1. Molnupiravir versus favipiravir in at-risk outpatients with COVID-19: A randomized controlled trial in Thailand.
- Author
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Salvadori N, Jourdain G, Krittayaphong R, Siripongboonsitti T, Kongsaengdao S, Atipornwanich K, Sakulkonkij P, Angkasekwinai N, Sirijatuphat R, Chusri S, Mekavuthikul T, Apisarnthanarak A, Srichatrapimuk S, Sungkanuparph S, Kirdlarp S, Phongnarudech T, Sangsawang S, Napinkul P, Achalapong J, Khusuwan S, Pratipanawat P, Nookeu P, Danpipat N, Leethong P, Hanvoravongchai P, Sukrakanchana PO, and Auewarakul P
- Subjects
- Humans, Male, Female, Thailand, Middle Aged, Adult, Cytidine therapeutic use, Cytidine adverse effects, Cytidine administration & dosage, Hydroxylamines therapeutic use, Hydroxylamines adverse effects, Hydroxylamines administration & dosage, Aged, Treatment Outcome, COVID-19, Outpatients, Amides therapeutic use, Pyrazines therapeutic use, Pyrazines adverse effects, Pyrazines administration & dosage, COVID-19 Drug Treatment, Antiviral Agents therapeutic use, Antiviral Agents adverse effects, Antiviral Agents administration & dosage, SARS-CoV-2, Cytidine analogs & derivatives
- Abstract
Objectives: Evaluate and compare the efficacy and safety of molnupiravir and favipiravir in outpatients with mild to moderate COVID-19 and at risk of severe COVID-19., Methods: In an open-label, parallel-group, multicenter trial in Thailand, participants with moderate COVID-19 and at least one factor associated with severe COVID-19 were randomly assigned 1:1 to receive oral molnupiravir or oral favipiravir (standard of care). Phone calls for remote symptom assessment were made on Days 6, 15, and 29. Participants with worsening symptoms were instructed to return to the hospital. The primary endpoint was pulmonary involvement by Day 29, as evidenced by ≥2 of the following: dyspnea, oxygen saturation <92% or imaging., Results: Nine hundred seventy-seven participants (487 molnupiravir, 490 favipiravir) were enrolled from 8 July 2022 to 19 January 2023. 98% had received ≥1 dose of COVID-19 vaccine and 83% ≥3 doses. By Day 29, pulmonary involvement occurred in 0% (0/483) in molnupiravir arm versus 1% (5/482) in favipiravir arm (-1.0%; Newcombe 95.2% CI: -2.4% to -0.0%; P = 0.021); all-cause death in 0% (0/483) and <1% (1/482); COVID-19 related hospitalization in <1% (1/483) and 1% (3/482); treatment-related adverse event in 1% (5/483) and 1% (4/486); and serious adverse event in 1% (4/483) and 1% (4/486)., Conclusions: Favipiravir and molnupiravir had a similar efficacy and safety profile. Whether either of the two reduced the risk of complications during the omicron era in this population with a low risk of pulmonary involvement and a high vaccine coverage remains unclear. There were no differences in any of the safety endpoints., Thai Clinical Trials Registry Id: TCTR20230111009., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2024
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