used again and again, and if discarded, what will be the impact on the workforce,

and resistance to viral penetration PPE-MANUFACTURERS mask or a 3 ply surgical mask; gloves under pressure is not yet mandated. SHOULD BE MADE AWARE OF (preferably the nitrile gloves); and the Thus, disposable gowns were often THE QUALITY STANDARDS shoe cover. We mainly make body- used when the patients are known to TO HAVE THEIR PRODUCTS coveralls and shoe covers in-house, be Hepatitis B, C or HIV positive; that TESTED FOR RESISTANCE TO and the rest we source from outside too only in tertiary hospitals where BLOOD- BORNE PATHOGENS/ manufacturers, who comply with operation theatres for specialized VIRAL PENETRATION all quality certifications. There are surgeries exist. However, even there, different standards specified by BIS for reusable gowns made of woven fabrics potentially infectious materials through these products, like the breathable or are still used. These gowns, due to direct/indirect contact of contaminated non-breathable laminated spunbond frequent washing and autoclaving, may body-fluids or with non-intact skin, material or a more comfortable 3 not offer any protection and may get and mucous membranes. Protective layer SMS material for coveralls. easily soaked with liquids or body fluids. clothing or gowns are inevitable for There are similar standards for other healthcare workers to create a barrier components as well,” added James. Healthcare workers must be to eliminate or to reduce contact made aware of these flaws in quality and droplet exposure. In healthcare, However, the major challenge assurance protocols, say serious different grades or types of gowns in India is that most of the players in the industry who emphasize are used according to the purpose, manufacturers, both the new the use of medical grade material for and these are to be made with entrants as well as existing players, foolproof PPE. different material, design and are either not aware of these protective properties. These quality specifications or want to “For instance, many healthcare specifications are solely dependent profiteer by using the cheaper non- users do not even know that the on the level of exposure faced by a standard material in the absence normal spunbond fibre that is often healthcare worker. of a mandatory quality compliance found used for body-coveralls, a key mechanism. component in the PPE kits available “Mainly there are five components in market, is not medical grade and in a PPE kit, which include the coverall The Solution thus will not guarantee any protection suit, which protects the whole body; from virus infection,” said Kora James, the goggles to protect the eyes; N95 Making quality standards mandatory director, Careon Healthcare Solutions, is always the first solution. But in their one of the oldest medical disposables absence, at least the PPE-manufacturers manufacturers in India. should be made aware of the quality standards to have their products Healthcare workers often get tested for resistance to blood-borne exposed to pathogens carried pathogens/viral penetration. These through blood, body-fluids, and other quality standards should be maintained during manufacturing, packaging, storing and transportation. The companies must also include printed notices to be packed along with each PPE product, so that they will automatically create an awareness among the users as well. These notices can include details about product specifications, principles of infection control and good practices for infection control. The users, especially healthcare workers dealing with COVID-19 patients or suspected positive cases, should ensure that the PPEs meet such quality specifications and check them for such label instructions. Finally, the users must also stick to the single-use regime and safe disposal of the same after use. — with inputs from N S Arunkumar 68 / FUTURE MEDICINE / June 2021

devices&gadgets Navitor to treat aortic stenosis receives CE marking Abbott announced it has received valve frame known as paravalvular CE Mark for its latest-generation leak (PVL), a common complication transcatheter aortic valve implantation following TAVI procedures. The new (TAVI) system, Navitor, making the device is the only self-expanding TAVI minimally invasive device available for system with intra-annular (within people in Europe with severe aortic the native valve) leaflets and large stenosis who are at high or extreme frame cells – features designed surgical risk. to help improve access to critical coronary arteries to facilitate future With the Navitor valve, the interventions to treat coronary artery company is advancing TAVI (also disease (CAD). The new design referred to as TAVR, or transcatheter additionally provides improved aortic valve replacement) therapies hemodynamics. with innovations including a unique design to prevent blood leaking The device is implanted with around the valve. Abbott’s FlexNav delivery system, which received CE Mark in 2020 and Using Abbott’s industry-leading offers a slim design with the lowest FlexNav delivery system, the Navitor TAVI delivery system profile, allowing TAVI system is the latest addition treatment of people with vessels as to the company’s comprehensive small as 5.0 mm. The slim catheter structural heart transcatheter portfolio can accommodate different aortic that offers physicians and patients anatomies for stable, predictable and less invasive options to treat heart accurate valve delivery and placement. diseases. The Navitor Transcatheter Aortic Navitor features a unique fabric Valve and FlexNav Delivery System are cuff (NaviSeal) that works with the approved for investigational use only cardiac cycle to reduce or eliminate in the US. a backflow of blood around the BD’s HPV BD COR System. The BD Viper and provides genotyping a three-pronged approach screening assay LT is in use globally and the BD information from specimens of vaccination, screening, receives EU COR System, launched last year, collected for cervical cancer and treatment to virtually approval is in use across Europe. screening purposes. eliminate cervical cancer. The European Union has set a Becton, Dickinson and The at-home collection In late 2020, WHO goal to introduce organized Company (BD) announced will help address the urgent launched its Global Strategy population-based HPV- the industry’s first self- public health challenge of to Accelerate the Elimination collection claim for human reaching women who do not of Cervical Cancer, papillomavirus (HPV) screening attend routine cervical cancer recognizing the has been CE marked to the IVD screening. Over half of all potential for directive 98/79/EC. cervical cancers are diagnosed in women who have never The new claim allows been screened or have not laboratories and facilities to been screened in the previous process self-collected samples five years, a situation that has via a BD diluents tube using been compounded by the the BD Onclarity HPV Assay on recent global pandemic. either the BD Viper LT or the The BD Onclarity HPV Assay detects and identifies 14 high-risk human papillomavirus (HPV) types in a single analysis June 2021 / FUTURE MEDICINE / 69

