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Virologic Outcomes with Molnupiravir in Non-hospitalized Adult Patients with COVID-19 from the Randomized, Placebo-Controlled MOVe-OUT Trial

Strizki et al., Infectious Diseases and Therapy, doi:10.1007/s40121-023-00891-1, MOVe-OUT, NCT04575597
Nov 2023  
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Virological outcomes for the MOVe-OUT trial. Results are shown with the main paper Jayk Bernal.
Concerns have been raised that the mutagenic mechanism of action may create dangerous variants or cause cancer Chamod, Hadj Hassine, Huntsman, Marikawa, Swanstrom, Waters, Zhou, Zibat. Multiple analyses have identified variants potentially created by molnupiravir Fountain-Jones, Kosakovsky Pond, Sanderson,
Strizki et al., 23 Nov 2023, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, 10 authors, study period May 2021 - November 2021, average treatment delay 4.0 days, trial NCT04575597 (history) (MOVe-OUT). Contact:
This PaperMolnupiravirAll
Virologic Outcomes with Molnupiravir in Non-hospitalized Adult Patients with COVID-19 from the Randomized, Placebo-Controlled MOVe-OUT Trial
Julie M Strizki, Jay A Grobler, Nicholas Murgolo, Arthur Fridman, Matthew G Johnson, Jiejun Du, Patricia Carmelitano, Michelle L Brown, Amanda Paschke, Carisa De Anda
Infectious Diseases and Therapy, doi:10.1007/s40121-023-00891-1
Introduction: The randomized, placebo-controlled, double-blind MOVe-OUT trial demonstrated molnupiravir (800 mg every 12 h for 5 days) as safe and effective for outpatient treatment of mild-to-moderate COVID-19, significantly reducing the risk of hospitalization/ death in high-risk adults. At the time of that report, virologic assessments from the trial were partially incomplete as a result of their timeintensive nature. Here we present final results from all prespecified virology endpoints in MOVe-OUT based on the full trial dataset.
Supplementary Information The online version contains supplementary material available at https:// MSD), at the time the study was conducted. Jiejun Du is currently an employee of Moderna, and Jay A. Grobler is currently an employee of Pfizer Inc. Ethical Approval. Our company's approach to the conduct of clinical trials is in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and the applicable regulatory requirement(s). The trial was conducted in accordance with principles of Good Clinical Practice and was approved by the appropriate institutional Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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