Covid-19 Living Data

Trial NCT04575584
Publication MOVe-IN - Arribas J, N Engl J Med Evidence (2021) (published paper)
Dates: 2020-10-19 to 2021-01-12
Funding: Private (Merck Sharp & Dohme Corp.)
Conflict of interest: Yes

Methods
	RCT Blinding: double blinding
	Location : Multicenter / Brazil, Chile, Colombia, France, Israel, Mexico, Philippines, Poland, Russian Federation, South Africa, Republic of Korea, Spain, UK, Ukraine, USA Follow-up duration (days): 28
Inclusion criteria	Adult patients requiring in-hospital treatment for laboratory-confirmed Covid-19 sign/symptom onset 10 or fewer days before randomization
Exclusion criteria	Critical illness due to Covid-19 (i.e., respiratory failure [defined as need for invasive or noninvasive mechanical ventilation, oxygen delivered by high-flow nasal cannula, or extracorporeal membrane oxygenation] shock, or multiorgan dysfunction/failure) severely immunocompromised persons who are not expected to have a Covid-19 disease course and/or clinical response to study treatment typical of the general population low platelet count (<100,000/μl or platelet transfusion ≤5 days prior) SARS-CoV-2 vaccination
Interventions
	Treatment Molnupiravir 200mg 200 mg orally twice daily for 5 days Molnupiravir 400mg 400 mg orally twice daily for 5 days Molnupiravir 800 mg orally twice daily for 5 days
	Control Placebo
Participants
	Randomized participants : Molnupiravir 200mg=75 Molnupiravir 400mg=75 Molnupiravir=76 Placebo=78
	Characteristics of participants N= 304 Mean age : NR 172 males Severity : Mild: n=148 / Moderate: n=134 / Severe: n=11 Critical: n=0 Number of vaccinated participants: 0
Primary outcome
	In the register 1) Time-to-sustained recovery [ Time Frame: Up to 29 days ]; 2) Percentage of participants with an adverse event (AE) [ Time Frame: Up to 7 months ]; 3) Percentage of participants who discontinued study intervention due to an AE [ Time Frame: Up to 6 days ]
	In the report Safety and sustained recovery: 1) Rates of adverse events reported during the safety follow-up period (from randomization through 14 days after end of treatment); 2) Adverse events leading to discontinuation of study intervention reported during the safety follow-up period; 3) Sustained recovery, defined as participants being alive and either not hospitalized or medically ready for hospital discharge through day 29
Documents available	Protocol Yes. In English Statistical plan Yes 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 published article, the registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. There were no major differences between the registry and the article in populations, procedures, interventions or outcomes: the primary outcomes in the article reflected those in the registry, but different timepoints are reported for adverse events. Recruitment was terminated for commercial reasons and so the study (n = 304) did not achieve its target sample size (n = 1300). This study was updated on September 14th, 2022 with data extracted from the registry.