based screening and achieve not suitable for surgery, as into an agreement for the Hong Kong, Macau, Singapore, 70% of screening coverage well as patients with very exclusive distribution and Malaysia, Australia and New in the target age group, dilated annulus or very large manufacturing of a range of Zealand. specifying HPV testing of self- coaptation gap, or even with a innovative minimally invasive samples for non-screened or pacemaker.” heart valve products in the Asia Integrated underscreened women; and Pacific region, including China, hemodynamic to manage 90% of screen- In November 2020 Japan, Taiwan, South Korea, system with positive women by 2030. OrbusNeich and P&F entered patient monitor launched OrbusNeich’s Philips launches bicaval valves spectral CT 7500 system Royal Philips announced receive CE mark the integration of its Royal Philips has each patient. Interventional Hemodynamic OrbusNeich Medical introduced its spectral Spectral CT has System and portable Patient Company Ltd and P&F detector-based Spectral Monitor IntelliVue X3, providing Products & Features, under the Computed Tomography demonstrated higher advanced hemodynamic joint partnership OrbusNeich (CT) 7500. sensitivity in detecting measurements at the tableside P&F, announced that the malignant findings and in the cath lab and continuous TricValve Transcatheter Bicaval This latest intelligent has improved readings of monitoring of key vital signs Valves System has received CE system delivers high- incidental findings. With throughout the patient journey. mark approval. quality spectral images Philips spectral detector CT, for every patient on every photons add more value by The integration provides The bicaval valve is scan 100% of the time helping salvage sub-optimal the opportunity for monitoring developed for the treatment of to help improve disease injection scans without during image-guided caval reflux present in cases of characterization, and the need to re-scan the procedures on the Philips severe tricuspid regurgitation, reduce rescans and follow- patients, shortening the image-guided therapy system without the removal of the ups, all at the same dose time to diagnosis. – Azurion, improving workflow defective tricuspid valve. The levels as conventional with comprehensive patient bioprosthesis is available in scans, the company said. The spectral insights records that support timely different diameters for each are available for all clinical decision-making during model (SVC and IVC) and The time-saving spectral patients, from paediatric interventional cardiology specifically designed to adapt workflow is fully integrated, to bariatric, and for any procedures and beyond. to the anatomic features of the enabling the technologist clinical indication, including superior and inferior vena cava. to get the patient on and challenging cardiac scans Uninterrupted patient off the table quickly – with high and irregular monitoring, as patients are “TricValve is a safe and spectral chest scans and heart rates, without moved from holding areas to simple valve system for head scans take less than compromising image the interventional room and patients with severe tricuspid one second, and a full quality, dose or workflow. then on to recovery areas, regurgitation,” said Dr Shaiful upper body spectral scan The spectral workflow can help to improve clinical Azmi Yahaya, head of the can be completed in less enables radiologists to decision making and the timely Cardiology Department at than two seconds – while optimise reading with rich detection of potential adverse the National Heart Institute, still delivering high-quality spectral results and AI- events at every stage of the Kuala Lumpur, Malaysia, in a imaging that allows the based smart tools available patient journey. Incorporating statement. He added, “TricValve physician to rapidly deliver in any reading environment a 12-lead diagnostic ECG, the provides a new treatment a confident diagnosis and with Spectral Magic Glass monitor removes the need option for patients that are effective treatment plan for on PACS. to re-cable the patient or 70 / FUTURE MEDICINE / June 2021

reconnect monitoring, and interventionalists can assess landmark Evolut Low-Risk results showed the Evolut can help lead to reduced the data using the Azurion Trial comparing the minimally TAVR platform was non-inferior procedural preparation time, tableside Touch Screen invasive Evolut transcatheter to surgery for the primary enhanced staff efficiency Module, allowing them to aortic valve replacement endpoint of all-cause mortality and ultimately an enhanced remain focused on their (TAVR) system to the gold or disabling stroke at two years patient experience. patients. The system brings standard of open-heart (4.3% for TAVR versus 6.3% for the latest physiological surgery in characteristically surgery; p< 0.0001 for non- The IntelliVue X3 patient techniques to the younger, healthier aortic inferiority), and trended the monitor can be connected to interventional lab, including stenosis patients. same or lower on all critical the patient from anywhere iFR (instant wave-Free Ratio) events, confirming the earlier in the hospital, after which it measurements, a hyperemia- Presented virtually as a Bayesian statistical analysis stays with them throughout free technique unique to late-breaking clinical trial at presented at the American the interventional procedure, Philips that provides valuable the EuroPCR 2021 e-Course, College of Cardiology (ACC) providing continuous functional information 68th Annual Scientific Session monitoring and registration regarding the severity of in 2019. of their vital signs in the lesions in the coronary IntelliVue IT solution. arteries. In addition, results from the study showed excellent After connecting the Evolut TAVR hemodynamic performance IntelliVue X3 to its docking shows strong for TAVR with statistically station at the tableside of performance at 2 significantly lower mean the Azurion system, clinical years in low-risk aortic valve gradient (9.0 mm staff can monitor all of the trial: Medtronic Hg versus 11.7 mm Hg) and patient’s vital signs including larger effective orifice area pulse oximetry end-tidal Medtronic plc announced than surgery (2.2 cm2 versus CO2, perform hemodynamic the complete two- 2.0 cm2) at two years, (p < analyses and 12-lead ECG year outcomes from the 0.001 for both comparisons). acquisitions, and relay results Numerically lower rates of and waveforms from the lab’s death in the TAVR arm (3.5% control room to the Azurion versus 4.4%), heart failure tableside display. hospitalizations (5.3% versus 7.1%) and disabling stroke From the tableside, the (1.5% versus 2.7%) compared to surgery at two years. The prosthesis-patient mismatch was lower for TAVR compared to surgery at two years with a difference of 2.1% versus 4.9% in the severe category (p<0.001). Valve thrombosis rates showed no signs of increase and remained low at two years (0.3% for TAVR versus 0.2% for SAVR). The global randomized Evolut Low-Risk Trial evaluated three-valve generations (CoreValve, Evolut R and Evolut PRO valves) across a variety of valve sizes in more than 700 patients with severe aortic stenosis deemed to have a low mortality risk with surgery with a predicted risk of mortality of less than 3%. The Evolut TAVR platform is indicated for symptomatic patients with severe aortic stenosis across all surgical risk categories (extreme, high, intermediate and low) in the US and countries that recognize CE Mark. June 2021 / FUTURE MEDICINE / 71

in focus JUST CTTOROLUULELDBCEOIN?VDIDIA’S LAZARO GAMIO AND JAMES GLANZ OFFICIAL COUNTS A CONSERVATIVE SCENARIO A MORE LIKELY SCENARIO A WORSE SCENARIO 26.9 million 404.2 million 539.0 million 700.7 million Reported cases Estimated infections Estimated infections Estimated infections 307,231 600,000 1.6 million 4.2 million Reported deaths Estimated deaths Estimated deaths Estimated deaths 72 / FUTURE MEDICINE / June 2021

