ABSTRACT
Background At the peak of the coronavirus disease 2019 (COVID-19) pandemic, the need for an orally administered agent to prevent the progression of acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection became increasingly evident, which was the impetus behind our investigations with molnupiravir. Molnupiravir has been shown to be effective in preventing hospitalizations and/or clinical complications in patients with mild-to-moderate COVID-19. In this study, we evaluate the efficacy and safety of molnupiravir in Indian patients with mild SARS-CoV-2 infection and at least one risk factor for disease progression (CTRI/2021/05/033739). Methodology This was a phase III, multicenter, randomized, open-label, controlled study conducted in Indian adults aged 18-60 years with mild SARS-CoV-2, reverse transcription polymerase chain reaction (RT-PCR)-positive within 48 hours of enrollment in the study, and within five days of first symptom onset. Enrolled patients were randomized to treatment arms in a 1:1 ratio to receive molnupiravir or placebo in addition to the standard of care (SoC) for SARS-CoV-2 infection. The SoC was in compliance with Government of India guidelines that were in force at the time. The primary endpoint was the rate of hospitalization up to day 14. Safety endpoints included incidence of adverse events (AEs). Results Eligible patients were randomized in a 1:1 ratio to receive molnupiravir in addition to SoC treatment (n = 608) or SoC alone (n = 610). In the molnupiravir group, nine (1.48%) patients required hospitalization versus 26 (4.26%) patients in the control group (risk difference = -2.78%; 95% CI = -4.65, -0.90; p = 0.0053). Overall, 45 (3.70%) patients reported 47 AEs during the study, most of which were mild and resolved completely. The molnupiravir group reported 30 AEs compared to 17 AEs in the control group. Headache and nausea were the two most commonly reported AEs. Conclusions The molnupiravir arm showed a lower rate of hospitalization and a shorter time for the improvement of clinical symptoms coupled with early RT-PCR negativity. Molnupiravir was well tolerated, and AEs were mild and rare. The addition of molnupiravir to standard therapy has the potential to prevent the progression of mild COVID-19 disease to the severe form.
ABSTRACT
BACKGROUND AND OBJECTIVES: During Corona Virus Disease-19 (COVID-19) pandemic, it has been estimated that approximately 10% of health care professionals (HCPs) have been diagnosed contacting COVID-19. Aerosol-generating procedures have led to change in safety practices among HCPs. We thus evaluated the efficacy of the endoscopic safety measures among HCPs posted in the endoscopy unit. METHODS: In this retrospective analysis, all endoscopic procedures performed over a period of 4 months, from 1 April to 31 July 2020 were included. We noted indications and number of COVID-positive procedures as well as comprehensive screening of HCPs posted in our endoscopy unit. The aim of the study was to evaluate the incidence and outcome of COVID-19 among HCPs. RESULTS: Three thousand four hundred and sixty procedures were included in the analysis. Indications were divided as urgent (n = 190, 5.49%), semi-urgent (n = 553, 16%) and non-urgent group (n = 2717, 78.52%). Thirty-four procedures (0.98%) were done on diagnosed COVID-19 patients. The most common indications were gastrointestinal bleed (n = 12/34, 35.30%) followed by biliary sepsis (n = 9/34, 26.5%). Among the HCPs, the incidence of symptomatic COVID-19 was 6.58% (n = 5/76). All HCPs recovered with excellent outcomes. A comprehensive screening showed 7.90% (n = 6/76) HCPs having Immunoglobulin G (IgG) antibody in their sera. CONCLUSION: Addition of safety measures in endoscopy leads to low risk of transmission among HCPs.