PMID- 36532902
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221222
IS  - 2168-8184 (Print)
IS  - 2168-8184 (Electronic)
IS  - 2168-8184 (Linking)
VI  - 14
IP  - 11
DP  - 2022 Nov
TI  - Efficacy and Safety of Molnupiravir in Mild COVID-19 Patients in India.
PG  - e31508
LID - 10.7759/cureus.31508 [doi]
LID - e31508
AB  - 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.
CI  - Copyright (c) 2022, Sinha et al.
FAU - Sinha, Shubhadeep
AU  - Sinha S
AD  - Clinical Development and Medical Affairs, Hetero, Hyderabad, IND.
FAU - N, Kumarasamy
AU  - N K
AD  - Infectious Diseases Medical Centre, Voluntary Health Services, Chennai, IND.
FAU - Suram, Vasanth Kumar
AU  - Suram VK
AD  - Department of Medicine, Gandhi Hospital, Hyderabad, IND.
FAU - Chary, Sreenivasa S
AU  - Chary SS
AD  - Clinical Development and Medical Affairs, Hetero, Hyderabad, IND.
FAU - Naik, Sunil
AU  - Naik S
AD  - General Medicine, Rajiv Gandhi Institute of Medical Sciences, Srikakulam, IND.
FAU - Singh, Veer Bahadur
AU  - Singh VB
AD  - General Medicine, Jawahar Lal Nehru Medical College, Bikaner, IND.
FAU - Jain, Manish K
AU  - Jain MK
AD  - Pulmonology, Maharaja Agrasen Superspeciality Hospital, Jaipur, IND.
FAU - Suthar, Chandra P
AU  - Suthar CP
AD  - Medicine, Dana Shivam Heart & Superspeciality Hospital, Jaipur, IND.
FAU - Borthakur, Swapnav
AU  - Borthakur S
AD  - Internal Medicine, Down Town Hospital, Guwahati, IND.
FAU - Sawardekar, Vinayak
AU  - Sawardekar V
AD  - General Medicine, St. George's Hospital, Mumbai, IND.
FAU - Sk, Noushadali
AU  - Sk N
AD  - General Medicine, A. C. Subba Reddy Government Medical College, Nellore, IND.
FAU - Reddy, Naveen
AU  - Reddy N
AD  - Internal Medicine, AIG Hospitals, Hyderabad, IND.
FAU - Talluri, Leela
AU  - Talluri L
AD  - Clinical Development and Medical Affairs, Hetero, Hyderabad, IND.
FAU - Thakur, Pankaj
AU  - Thakur P
AD  - Clinical Development and Medical Affairs, Hetero, Hyderabad, IND.
FAU - Reddy, Mohan
AU  - Reddy M
AD  - Clinical Development and Medical Affairs, Hetero, Hyderabad, IND.
FAU - Panapakam, Muralidhar
AU  - Panapakam M
AD  - Clinical Data Management, Hetero, Hyderabad, IND.
FAU - Vattipalli, Ramya
AU  - Vattipalli R
AD  - Clinical Development and Medical Affairs, Hetero, Hyderabad, IND.
LA  - eng
PT  - Journal Article
DEP - 20221114
PL  - United States
TA  - Cureus
JT  - Cureus
JID - 101596737
PMC - PMC9751243
OTO - NOTNLM
OT  - efficacy and safety
OT  - molnupiravir
OT  - oral antiviral drug
OT  - phase 3 study
OT  - sars-cov-2 infection
COIS- The authors have declared that no competing interests exist.
EDAT- 2022/12/20 06:00
MHDA- 2022/12/20 06:01
PMCR- 2022/11/14
CRDT- 2022/12/19 04:24
PHST- 2022/11/14 00:00 [accepted]
PHST- 2022/12/19 04:24 [entrez]
PHST- 2022/12/20 06:00 [pubmed]
PHST- 2022/12/20 06:01 [medline]
PHST- 2022/11/14 00:00 [pmc-release]
AID - 10.7759/cureus.31508 [doi]
PST - epublish
SO  - Cureus. 2022 Nov 14;14(11):e31508. doi: 10.7759/cureus.31508. eCollection 2022 
      Nov.