The official COVID-19 figures in THE UNDERCOUNT OF serosurveys. India grossly understate the true CASES AND DEATHS IN In each serosurvey, a subset of the scale of the pandemic in the INDIA IS MOST LIKELY EVEN country. Last week, India recorded the MORE PRONOUNCED, FOR population (about 30,000 of India’s largest daily death toll for any country TECHNICAL, CULTURAL AND 1.4 billion people) is examined for during the pandemic — a figure that is LOGISTICAL REASONS COVID-19 antibodies. Once researchers most likely still an undercount. have figured out the share of those could confirm the cause of death are people whose blood is found to contain Even getting a clear picture of equally swamped, she said. antibodies, they extrapolate that data the total number of infections in point, called the seroprevalence, to India is hard because of poor record- Additionally, other researchers arrive at an estimate for the whole keeping and a lack of widespread have found, there are few COVID tests population. testing. Estimating the true number available; often families are unwilling of deaths requires a second layer of to say that their loved ones have died The antibody tests offer one way extrapolation, depending on the share of COVID; and the system for keeping to correct official records and arrive at of those infected who end up dying. vital records in India is shaky at best. better estimates of total infections and Even before COVID-19, about four deaths. The reason is simple: Nearly In consultation with more than a out of five deaths in India were not everyone who contracts COVID-19 dozen experts, The New York Times medically investigated. develops antibodies to fight it, leaving has analyzed case and death counts traces of the infection that the surveys over time in India, along with the A conservative scenario can pick up. results of large-scale antibody tests, To arrive at more plausible estimates to arrive at several possible estimates of COVID infections and deaths in Even a wide-scale serosurvey has for the true scale of devastation in the India, we used data from three its limitations, said Dan Weinberger, an country. nationwide antibody tests, called associate professor of epidemiology at the Yale School of Public Health. India’s Even in the least dire of these, population is so large and diverse estimated infections and deaths that it’s unlikely any serosurvey could far exceed official figures. More capture the full range. pessimistic ones show a toll on the order of millions of deaths — the most Still, Dr. Weinberger said, the catastrophic loss anywhere in the surveys provide a fresh way to calculate world. more realistic death figures. “It gives India’s official COVID statistics report 26,948,800 cases and 307,231 deaths as of May 24. Even in countries with robust surveillance during this pandemic, the number of infections is probably much higher than the number of confirmed cases because many people have contracted the virus but have not been tested for it. On Friday, a report by the World Health Organization estimated that the global death toll of COVID-19 may be two or three times higher than reported. The undercount of cases and deaths in India is most likely even more pronounced, for technical, cultural and logistical reasons. Because hospitals are overwhelmed, many COVID deaths occur at home, especially in rural areas, and are omitted from the official count, said Kayoko Shioda, an epidemiologist at Emory University. Laboratories that June 2021 / FUTURE MEDICINE / 73

RESULTS OF INDIA’S THREE 10,400,000 on triangulation of data from different NATIONAL SEROSURVEYS 271,000,000 sources, which would indicate roughly 500 to 600 million infections.” The antibody tests, that pick up traces of infection from nearly A worse scenario everyone who had contracted COVID-19, offer one way to This scenario uses a slightly higher correct official records estimate of true infections per known case, to account for the current wave. 5,490,000 26.1x The infection fatality rate is also 74,300,000 higher — double the rate of the 226,713 previous scenario, at 0.6 percent — to 6,460,000 13.5x take into account the tremendous stress that India’s health system has 28.5x Aug. 18 to Sept. 20 been under during the current wave. Because hospital beds, oxygen and May 11 to June 4 Dec. 18 to Jan. 6 other medical necessities have been scarce in recent weeks, a greater share CONFIRMED CASES 1 Fundraiser Results by Salesperson of those who contract the virus may be AT THAT POINT dying, driving the infection fatality rate EST. ACTUAL higher. INFECTIONS Explore the numbers EST. OVER Because there are two different CONFIRMED unknowns, there is a wide range of plausible values for the true infection us a starting point,” he said. “I think A more likely scenario and death counts in India, Dr. Shioda that an exercise like this can put some said. “Public health research usually bounds on the estimates.” The latest national seroprevalence provides a wide uncertainty range,” study in India ended in January, before she said. “And providing that kind of Even in the most conservative the current wave, and estimated uncertainty to readers is one of the estimates of the pandemic’s true toll, roughly 26 infections per reported most important things researchers do.” the number of infections is several case. This scenario uses a slightly lower times higher than official reports figure, in addition to a higher infection How we estimated case multipliers suggest. Our first, best-case scenario fatality rate of 0.3 percent — in line assumes a true infection count 15 times with what has been estimated in the So far, India has conducted three higher than the official number of United States at the end of 2020. In national serosurveys during the recorded cases. It also assumes this scenario, the estimated number of COVID-19 pandemic. All three have an infection fatality rate, or I.F.R. — deaths in India is more than five times found that the true number of the share of all those infected who the official reported count. infections drastically exceeded the have died — of 0.15 percent. Both of number of confirmed cases at the time these numbers are on the low end “As with most countries, total in question. of the estimates we collected from infections and deaths are undercounted experts. in India,” said Dr. Ramanan At the time the results of each Laxminarayan, director of the Center survey were released, they indicated The result is a death toll roughly for Disease Dynamics, Economics & infection prevalence between 13.5 double what’s been reported to date. Policy. “The best way to arrive at the and 28.5 times higher than India’s most likely scenario would be based reported case counts at those points in the pandemic. The severity of underreporting may have increased or decreased since the last serosurvey was completed, but if it has held steady, that would suggest that almost half of India’s population may have had the virus. Dr. Shioda said that even the large multipliers found in the serosurveys may rely on undercounts of the true 74 / FUTURE MEDICINE / June 2021

number of infections. The reason, IF INDIA'S LAST SEROSURVEY were calculated before the most recent she said, is that the concentration of HAD HELD STEADY, THAT wave in India, so it could be that the antibodies drops in the months after WOULD SUGGEST THAT overall I.F.R. is actually higher after an infection, making them harder to ALMOST HALF OF INDIA’S accounting for the most recent wave. detect. The number would probably POPULATION MAY The rate also varies greatly by age: be higher if the surveys were able to HAVE HAD THE SARS-COV-2 Typically, the measure rises for older detect everyone who has, in fact, been populations. India’s population skews infected, she said. for “exploring the consequences” of young — its median age is around different values for the infection fatality 29 — which could mean I.F.R. is lower “Those people who were infected a ratio and the ratio of the real number there than in countries with larger older while ago may have not been captured of infections to confirmed cases. Those populations. by this number,” Dr. Shioda said. “So are “the two measures that need to be this is probably an underestimate of the estimated,” Dr. Shaman said. There is also extreme variability true proportion of the population that within the country in terms of has been infected.” How we estimated death rates both infection fatality rate and Many of the infection fatality rate seroprevalence. In addition to the three Like nearly all researchers contacted estimates that have been published national serosurveys, there have been for this article, however, Dr. Shioda said more than 60 serosurveys done at the the estimator provided a good way local and regional level, according to to get a sense of the wide range of SeroTracker, a website that compiles possible death tolls in India. serosurvey data from around the world. Jeffrey Shaman, an epidemiologist In a paper examining infection at Columbia University, said that the rates using serosurvey data from three “slider,” or sliding calculator, is useful June 2021 / FUTURE MEDICINE / 75

