Contextualising evidence-based recommendations for the second wave of the COVID-19 pandemic in India
Authors: Satchit Balsari, Zarir Udwadia, Ahmed Shaikh, Abdul Ghafur, Sushila Kataria
Journal: The Lancet Infectious Diseases (2021)

During the second wave of the COVID-19 pandemic in India, which began in March, 2021, demand on the health-care system has far exceeded capacity. Despite crippling shortages, patients are prescribed a battery of ineffective therapeutic interventions.1Pulla P Covid-19: India's slow moving treatment guidelines are misleading and harming patients.BMJ. 2021; 372: n278Crossref PubMed Scopus (6) Google Scholar Ivermectin, hydroxychloroquine, and herbal cocktails continue to receive state patronage.2López-Medina E López P Hurtado IC et al.Effect of ivermectin on time to resolution of symptoms among adults with mild COVID-19: a randomized clinical trial.JAMA. 2021; 325: 1426-1435Crossref PubMed Scopus (257) Google Scholar, 3Singh B Ryan H Kredo T Chaplin M Fletcher T Chloroquine or hydroxychloroquine for prevention and treatment of COVID-19.Cochrane Database Syst Rev. 2021; 2CD013587PubMed Google Scholar, 4AIIMS Covid Information PortalClinical guidance for management of adult Covid-19 patients.https://covid.aiims.edu/clinical-guidance-for-management-of-adult-covid-19-patients/Date accessed: May 18, 2021Google Scholar On May 8, 2021, 2-deoxy-D-glucose was given emergency authorisation, stating that it will "save precious lives" without any published evidence that it impacts mortality.5Press Information Bureau DelhiDCGI approves anti-COVID drug developed by DRDO for emergency use.https://pib.gov.in/PressReleasePage.aspx?PRID=1717007Date: 2021Date accessed: May 18, 2021Google Scholar An entrenched culture of polypharmacy and gestalt-driven practice among physicians has resulted in indiscriminate and unwarranted use of remdesivir, favipiravir, azithromycin, doxycycline, plasma therapy, and most recently baricitanib and bevacizumab, regardless of disease severity or drug efficacy. Excessive and inappropriate use of steroids could be contributing to the alarming rise of mucormycosis in patients recovering from COVID-19. In rural India, where health-care infrastructure is threadbare, and families are poor, patients can ill afford such expensive mistakes. Honing in on the most high yield and affordable interventions, we propose recommendations for testing and management, optimised to India's current resource-constrained context (table). Every clinical touchpoint should be used to underscore masking, distancing, and vaccination.TableEvidence-base interventions for COVID-19 patients not requiring hospitalisationWhoWhereHow (impact optimisation strategies)Mild disease*Patients with mild symptoms and SpO2≥94%.TreatInhaled budesonide (might help)Self-administeredHomeInstructional videosAntipyreticSelf-initiatedHomeSpecific drug name, dose, and frequencyMonitor pulse oximeter and respiratory rateSelf-initiatedHomeInstructional videosReport test and clinical statusCare coordinatorHomeCommunity-based, private, or public sector central coordinationOtherMaskingSelf-initiatedHomeInstructional videosVentilate the isolation room, when feasibleSelf-initiatedHomeInstructional videosReinforce the importance of completing or initiation vaccination after recovery, including for all family membersAll providers..Instructional videosModerate disease†Patients with SpO2<94 and ≥90.TreatOxygenation via concentrator or cylinder (NB: potential risk to inadequately protected care providers); target SpO2 above 92%Family assisted or trained personnelAnyInstructional videos on caregiver PPE, correct use, and dosingOxygenation via non-invasive ventilation or high flow nasal cannula (NB: potential risk to inadequately protected care providers); target SpO2above 92%; few will have access to thisClinicianAnyPronationSelf-initiated or assistedAnyInstructional videosDexamethasone (or other equivalents) only if requiring respiratory supportClinicianAnyDosage protocols for cliniciansAntipyreticSelf-initiatedAnySpecific drug name, dose, and frequencyAnticoagulation, for patients admitted to care facilities, and only under medical supervisionTrained personnelBridge facility or hospitalInstructional videos on administrationDo not use ivermectin and hydroxychloroquine......TestRandom blood glucoseTrained personnelAnyDecision support system or telemedicine to higher tier care provider if uncontrolled or new diabetesCT not indicated in most cases......Report clinical statusDesignated coordinator..Standardised daily logs of vital signs and interventionsDisease severity classification as per the Ministry of Health and Family Welfare, Government of India. PPE=personal protective equipment. SpO2=oxygen saturation.* Patients with mild symptoms and SpO2≥94%.