Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06667700 | A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023) | PHASE3 | RECRUITING | 3,082 | — | — | Dec 2, 2024 | Jan 26, 2031 | Jun 5, 2026 | 224 | United States, Argentina +22 |
| NCT04939428 | Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013) | PHASE3 | COMPLETED | 2,441 | — | — | Aug 11, 2021 | Nov 16, 2022 | Sep 26, 2024 | 226 | United States, Argentina +21 |
| NCT04575597 | Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002) | PHASE2 | COMPLETED | 1,735 | — | — | Oct 19, 2020 | May 5, 2022 | Jun 28, 2023 | 173 | United States, Argentina +21 |
Hospitalization is defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms or facilities created to address hospitalization needs specifically for COVID-19. Hospitalization and death may be due to any cause. An MAV is defined as any unscheduled, nonroutine healthcare visit where the participant is evaluated by a licensed (according to local/national guidelines) healthcare provider. As prespecified by the protocol, the percentage of participants who experience ONE OR MORE of these 3 events (hospitalization, death, or COVID-19-related MAV) occurring from randomization through Day 29 will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with at least 1 AE will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study intervention due to an AE will be presented.
Percentage of participants who had undetectable SARS-CoV-2 in baseline NP swabs and developed COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14 were reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The percentage of participants who were hospitalized and/or died through Day 29 is presented. Hospitalization (all cause) is defined as at least 24 hours of acute care in a hospital or similar acute care facility. Death was due to any cause. Any participants with an unknown survival status at Day 29 were treated as failure. The analysis in Part 2 was based on all participants enrolled by the pre-specified futility/early efficacy analysis and was used for demonstration of superiority to placebo for the primary efficacy outcome measure.
The number of participants with at least 1 AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants who discontinued study intervention due to an AE is presented. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
| Arm | Type | Description |
|---|---|---|
| Molnupiravir | EXPERIMENTAL | Participants will receive 800 mg molnupiravir orally every 12 hours for 5 days (a total of 10 consecutive doses) |
| Placebo | PLACEBO_COMPARATOR | Participants will receive molnupiravir-matching placebo orally every 12 hours for 5 days (a total of 10 consecutive doses) |
| Part 1: Molnupiravir 200 mg | EXPERIMENTAL | 200 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| Part 1: Molnupiravir 400 mg | EXPERIMENTAL | 400 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| Part 1: Molnupiravir 800 mg | EXPERIMENTAL | 800 mg molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| Part 1: Placebo | PLACEBO_COMPARATOR | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| Part 2: Molnupiravir 800 mg | EXPERIMENTAL | 800 mg Molnupiravir (dose to be selected) administered orally every 12 hours for 5 days (10 doses total) |
| Part 2: Placebo | PLACEBO_COMPARATOR | Placebo matching molnupiravir administered orally every 12 hours for 5 days (10 doses total) |
| Name | Type | Description |
|---|---|---|
| Molnupiravir | DRUG | Molnupiravir administered orally as two 400 mg film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses) |
| Placebo | DRUG | Molnupiravir-matching placebo administered orally as two film-coated tablets every 12 hours for 5 days (a total of 10 consecutive doses) |
Inclusion Criteria The main inclusion criteria include but are not limited to the following: * Is an individual of any sex/gender, ≥18 years of age * Has documentation of SARS-CoV-2 infection with sample collection ≤4 days prior to randomization * Has initial onset of signs/symptoms attributable t...