GOVT OF INDIA DISMISSES THE NYT locations in India, Dr Paul Novosad, REPORT AS “COMPLETELY BASELESS” an associate professor of economics at Dartmouth College, found huge Government of India had dismissed have to be made so that required variability depending on the population the New York Times report as actions can be taken for it,” he said. being sampled. “We found that age- “completely baseless”, saying it is not specific I.F.R. among returning backed by any evidence. The Union NITI Aayog Member (Health) lockdown migrants was much higher Health Ministry said the report is V K Paul said the report is based on than in richer countries,” he said. “In absolutely false and based on “distorted distorted estimates. \"The estimates contrast, we found a much lower first- estimates”. have been done ad-hoc without any wave I.F.R. than richer countries in the basis... reported cases are a part of a Southern states of Karnataka and Tamil Dismissing the report, Lav Agarwal, larger universe of total infections in Nadu.” Joint Secretary at Ministry of Health any country,” Dr Paul said. He said the and Family Welfare, called the report problem in the analysis arises “when In a country as large as India, even baseless, absolutely false and not certain number is thrown as mortality a small fluctuation in infection fatality backed by evidence. “The question does rate out of that infection”. rates could mean a difference of not arise that COVID-related deaths are hundreds of thousands of deaths, as getting concealed because since the If we go with our sero survey, then seen in the estimates above. beginning, our efforts have been that infection related mortality is 0.05 % all cases and deaths are reported in a and actual mortality is 1.1 %... They are While estimates can vary over time transparent manner. It is also necessary taking 0.3 % - 6 times - on what basis and from region to region, one thing is so that we can understand the overall has it been decided that it is 0.3 % of clear beyond all doubt: The pandemic trajectory of infection and what efforts that large infection number - no basis in India is much larger than the official at all,” Dr Paul said. figures suggest. — Courtesy: The New York Times 76 / FUTURE MEDICINE / June 2021

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G YNPAECEDOILAOTGRYICS GENE THERAPY OFFERS A CURE TO ADA-SCID IN KIDS Scientists have developed a new new immune cells. Autoantibodies may investigational gene therapy that The researchers found that help identify T1D risk could safely restore the immune following pregnancy systems of children suffering from 48 of 50 children who received severe combined immunodeficiency the gene therapy retained their Testing for the presence of due to adenosine deaminase deficiency, replenished immune system autoantibodies could help or ADA-SCID. function two to three years later clinicians in predicting the risk of and did not require additional developing type 1 diabetes among The experimental gene therapy, treatments for their condition. women with gestational diabetes, developed by researchers from the suggests a recently published study University of California, Los Angeles “These findings suggest that presented at the 23rd European (UCLA) and Great Ormond Street this experimental gene therapy Congress of Endocrinology (e-ECE Hospital (GOSH) in London, uses a could serve as a potential 2021). modified lentivirus to deliver the ADA treatment option for infants gene to cells. The therapy involves and older children with ADA- The research suggests that inserting a normal copy of the ADA SCID,” said Anthony S Fauci, women who experience gestational gene into the patient’s own blood- MD, director of NIH’s National diabetes were more likely to develop forming stem cells. The genetically Institute of Allergy and Infectious type 1 diabetes mellitus (T1D) and corrected stem cells then are infused Diseases (NIAID). type 2 diabetes (T2D) later in life. back into the patient, who has received a low dose of the The 23-year long study which chemotherapy medication included nearly 400 women busulfan to help the cells from Finland demonstrated that establish themselves in the presence of islet cell (ICA), the bone marrow and glutamic acid decarboxylase begin producing (GADAs), and insulinoma-associated antigen 2 autoantibodies (IA2A) autoantibodies were associated with T1D. 50 OFNOSRUMBSECRDIPICTIAOLN 78 / FUTURE MEDICINE / June 2021

Premature menopause Wireless sensor ups heart disease risk to remote monitor during Premature natural Project indicated that labor Ultrasound menopause is premature menopause detects associated with a was more common Researchers at circulation 40% greater risk of among black women Northwestern problems in coronary heart disease (15.5%) than white University have placenta (CHD), according to women (4.8%). The developed wireless research presented at lifetime risk of CHD soft sensors that Anew ultrasound-based the American Heart morbidity and mortality can help in remote technique developed by Association’s Epidemiology, was 41% greater in black monitoring of scientists at The National Prevention, Lifestyle and women and 39% greater pregnant mothers Institute of Child Health Cardiometabolic Health in white women with during labor. and Human Development Conference 2021. premature menopause (NICHD), may help monitor compared to their These devices the placenta for impaired The data from over counterparts without include a soft and foetal blood flow in early 10,000 women in the premature menopause. flexible monitor pregnancy. Lifetime Risk Pooling that adheres to the abdomen, The technique, which monitors which uses conventional the contractions ultrasound equipment, and the baby’s detects subtle variations in heartbeat. A the pulsation of foetal blood second monitor, through the arteries at the another small foetal and placental ends of device, wraps the umbilical cord. around a finger measures This potentially enables oxygen levels physicians to identify and peripheral placental abnormalities that temperature. impair foetal blood flow. Higher dose of DHA lowers —Compiled by Divya Choyikutty preterm birth rate Women taking conducted by researchers 1,000 mg of at the University of Kansas docosohexanoic acid Medical Center. (DHA) daily in the last half of pregnancy had a lower Early preterm birth is rate of early preterm birth referred to as birth before than women who took 34 weeks of pregnancy the standard 200 mg which could increase the dose, according to a study risk of infant death and disability. ₹PVAO2GL5E06S.0| 1I0S0S0UE 1 MAY 2019 FUTUREMEDICINEINDIA.COM STUDENTS THE mAb call - 9594 625 231 or ATTACK mail - [email protected] AS AN ADD-ON THERAPY, BIOLOGICS HAVE OPENED UP AN EXCITING FRONT IN SEVERE ASTHMA MEDICINE CASE REPORT MEDICAL PRACTICE PULMONOLOGY GENETICS AVOIDING AN AORTIC VIOLENCE BRONCHIAL MANAGING CATASTROPHE GOES VIRAL THERMOPLASTY THALASSEMIA June 2021 / FUTURE MEDICINE / 79