† Patients with SpO2<94 and ≥90. Open table in a new tab Disease severity classification as per the Ministry of Health and Family Welfare, Government of India. PPE=personal protective equipment. SpO2=oxygen saturation. Where RT-PCR test turnaround time is lengthy, or when tests are unavailable, CT scans are being routinely prescribed for diagnosing infection from SARS-CoV-2. Serial scans are prescribed for prognostication; high CT severity scores—regardless of clinical presentation—then inadvertently trigger unwarranted hospitalisations. This practice is neither standard of care nor an option for most patients. In fact, we argue that in the throes of this surge, it would be prudent to initiate treatment for presumed infection if clinically warranted, and have all with mild symptoms isolate for 14 days or until a test result is available.6Centers for Disease Control and PreventionCOVID-19: when to quarantine.https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.htmlDate: 2021Date accessed: April 27, 2021Google Scholar In early May, 2021, national guidelines were finally relaxed to allow such syndrome-based diagnosis, ending a year of delayed or denied hospital admissions due to slow or unavailable testing. When options for oxygenation or timely transport to higher levels of care are available, oxygen saturation, a reliable predictor of mortality in COVID-19, and measured via cheaply and widely available pulse-oximeters, should suffice for risk stratification.7Mejía F Medina C Cornejo E et al.Oxygen saturation as a predictor of mortality in hospitalized adult patients with COVID-19 in a public hospital in Lima, Peru.PLoS One. 2020; 15e0244171Crossref PubMed Scopus (108) Google Scholar Routinely prescribed expensive laboratory tests such as C-reactive protein, ferritin, interleukin-6, and D-dimer, will have little bearing on clinical outcomes where there are no viable options for basic therapeutic care. Even in urban India, physicians must consider recommending such tests only when there is evidence that interventions are based on their interpretation change outcomes and are actually feasible. For nearly a year, patients were being advised institutional isolation, regardless of disease severity or ability to isolate at home. For patients with mild disease, home-based care and self-monitoring with a pulse oximeter—as has long been appropriate—has finally gained widespread traction, from sheer necessity. Clear directives (and telemedicine support, where possible) will prevent unwarranted presentations to the hospital. Most patients with hypoxia might only need oxygenation and proning. Current evidence supports the use of steroids such as dexamethasone only among those needing oxygen or invasive respiratory support.8Caputo ND Strayer RJ Levitan R Early self-proning in awake, non-intubated patients in the emergency department: a single ED's experience during the COVID-19 pandemic.Acad Emerg Med. 2020; 27: 375-378Crossref PubMed Scopus (253) Google Scholar, 9Horby P Lim WS Emberson JR et al.Dexamethasone in hospitalized patients with Covid-19.N Engl J Med. 2021; 384: 693-704Crossref PubMed Scopus (7056) Google Scholar A few patients might also benefit from prophylactic doses of anticoagulation that can be administered by trained family members.10Sadeghipour P Talasaz AH Rashidi F et al.Effect of intermediate-dose vs standard-dose prophylactic anticoagulation on thrombotic events, extracorporeal membrane oxygenation treatment, or mortality among patients with COVID-19 admitted to the intensive care unit: the INSPIRATION randomized clinical trial.JAMA. 2021; 325: 1620-1630Crossref PubMed Scopus (488) Google Scholar Patients can be taught pronation via effective educational aids. A severe shortage of beds and unreliable power availability threaten other key treatment possibilities in rural India, as oxygen concentrators will need continuous electricity or back-up generators, and oxygen cylinders are expensive to procure and transport. The justified, ad hoc, and self-organised measures to procure and administer oxygen, however, risk inadequate oxygen therapy, rendering these often Herculean efforts clinically futile. A vast number of oxygen concentrators and ventilators have been mobilised internationally. On May 8, 2021, the Supreme Court of India appointed a task force to oversee oxygen allocation. It is imperative that recommendations for distribution be coupled with human-in-the-loop solutions where technical know-how to operate these devices is expanded expeditiously via online adjuncts. The government has also directed India's non-allopathic AYUSH doctors to provide COVID-19 care. It is crucially important that this expanded workforce not amplify missteps from the preceding year. Hypoxic patients who do not need invasive mechanical ventilation can be cared for at makeshift but monitored, protocolised health-care facilities. Despite the bed shortage, and revised national guidelines, many patients are not being discharged home until their RT-PCR test is negative. There is no evidence that patients need hospitalisation once they are clinically stable for discharge. When isolating at home is unfeasible, they could be sent to recovery centres. Indigenous rural solutions such as isolating patients elsewhere on the farm are not unreasonable, provided family members can provide care. It is time to double down on effective interventions. The lack of critical care capacity necessitates open discussions about goals of care. We are all practicing physicians and recognise how hard it is to communicate futility to family members, especially in these desperate times. Truth, however, will protect families from crushing debt, and in some cases, financial ruin. Adherence to science, even now, will probably be the least destructive path forward. ZU serves on the Maharashtra Covid Task Force and National Task Force constituted by the Supreme Court of India; and has received honoraria or grants from AstraZeneca and Glenmark. AG has received grants from Cipla, Glenmark, Pfizer, Sanofi, Astellas, Mylan, Natco, Biomerioux, Bharath Serum, and GlaxoSmithKline. All other authors declare no competing interests.