Table 2.
Phase | N; Types of study | Severity of COVID-19 | Results and side effects | Ref. |
---|---|---|---|---|
Phase 1 studies | 130; DBRPC | NA | Two phase-1 studies of molnupiravir revealed that the dose of 1600 mg daily is safe and tolerable and has no severe adverse events up to 5.5 days. | [11] |
18; R, OL | Mild or moderate | [16] | ||
Phase 2 studies | 202; DBRPC | Mild or moderate | A phase 2 study with molnupiravir 800 mg twice a day showed a notably lower time to clearance (RNA negativity) than the placebo (log-rank p value = 0.013) in mild to moderate COVID-19. | [10] |
Phase 3 studies | Notable reduction in the risk of hospital reception or death (up to 50% (p = 0.0012)) has been seen in phase 3 DBRPC study in non-hospitalized COVID-19 (was not observed notable advantage with molnupiravir in the later step of modest to severe COVID-19). |
DBRPC double-blind randomized placebo-controlled, OL open-label, NA not applicable/available.