public health GCLOOVBIDA-L19MDAILSARRUIPATRSESPONSE: WHA World Health Assembly's new resolution urges to step up the pace of progress consistent with WHO’s updated malaria strategy COVID-19 has posed a serious 400 000 lives annually. on the need for equitable and resilient additional challenge to malaria health systems, innovation in tools and responses worldwide. More Strategy refresh approaches, and data-driven strategies than one year into the pandemic, tailored to local conditions. substantial disruptions to malaria Over the last 5 years, WHO’s work on prevention, diagnosis and treatment malaria has been guided by the global Led by the United States of America services persist across the globe. technical strategy for malaria 2016- and Zambia – and co-sponsored According to a recent WHO survey, 2030, adopted by the assembly in May by Botswana, Canada, Chile, China, approximately one-third of countries 2015. The strategy set ambitious goals Colombia, Eswatini, Guyana, Indonesia, reported disruptions in malaria for reductions in case incidence and Kenya, Monaco, Mozambique, Namibia, prevention, diagnosis and treatment death rates of at least 90% by 2030, Philippines, Peru, Sudan, Switzerland, services during the first quarter of with milestones at each 5-year mark United Kingdom of Great Britain and 2021. to track progress. In addition, it called Northern Ireland, and the member for eliminating malaria in 35 countries states of the European Union – the Despite a period of unprecedented and preventing the re-establishment of resolution comes at a critical time as success in global malaria control, with malaria in all countries that are malaria- global progress against malaria stalls an estimated 7.6 million deaths and free. and the COVID-19 pandemic threatens 1.5 billion cases averted since 2000, to further derail efforts to tackle the the global gains in combatting malaria While the updated strategy – disease worldwide. have levelled off in recent years. adopted on 27 May by member states According to the latest World malaria – retains the goals and milestones The resolution urges member report, there were approximately 229 endorsed by the assembly in 2015, it states to step up the pace of progress million new cases of malaria in 2019, is more closely aligned with WHO’s through plans and approaches that an annual estimate that has remained Thirteenth Global Programme of Work are consistent with WHO’s updated virtually unchanged since 2015. (2019-2023) and “Triple Billion” targets, global malaria strategy and the WHO as well as the global universal health guidelines for malaria. It calls on The World Health Assembly, the coverage agenda, a key driver of the countries to extend investment in and main governing body of the World organization’s work worldwide. support for health services, ensuring no Health Organization, has adopted a one is left behind; sustain and scale up new resolution that aims to revitalize Additionally, the strategy’s guiding sufficient funding for the global malaria and accelerate efforts to end malaria, principles have been reordered to place response; and boost investment in a preventable and treatable disease a greater emphasis on the importance the research and development of new that continues to claim more than of country leadership of malaria tools. responses, and there is a stronger focus 80 / FUTURE MEDICINE / June 2021

events BHWAEONARLGLTLDHAECDXAEIRSNEHDVIMAIERADTNIUCNAAOLLUE&NXCPEOS-2021 The virtual expo is expected to witness around 100 global suppliers from Asia, EU and US Worldex India, after its Malaysia, Thailand, USA, Germany, and Medical & Healthcare Virtual Expo and successful Sri Lanka Medical other European countries to showcase Business Matching Week. and Equipment Virtual Expo and promote quality and innovative (SLMEVE) in March, has announced products such as Medical Devices, The participation of international Bangladesh Medical & Healthcare Diagnostic Tools, Surgical Equipments, manufacturers and suppliers at this Virtual Expo – Incorporating Business Medical Textiles & Disposables, Herbal expo will give direct opportunity to Matching Week. The event will be held & Healthcare products, Hospital discuss business cooperation with during 12-15 July, 2021, on its Bee2Bee Equipment & Furniture and more, Bangladesh’s state and private virtual Platform. This virtual expo is an hospitals, medical clinics, health centers, initiative to bridge the gap between the interact with buyers through pre-fixed medical laboratories, state procurement demand and supply of quality medical B2B meetings as well as on the virtual agencies, importers, distributors, and healthcare products in Bangladesh platform during the event days across agents, pharmacies, hotels & resorts, in the current and post pandemic era, the medical and healthcare industry of pharmacies, healthcare retailers, Worldex said in a media statement. Bangladesh. corporate business houses, traders and Bangladesh’s medical device Similar to the Sri Lanka Medical & wholesalers, and others. market was estimated in 2020 at Equipment Virtual Expo, the Federation “We are happy to launch $2.3 billion and is highly import- of Indian Chambers of Commerce oriented. More than 85% of the & Industry (FICCI) shall be forming Bangladesh Medical and Healthcare medical supplies in this market are the India Pavilion for 30-50 Indian Virtual Expo after successfully imported from the US, India, China, companies with the support of the organising Sri Lanka Medical and South Korea and the European Ministry of Commerce & Industry, Equipment Virtual Expo in March countries. Also, in the last financial Government of India at the Bangladesh 2021 that was attended online by budget, the healthcare sector was 2000+ industry representatives given the highest priority in the current on our Bee2Bee platform. Also, we pandemic situation and (as compared arranged 307 B2B meetings through to last fiscal year) and the Bangladeshi the Zoom Meeting App during the government announced 23.44% event. As Bangladesh is a big market additional allocation and incentives with immense opportunities to explore in their budget for 2021-22. With for trade and investment, we believe our the demand for quality healthcare in virtual expo and matchmaking activity state and private healthcare sectors, would be bigger and more successful Bangladesh’s medical devices and than our Sri Lanka event,” said Rajesh equipment market is expected to Bhagat, Managing Director, Worldex achieve one of the fastest growth rates India. in the world in the next 5 years. Bangladesh Medical & Healthcare Virtual Expo and Business Matching According to Worldex India, Week is supported by The Chittagong Bangladesh Medical & Healthcare Chamber of Commerce & Industry, Virtual Expo will witness around Dutch Bangla Chamber of Commerce 100 global suppliers from India, Sri & Industry, Bangladesh, and India- Lanka, Bangladesh, Pakistan, China, Bangladesh Chamber of Commerce & Hong Kong, Japan, Singapore, Korea, Industry, said the organiser— Worldex India Exhibition & Promotion Pvt. Ltd. June 2021 / FUTURE MEDICINE / 81

