Table 2.

Completed clinical phase-I and II trials of molnupiravir.

Phase	Registered No.	Participants	Study Site	Study Design	Primary Aims	Principal Results	Reference
I	NCT04392219	64 healthy volunteers	United Kingdom	Randomized, double-blind, placebo-controlled, single-center	Effects of single or multiple doses and food intake on pharmacokinetics	Similar pharmacokinetics after the administration of single or multiple doses; limited effects of food intake on absorption	[29]
I	NCT04746183	18 adults within 5 days of COVID-19 symptom onset	United Kingdom	Dose-escalating, open-label, randomized-controlled, single-center	Safety and tolerability of multiple ascending doses to recommend a dose for the phase-II trial	Well tolerated at 400, 600, or 800 mg doses	[30]
II	NCT04405739	78 adults with onset of COVID-19 signs or symptoms within 7 days	United States	Double-blind, randomized, placebo-controlled, multicenter trial	Rates of viral clearance, by viral cultures in nasopharyngeal sites, as efficacies of molnupiravir	Compared to the placebo, the efficacies were significantly different on day 5, but not on day 3 after administration	[31]
II	NCT04405570	202 outpatients with onsets of COVID-19 symptoms within 7 days	United States	Double-blind, randomized, placebo-controlled, multicenter trial	Efficacies of molnupiravir based on the proportions of undetectable SARS-CoV-2 and alterations in the viral load in nasopharyngeal swabs detected using RT-PCR	Compared to the placebo, the effect appears significant on days 3 and 5 after administration	[32]