Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)

Phase 2/3 Terminated 304 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the rate of sustained recovery through Day 29.

Timeline

Start: 2020-10-19
Primary completion: 2021-08-11
Completion: 2021-08-11

Outcome

Missed primary endpoint

Stopped (Business): “Business reasons”

registry analysis (superiority test); Part 1: Molnupiravir 200 mg vs Part 1: Placebo; p = 0.5620; Hazard Ratio (HR) 0.99 (95% CI 0.68 to 1.45); Log Rank NCT04575584 ↗

registry analysis (superiority test); Part 1: Molnupiravir 400 mg vs Part 1: Placebo; p = 0.3145; Hazard Ratio (HR) 1.13 (95% CI 0.78 to 1.65); Log Rank NCT04575584 ↗

registry analysis (superiority test); Part 1: Molnupiravir 800 mg vs Part 1: Placebo; p = 0.4894; Hazard Ratio (HR) 1.01 (95% CI 0.69 to 1.47); Log Rank NCT04575584 ↗

Publications

Results Arribas JR, Bhagani S, Lobo SM, Khaertynova I, Mateu L, Fishchuk R, Park WY, Hussein K, Kim SW, Ghosn J, Brown ML, Zhang Y, Gao W, Assaid C, Grobler JA, Strizki J, Vesnesky M, Paschke A, Butterton JR, De Anda C. Randomized Trial of Molnupiravir or Placebo in Patients Hospitalized with Covid-19. NEJM Evid. 2022 Feb;1(2):EVIDoa2100044. doi: 10.1056/EVIDoa2100044. Epub 2021 Dec 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Molnupiravir	Small molecule	200 mg	Oral
Subject	Molnupiravir	Small molecule	400 mg	Oral
Subject	Molnupiravir	Small molecule	800 mg	Oral