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guidelines CICONOOFTVLCELILDREI-INCM1T9ICGITNAUELGISDSATEPNILNEDINCGHIEMASENFNDOSLRIFNOGR 84 / FUTURE MEDICINE / June 2021

Key Points is not available), eye protection, gloves, and a gown. • The type of specimen collected when testing for current or past For healthcare providers who are infection with SARS-CoV-2 is based handling specimens, but are on the test being performed and its not directly involved in collection manufacturer’s instructions. Some of (e.g. handling self-collected the specimen types listed below will specimens) and not working within not be appropriate for all tests. 6 feet of the patient, follow Standard Precautions. Healthcare providers • For initial diagnostic testing for should wear a form of source control current SARS-CoV-2 infections, CDC (face mask) at all times while in the recommends collecting and testing healthcare facility. an upper respiratory specimen. Healthcare providers can minimize • This guidance is intended for PPE use if patients collect their own healthcare providers or health specimens while maintaining at least 6 department staff who are collecting feet of separation. specimens from others in a healthcare setting or at the point-of- Respiratory Specimen Collection care. Guidance for self-collection of Respiratory specimens should be specimens can be found here. collected as soon as a decision has been made to test someone, FOR PATIENTS WHO regardless of the time of symptom DEVELOP A PRODUCTIVE onset. The guidance below addresses COUGH, SPUTUM CAN BE options for collecting specimens. COLLECTED AND TESTED FOR SARS-COV-2 WHEN Proper specimen collection is AVAILABLE the most important step in the laboratory diagnosis of infectious CDC has guidance for who should diseases. A specimen that is not be tested, but decisions about who collected correctly may lead to should be tested are at the discretion false or inconclusive test results. of STLT health departments and/or The following specimen collection healthcare providers. Testing for other guidelines follow standard pathogens by the provider should be recommended procedures. done as part of the initial evaluation, as indicated, but should not delay For initial diagnostic testing for testing for SARS-CoV-2, the virus that current SARS-CoV-2 infections, CDC causes COVID-19. recommends collecting and testing an upper respiratory specimen. Contact Collecting and Handling the testing laboratory to confirm Specimens Safely accepted specimen types and follow For healthcare providers collecting the manufacturer instructions for specimens or working within 6 feet of specimen collection. Sterile swabs patients suspected to be infected with should be used for the collection of SARS-CoV-2, maintain proper infection upper respiratory specimens. This control and use recommended is important both to ensure patient personal protective equipment (PPE), safety and preserve specimen which includes an N95 or higher-level integrity. Note that nasopharyngeal respirator (or facemask if a respirator and oropharyngeal specimens are not appropriate for self-collection. Testing lower respiratory tract specimens is also an option. For patients who develop a productive cough, sputum can be collected and tested for SARS-CoV-2 when available. However, the induction of sputum June 2021 / FUTURE MEDICINE / 85

is not recommended due to the possibility of aerosol production during the procedure. Under certain clinical circumstances (e.g., for those receiving invasive mechanical ventilation), a lower respiratory tract aspirate or bronchoalveolar lavage specimen can be collected and tested as a lower respiratory tract specimen. A. Upper respiratory tract Nasopharyngeal specimen (NP) collection /Oropharyngeal (OP) (throat) specimen collection (performed by a trained healthcare provider, only) Use only synthetic fiber swabs with thin plastic or wire shafts that have been designed for sampling the nasopharyngeal mucosa. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and may inhibit molecular tests. CDC recommends collecting only the NP specimen, although an OP specimen is an acceptable specimen type. If both NP and OP specimens are collected, combine them in a single tube to maximize test sensitivity and limit use of testing resources. Instructions for collecting an NP specimen (performed by a trained healthcare provider): • Tilt patient’s head back 70 degrees. • Gently and slowly insert a minitip swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. • Gently rub and roll the swab. • Leave swab in place for several seconds to absorb secretions. • Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the 86 / FUTURE MEDICINE / June 2021

SPECIMEN COLLECTION STEP 3 minitip is saturated with fluid from PROCESS the first collection. Slowly remove swab while rotating it. STEP 1 Specimens can be collected from both • If a deviated septum or blockage nostrils, but it is not necessary if the minitip create difficulty in obtaining the Tilt patient's head back 70 degrees. Gently swab is saturated with fluid from the first specimen from one nostril, use the and slowly insert a minitip swab with a nostril. same swab to obtain the specimen flexible shaft through the nostril parallel to from the other nostril. the palate until resistance is encountered. STEP 4 The distance is equivalent to that from the • Place swab, tip first, into the nostril to the ear of the patient, indicating Place swab, tip first, into the transport tube transport tube provided. contact with the nasopharynx. provided. Once the tip is near the bottom, break the Instructions for collecting an OP STEP 2 swab handle at the swab breakpoint by specimen (performed by a trained bending back and forth or cut it off with healthcare provider): Gently rub and roll the swab, leaving it sterile scissors. in place for several seconds to absorb The swab should fit in the tube comfortably • Insert swab into the posterior secretions. so that the cap can be screwed on tightly to pharynx and tonsillar areas. If a deviated septum or blockage creates prevent leakage and contamination. difficulty in obtaining the specimen from • Rub swab over both tonsillar pillars one nostril, use the same swab to obtain and posterior oropharynx and avoid the specimen from the other nostril. touching the tongue, teeth, and gums. • Place swab, tip first, into the transport tube provided. Nasal mid-turbinate (NMT) specimen (performed by a healthcare provider or the patient after reviewing and following collection instructions): • Use a tapered swab. • Tilt patient’s head back 70 degrees. • While gently rotating the swab, insert swab less than one inch (about 2 cm) into nostril parallel to the palate (not upwards) until resistance is met at turbinates. • Rotate the swab several times against nasal wall and repeat in other nostril using the same swab. • Place swab, tip first, into the transport tube provided. Anterior nasal specimen (performed by a healthcare provider or the patient after reviewing and following the collection instructions): • Insert the entire collection tip of the swab provided (usually ½ to ¾ of an inch, or 1 to 1.5 cm) inside the nostril. • Firmly sample the nasal wall by rotating the swab in a circular path against the nasal wall at least 4 times. • Take approximately 15 seconds to collect the specimen. Be sure to June 2021 / FUTURE MEDICINE / 87

