Covid-19 Living Data

Trial CTRI/2021/07/034588
Publication Koudinya Tippabhotla S, SSRN (2022) (preprint)
Dates: 2021-07-01 to 2021-08-24
Funding: Private (Aurobindo Pharma Limited )
Conflict of interest: Yes

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / India Follow-up duration (days): 28
Inclusion criteria	Non-hospitalized, adults aged ≥ 18 and ≤ 60 years laboratory-confirmed (RT-PCR positive) SARSCoV-2 infection presenting with uncomplicated upper respiratory tract symptoms like fever, cough, sore throat, nasal congestion, malaise, headache or any other COVID-19 symptoms without breathlessness or hypoxia (normal saturation).
Exclusion criteria	Respiratory rate ≥ 24/min breathlessness SpO2 ≤ 93% on room air pulse rate < 50 beats per minute positive for hepatitis B or C virus with cirrhosis end-stage liver disease hepatocellular carcinoma elevated liver enzymes absolute Neutrophil Count (ANC) < 500 mm3 platelet count <100,000/μL, or received a platelet transfusion in the previous 5 days immunosuppressive treatments in the previous 30 days or systemic corticosteroids.
Interventions
	Treatment Molnupiravir 800 mg (200mg x 4 capsules orally every 12 hours) for 5 days.
	Control Standard care
Participants
	Randomized participants : Molnupiravir=610 Standard care=610
	Characteristics of participants N= 1220 Mean age : NR 752 males Severity : Mild: n= 1220/ Asymptomatic: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Rate of hospitalization of patients from randomization up to Day 14.
	In the report Rate of hospitalization of patients from randomization till day 14.
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Yes
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	In addition to the preprint article, the study registry was used in data extraction and risk of bias assessment. Neither the protocol or statistical analysis plan were available. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. Some outcomes (e.g. viral negative conversion, WHO Score 7 and above, adverse events) are reported in the paper, but were not pre-specified in the trial registry/protocol. The study (n=1220) achieved the target sample size (n=1220) specified in the trial registry.