Molnupiravir for intra-household prevention of COVID-19: The MOVe-AHEAD randomized, placebo-controlled trial - 13/10/23
, Jose Accini b , Duane C. Anderson c , Basem Eysa d , Isaí Medina-Piñón e , Norio Ohmagari f , Mykola M. Ostrovskyy g , Angela Aggrey-Amable h, Karen Beck h, Dana Byrne h, Staci Grayson h, Peggy M.T. Hwang h, Julia D. Lonchar h, Julie Strizki h, Yayun Xu h, Amanda Paschke h, Carisa S. De Anda h, Pamela S. Sears h, ⁎ on behalf of the MOVe-AHEAD study group
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Summary |
Objectives |
To evaluate the efficacy and safety of molnupiravir for intra-household post-exposure prophylaxis (PEP) of COVID-19.
Methods |
MOVe-AHEAD was a randomized, controlled, double-blind, phase 3 trial comparing molnupiravir (800 mg twice daily for 5 days) with placebo. Eligible participants were adult, unvaccinated, asymptomatic household contacts of patients with laboratory-confirmed COVID-19. The primary efficacy endpoint was the incidence of COVID-19 through day 14 in modified intention-to-treat (MITT) participants (those who received ≥1 dose of study intervention) without detectable SARS-CoV-2 at baseline, termed the MITT-VN population. Superiority of molnupiravir was prespecified as a stratified one-sided p-value of <0.0249 for the treatment difference in this endpoint.
Results |
The MITT population comprised 763 participants randomized to molnupiravir and 764 to placebo; 83.6% had anti-SARS-CoV-2 antibodies at baseline. In the MITT-VN population, COVID-19 rates through day 14 were 6.5% with molnupiravir and 8.5% with placebo (one-sided p-value: 0.0848). In the molnupiravir arm, 25/35 of confirmed COVID-19 events (71.4%) occurred after completion of treatment (versus 17/49 [34.7%] for placebo). Adverse event rates were low and similar between molnupiravir and placebo.
Conclusions |
Molnupiravir was well-tolerated but did not meet the prespecified superiority criterion, possibly influenced in part by the high pre-existing immunity in the trial population.
Le texte complet de cet article est disponible en PDF.Graphical Abstract |
Highlights |
• | Phase 3 trial evaluating molnupiravir for post-exposure prophylaxis of COVID-19. |
• | About 84% of the trial population had anti-SARS-CoV-2 antibodies at baseline. |
• | Day 14 COVID-19 rates (molnupiravir 6.5%, placebo 8.5%) were similar between arms. |
• | Onset of COVID-19 was mostly after the end of therapy in the molnupiravir arm. |
• | Molnupiravir was well tolerated but did not meet the superiority criterion. |
Keywords : Antiviral, Chemoprevention, Clinical trials, Post-exposure prevention, Randomized, SARS-CoV-2
Plan
| ☆ | ClinicalTrials.gov NCT 04939428. |
Vol 87 - N° 5
P. 392-402 - novembre 2023 Retour au numéro
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