collect any nasal drainage that may to distance from nostrils to outer in the hospital setting) be present on the swab. opening of ear. • Collect 2-3 mL into a sterile, leak- • Repeat in the other nostril using the • Begin gentle suction/aspiration and proof, screw-cap sputum collection same swab. remove catheter while rotating it cup or sterile dry container. gently. • Place swab, tip first, into the • Due to the increased technical skill transport tube provided. • Place specimen in a sterile viral and equipment needs, collection transport media tube. of specimens other than sputum Nasopharyngeal wash/aspirate or Saliva (collected by patient with or from the lower respiratory tract may nasal wash/aspirate (performed by a without supervision): be limited to patients presenting trained healthcare provider) with more severe disease, including Collect 1-5 mL of saliva in a sterile, people admitted to the hospital • Attach catheter to suction leak-proof screw cap container. and/or fatal cases. apparatus. No preservative is required. Follow additional instructions from the Sputum (collected under the • Tilt patient’s head back 70 degrees. healthcare provider or manufacturer. guidance of a trained healthcare • Instill 1 mL-1.5 mL of non- professional) B. Lower respiratory tract bacteriostatic saline (pH 7.0) into Bronchoalveolar lavage, tracheal • For patients who develop a productive one nostril. aspirate, pleural fluid, lung biopsy cough, sputum can be collected and (generally performed by a physician tested when available for SARS- • Insert the tubing into the nostril parallel to the palate (not upwards). Catheter should reach depth equal 88 / FUTURE MEDICINE / June 2021

CoV-2. However, the induction of after each swab removal and leave Goods Regulationsexternal icon and sputum is not recommended. Educate it closed when not in use to avoid U.S. Department of Transportation’s the patient about the difference accidental contamination. (DOT) Transporting Infectious between sputum (deep cough) and Substances Safelypdf iconexternal oral secretions (saliva/spit). Have the • Store opened packages in a icon. Personnel must be trained patient rinse the mouth with water closed, airtight container to to pack and ship according to the and then expectorate deep cough minimize contamination. regulations and in a manner that sputum directly into a sterile, leak- corresponds to their function-specific proof, screw-cap collection cup or • Keep all used swabs away from responsibilities. sterile dry container. the bulk swab container to avoid Note: This is an aerosol-generating contamination. Additional information on packing, procedure and likely to generate shipping, and transporting specimens higher concentrations of infectious • As with all swabs, only grasp the can be found at Interim Laboratory respiratory aerosols. Aerosol- swab by the distal end of the swab, Biosafety Guidelines for Handling generating procedures potentially using gloved hands only. and Processing Specimens Associated put healthcare providers and others with Coronavirus Disease 2019 at an increased risk for pathogen • When patients are self-collecting (COVID-19). exposure and infection. Healthcare swabs under clinical supervision: providers should maintain proper • Hand a swab to the patient only Capillary Fingerstick Specimen infection control, including standard while wearing a clean set of Collection precautions, and wear an N95 or protective gloves. Blood specimens are used for equivalent or higher-level respirator, antibody (or serological) tests and, for eye protection, gloves, and a gown, ANYONE PERFORMING some tests authorized by the US Food when collecting specimens. FINGERSTICK and Drug Administration that are used PROCEDURES SHOULD at the point-of-care, specimens are Handling Bulk-Packaged Sterile ENSURE THAT THEY collected by pricking the skin with a Swabs Properly for Upper ARE NOT PLACING PERSONS fingerstick device. Respiratory Specimen Collection IN THEIR CARE AT RISK FOR Sterile swabs for upper respiratory INFECTION Anyone performing fingerstick specimen collection may be packaged procedures should review the following in one of two ways: • The patient can then self-swab recommendations to ensure that they and place the swab in transport are not placing persons in their care • Individually wrapped (preferred media or sterile transport device at risk for infection. Fingerstick devices when possible) and seal. should never be used for more than one person due to risk of transmission • Bulk packaged • If the patient needs assistance, of other bloodborne infectious you can help the patient place the diseases. When individually wrapped swabs are swab into transport media or a not available, bulk-packaged swabs transport device and seal it. These recommendations apply may be used for specimen collection; not only to healthcare facilities but however, care must be exercised to Storing and Shipping Respiratory also to any setting where fingerstick avoid SARS-CoV-2 contamination of Specimens procedures are performed. any of the swabs in the bulk-packaged Store respiratory specimens at 2-8°C container. for up to 72 hours after collection. Instructions for collecting a capillary If a delay in testing or shipping is blood specimen by fingerstick: • Before engaging with patients expected, store specimens at -70°C or and while wearing a clean set below. • Wash your hands with warm of protective gloves, distribute soapy water and dry hands individual swabs from the bulk Pack and ship suspected and thoroughly or perform hand hygiene container into individual sterile confirmed SARS-CoV-2 patient using an alcohol-based hand disposable plastic bags. specimens, cultures, or isolates as UN sanitizer. 3373 Biological Substance, Category B, • If bulk-packaged swabs cannot be in accordance with the current • Put on gloves for the collection of individually packaged: edition of the International Air the fingerstick blood specimen. • Use only fresh, clean gloves to Transport Association (IATA) Dangerous retrieve a single new swab from • Hold the hand of the person being the bulk container. tested in a downward position and • Close the bulk swab container massage the hand to improve blood flow into the fingers. • Use the middle or ring finger for June 2021 / FUTURE MEDICINE / 89

the specimen collection. Locate a • Gently squeeze the base of the • Properly remove gloves and discard puncture site—it should be slightly finger to form a drop of blood at in appropriate receptacles. Change off-center (lateral side of) on the the puncture site. Avoid squeezing gloves between contacts with each fleshy part of the fingertip. the finger repeatedly or too tightly. person being tested. Change gloves Wipe away the first drop of blood that have touched potentially blood- • Clean the puncture site with a 70% and follow manufacturer instructions contaminated objects or fingerstick isopropyl alcohol pad and allow it to to fill the capillary collection tube or wounds before touching clean air dry. apply the second drop of blood to surfaces. the test device. • Use the manufacturer-provided • Wash and dry hands thoroughly or collection device or a disposable, • Dispose of used fingerstick perform hand hygiene immediately single-use lancet that retracts collection devices and lancets after removal of gloves and before upon puncture for performing immediately at the point of use in touching medical supplies intended the fingerstick. Follow the an approved sharps container. Never for use on other persons. manufacturer’s instructions if using reuse lancets. For an additional visual guide, see their collection device. the Steps for Collecting Finger Stick • Apply firm pressure to the puncture Capillary Blood Using a Microtainer®pdf • Press the fingerstick collection site with clean gauze for five to icon. Note: Follow manufacturer’s device or lancet firmly against ten seconds after collecting the instructions when using another side of the finger pad and specimen to ensure bleeding has collection device. activate to perform the puncture. stopped. If needed, apply self- If using a lancet, make a adhering latex-fee adhesive strip to —Source: CDC single puncture in one smooth site. motion. 90 / FUTURE MEDICINE / June 2021



