Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)

Phase 3 Completed 2441 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of the study is to assess if the study medication (molnupiravir, MK-4482) will prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who live with someone with confirmed COVID-19 infection. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants will receive molnupiravir twice daily by mouth and the other half will receive a placebo. The primary objectives of the study are to determine if molnupiravir prevents symptomatic COVID-19 disease and to evaluate its safety and tolerability. All participants who develop COVID-19 during the study are still eligible for any COVID-19 treatment recommended by their doctor.

Timeline

Start: 2021-08-11
Primary completion: 2022-11-16
Completion: 2022-11-16

Outcome

Missed primary endpoint

paper Molnupiravir was well-tolerated but did not meet the prespecified superiority criterion PMID 37690669 ↗

registry analysis (superiority test); Molnupiravir vs Placebo; p = 0.0848; Confidence Interval -2 (95% CI -5 to 0.9); Miettinen & Nurminen method NCT04939428 ↗

release “LAGEVRIO™ (molnupiravir) did not demonstrate a statistically significant reduction in the risk of COVID-19 following household exposure to another individual with COVID-19.” merck.com ↗

Publications

Results Alpizar SA, Accini J, Anderson DC, Eysa B, Medina-Pinon I, Ohmagari N, Ostrovskyy MM, Aggrey-Amable A, Beck K, Byrne D, Grayson S, Hwang PMT, Lonchar JD, Strizki J, Xu Y, Paschke A, De Anda CS, Sears PS; MOVe-AHEAD study group. Molnupiravir for intra-household prevention of COVID-19: The MOVe-AHEAD randomized, placebo-controlled trial. J Infect. 2023 Nov;87(5):392-402. doi: 10.1016/j.jinf.2023.08.016. Epub 2023 Sep 9.

Drugs

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