Covid-19 Living Data

Trial CTRI/2021/06/033938
Publication Kumarasamy N, CROI (2022) (unpublished results)

Funding: Private (Dr Reddys Laboratories Limited)
Conflict of interest: *

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / India Follow-up duration (days): 14
Inclusion criteria	Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements Male or female patients between 18 and 60 years of age (both inclusive) Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected â?¤5 days prior to randomization). Note: If rapid antigen test has been performed and patient found positive then RT-PCR will be performed prior to randomization Patients with mild COVID-19 and have following symptoms and signs prior to randomization â?¤5 days prior to randomization: Upper respiratory tract symptoms (&/or fever) without shortness of breath or hypoxia. As defined by AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring Group (Directorate General Of Health Services) Ministry of Health & Family Welfare, Government of India- clinical guidance for management of adult COVID-19 patients, dated 22-Apr-2021 Is willing and able to take oral medication Willingness to comply with study instructions for its duration as indicated by written informed consent from the patient
Exclusion criteria	Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization Pregnancy or lactation History of allergy or hypersensitivity to Molnupiravir or any other treatment component based on investigators assessment Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation Tested positive for Human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection Abnormal laboratory findings at screening: Aspartate aminotransferase (AST) >3X upper limit of normal, Alanine aminotransferase (ALT) >3X upper limit of normal, Absolute neutrophil count <500/mm3 or per microliter, Platelet count <100,000 per microliter or /mm3 Patients who received a platelet transfusion in the 5 days prior to randomization Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: Participants who are not expected to survive longer than 48 hours at the time of randomization, or Participants with a recent history of mechanical ventilation, or Participants with conditions that could limit gastrointestinal absorption of capsule contents Receipt of following medication/treatment: Ongoing Remdesivir, Favipiravir or any other anti-viral drug, for COVID-19 treatment, Biological therapy (especially, monoclonal antibody, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit) Participation in any clinical study with an investigational drug, biologic, or device within 1 month prior or within 5 half-lives (of the drug/ biologic) prior to the randomization (whichever is longer)
Interventions
	Treatment Molnupiravir 800 mg orally twice daily for 5 days
	Control Standard care
Participants
	Randomized participants : Molnupiravir=608 Standard care=610
	Characteristics of participants N= 1218 Mean age : NR 0 males Severity : Mild: n= 1218/ Asymptomatic: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Rate of hospitalization Timepoint: Randomization up to Day 14
	In the report Rate of hospitalization up to day 14
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Not reported
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	The conference abstract and the trial registry were used in data extraction and risk of bias assessment. The registry primary outcome reflects the reported primary outcome. The study (N =1218) achieved the target sample size specified in the trial registry (N =1218). This trial is still ongoing. Results on incidence of viral negative conversion and clinical improvement are reported with percentages only; we were unable to calculate the number of events since the denominators for the outcomes are unclear.