Table 1.
Clinical studies evaluating molnupiravir therapeutic effects in COVID‐19 based on published articles
| Design (identified number) | Target participant | Participant size | Dosage | Results | Ref. | |||
|---|---|---|---|---|---|---|---|---|
| Efficacy | Safety | Virology | Others | |||||
| Randomized‐controlled (standard‐of‐care), open‐label, dose‐escalating. Phase I (NCT04746183) | Adult outpatients with SARS‐CoV‐2 infection confirmed by polymPCR within 5 days of symptom onset) | 18 participants (randomized 2:1 in groups of six participants to receive 300, 600, or 800 mg of molnupiravir orally twice daily for 5 daysor to receive a placebo) | Three dose cohorts (300, 600, and 800 mg molnupiravir) were studied sequentially | ‐ | Molnupiravir was found to be safe and well tolerated | ‐ | ‐ | 43 |
| Randomized, placebo‐controlled, double‐blind. Phase I (NCT04392219) | Subjects ranged in age from 19 to 60 years, with a mean body mass index of 24.4 to 25.4 kg/m2 | 130 participants (64 subjects received a single dose of molnupiravir/placebo, 55 subjects received a single dose of molnupiravir/placebo BID for 5.5 days, and 10 subjects received a single dose of 200 mg molnupiravir in the fed state followed by a single dose of 200 mg molnupiravir in the fasted state following a 14‐day washout period) | Single‐ascending‐ dose between 50 and 1600 mg molnupiravir or placebo | Molnupiravir was well tolerated at doses of 50 to 800 mg administered BID for 5.5 days and at single doses up to 1600 mg. In addition, molnupiravir is well absorbed when it is taken orally, and food intake has little effect on how well it is absorbed | Clinical laboratory, vital sign, and electrocardiogram data revealed no clinically significant findings or dose‐related trends | ‐ | This study found no clinically significant changes in hematological parameters | 44 |
| Multiple doses between 50 and 800 mg molnupiravir or placebo BID for 5.5 days | ||||||||
| Single dose of 200 mg molnupiravir in the fed state followed by a single dose of 200 mg molnupiravir in the fasted state | ||||||||
| Randomized, placebo‐controlled, multicenter, double‐blind. Phase IIa trial (NCT04405570) | Unvaccinated participants who had been diagnosed with SARS‐CoV‐2 and had symptoms lasting less than 7 days | 204 participants (202 receiving at least one dose of molnupiravir or placebo) | 200 mg molnupiravir or a placebo (1:1), followed by a 3:1 ratio of molnupiravir (400 or 800 mg) or a placebo, orally twice daily for 5 days | 800 mg molnupiravir versus placebo supports molnupiravir antiviral efficacy at the 800 mg dose | It was well tolerated, with no increase in treatment‐related or serious adverse events when compared to placebo‐treated participants | Molnupiravir decreased the isolation of infectious viruses, decreased the time required for viral RNA to be cleared, increased the proportion of participants who eliminated SARS‐CoV‐2 viral RNA | There are no safety signals or evidence of hematologic, renal, or hepatic toxicity at any doses | 45 |
| Randomized, placebo‐controlled, double‐blind. Phase II/III (NCT04575584) | Patients aged 18 years or older who require in‐hospital treatment for laboratory‐confirmed COVID‐19 infection with symptoms manifesting ten or fewer days prior to randomization | 304 participants (218 participants received at least one dose of molnupiravir, while 75 received a placebo) | 200, 400, or 800 mg molnupiravir (1:1:1:1), twice daily for 5 days | There is no indication of a treatment effect. | No safety concerns with molnupiravir were identified | Molnupiravir and placebo had no discernible effect on SARS‐CoV‐2 RNA viral load reduction from baseline | There is no evidence of toxicity to the blood, pancreas, or liver | 46 |
| Randomized, placebo‐controlled, double‐blind global. Phase II/III (NCT04575597) | Participants had mild or moderate laboratory‐confirmed COVID‐19 disease with onset of signs/symptoms up to (and including) 7 days before randomization | 302 participants to receive either molnupiravir 200 mg (n = 75), 400 mg (n = 77), or 800 mg (n = 76) or a placebo (n = 74) | Participants were randomly assigned to receive 200, 400, or 800 mg of molnupiravir or a placebo for 5 days and followed through Day 29 | The findings are insufficient to establish a meaningful metric of clinical efficacy. Regardless of treatment, the majority of participants experienced sustained resolution or improvement of COVID‐19 signs/symptoms by Day 29 and had a similar time to progression of COVID‐19 signs/symptoms through Day 29 | Molnupiravir was not associated with dose‐limiting adverse events and distinct safety signals | By Day 5, 5.6%, 20.6%, and 12.7% of participants in the 200‐, 400‐, and 800‐mg molnupiravir groups, respectively, had undetectable SARS‐CoV‐2 RNA levels, compared to 3.6% of placebo participants | Molnupiravir was not associated with clinically significant laboratory test result abnormalities, including hematologic parameters | 47 |
| Randomized, placebo‐controlled, double‐blind. Phase III (NCT04575597) | Nonhospitalized, unvaccinated adults with mild‐to‐moderate COVID‐19 infection confirmed in the laboratory and at least one risk factor for severe COVID‐19 illness and had symptom after 5 days | 1433 participants (716 were assigned to receive molnupiravir and 717 to receive placebo) | 800 mg molnupiravir or a placebo twice a day, for 5 days | Participants receiving molnupiravir had a lower risk of hospitalization or death after 29 days: 6.8% versus 9.7% in the placebo group | No safety concerns with molnupiravir were identified | Molnupiravir treatment was associated with a greater reduction in mean viral load from baseline than placebo treatment | ‐ | 48 |
Abbreviations: COVID‐19, coronavirus disease 2019; PCR, polymerase chain reaction; SARS‐CoV‐2, severe acute respiratory syndrome coronavirus 2.