guidelines &MSCUMRCAEOENRNAMIGYNECGMO, EDSNIISATGONFOSIS Mucormycosis is a fungal infection that mainly affects people who are on medication for other health problems that reduces their ability to fight environmental pathogens. Sinuses or lungs of such individuals get affected after fungal spores are inhaled from the air. This can lead to serious disease with warning sign and symptoms as follows: • Pain and redness around eyes and/ or nose • Fever • Headache • Coughing • Shortness of breath • Bloody vomits • Altered mental status What predisposes • Uncontrolled diabetes mellitus • Immunosuppression by steroids • Prolonged ICU stay • Co-morbidities – post transplant/ malignancy • Voriconazole therapy How to prevent • Use masks if you are visiting dusty construction sites • Wear shoes, long trousers, long sleeve shirts and gloves while handling soil (gardening), moss or manure • Maintain personal hygiene including thorough scrub bath When to Suspect • (in COVID-19 patients, diabetics or immunosuppressed indiviuals ) 92 / FUTURE MEDICINE / June 2021

• Sinusitis – nasal blockade or MONITOR PATIENTS with aim to discontinue rapidly congestion, nasal discharge CLINICALLY AND WITH (blackish/bloody), local pain on the RADIO-IMAGING FOR • Discontinue immunomodulating cheek bone RESPONSE AND TO drugs DETECT DISEASE • One sided facial pain, numbness or PROGRESSION • No antifungal prophylaxis swelling needed and symptoms • Blackish discoloration over bridge of • Extensive Surgical Debridement - to nose/palate • Do not consider all the cases remove all necrotic materials with blocked nose as cases of • Toothache, loosening of teeth, jaw bacterial sinusitis, particularly in • Medical treatment involvement the context of immunosuppression • Install peripherally inserted central and/or COVID-19 patients on • Blurred or double vision with pain; immunomodulators catheter (PICC line) fever, skin lesion; thrombosis & necrosis (eschar) • Do not hesitate to seek aggressive • Maintain adequate systemic investigations, as appropriate (KOH hydration • Chest pain, pleural effusion, staining & microscopy, culture, haemoptysis, worsening of MALDITOF), for detecting fungal • Infuse Normal saline IV before respiratory symptoms etiology Amphotericin B infusion Dos • Do not lose crucial time to initiate • Antifungal Therapy, for at least treatment for mucormycosis 4-6 weeks (see the guidelines • Control hyperglycemia below ) • Monitor blood glucose level post How to manage • Monitor patients clinically and with COVID-19 discharge and also in • Control diabetes and diabetic radio-imaging for response and to diabetics ketoacidosis detect disease progression • Use steroid judiciously – correct • Reduce steroids (if patient is still on) Team Approach Works Best timing, correct dose and duration • Microbiologist • Use clean, sterile water for • Internal Medicine Specialist humidifiers during oxygen therapy • Intensivist • Neurologist • Use antibiotics/antifungals • ENT Specialist judiciously • Ophthalmologist • Dentist Don’ts • Surgeon (maxillofacial/plastic) • Biochemist • Do not miss warning signs June 2021 / FUTURE MEDICINE / 93

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January 2020 / FUTURE MEDICINE / 19

THE SOLUTION TO BAD BODY ODOR IS A GOOD SHOWER, NOT AN EXPENSIVE PERFUME DR RAMAKANTA PANDA Vice chairman and managing director, chief consultant for Cardiovascular Thoracic Surgery at the Asian Heart Institute in Mumbai. Why is there a sudden surge of mucormycosis created havoc among patients. among COVID-19 patients only in India? While, the use of steroids in the treatment of It is time for a retrospection as this is the culmination of the many mistakes that healthcare COVID-19 has to happen at the right time. Steroids providers did not give much attention to while delivering are only effective to fight the effects of COVID, not the care. The first mistake or reason for this is the completely virus directly. It is dangerous and harmful if given early unhygienic and dirty way of delivering oxygen to patients when the virus is replicating. This will reduce the body’s in many places in India, combined with the indiscriminate immunity and facilitate further replication of viruses. use of steroids in the treatment of COVID. Giving steroids unnecessarily or too early to a diabetic patient will raise their sugar level, predisposing them to Typically, medical oxygen (as opposed to industrial further risk of an increase in severity of COVID-19 as well oxygen) is a highly purified version that is more than as predisposing them to the ill-effects of black fungus. 99.5 percent. It is purified through repeated steps of compression, filtration and purification. Even the cylinders And the third mistake that we are potentially in which the liquid oxygen is stored, transported and committing now is even more critical. While it is a used are also rigorously cleaned and disinfected. But it good initiative to ramp up the production of medicine is very important to note that when it is administered to (Amphotericin B) to treat black fungus, we must patients at high flow, it requires humidification. This is understand that this disease kills between 46-96 percent done by passing it through a container filled with sterile of people it infects. Moreover, the bitter truth is that water. The water itself must be sterilized and changed Amphotericin B is very toxic. frequently as per protocol. If the water is not sterile, it is potentially a source of black fungus infection! On the So the real solution is to enforce quality control in other hand, if oxygen is given without humidification, every step, including oxygen production, storage and it will dry the mucous membrane and damage the delivery, as well as to stop the indiscriminate use of inner lining of the lungs. It will also make the sputum steroids to address this new enemy. or secretion very thick to clear out. Both of these have The solution to bad body odor is a good shower, not 98 / FUTURE MEDICINE / June 2021 an expensive perfume. — Article Courtesy: HT Online

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Future Medicine REGISTERED NO. KL/KTM/146/2020-22 June 2021 Total pages in this issue of Future Medicine, including cover: 100 Published on Monthly 8, 2021. Monthy Magazine : RNI Number KERENG/2012/44529