Molnupiravir versus favipiravir in at-risk outpatients with COVID-19: A randomized controlled trial in Thailand.

Autor:	Salvadori N; AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand; Department of Statistics, Faculty of Science, Chiang Mai University, Chiang Mai, Thailand. Electronic address: nicolas.s@cmu.ac.th., Jourdain G; AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand., Krittayaphong R; Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand., Siripongboonsitti T; Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand., Kongsaengdao S; Rajavithi Hospital, Bangkok, Thailand., Atipornwanich K; Rajavithi Hospital, Bangkok, Thailand., Sakulkonkij P; Lampang Hospital, Lampang, Thailand., Angkasekwinai N; Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand., Sirijatuphat R; Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand., Chusri S; Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand., Mekavuthikul T; Samutsakhon Hospital, Samut Sakhon, Thailand., Apisarnthanarak A; Thammasat University Hospital, Pathum Thani, Thailand., Srichatrapimuk S; Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Samut Prakan, Thailand., Sungkanuparph S; Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Samut Prakan, Thailand., Kirdlarp S; Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Samut Prakan, Thailand., Phongnarudech T; Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Samut Prakan, Thailand., Sangsawang S; Health Promotion Center Region 1, Chiang Mai, Thailand., Napinkul P; Mahasarakham Hospital, Maha Sarakham, Thailand., Achalapong J; Chiangrai Prachanukroh Hospital, Chiang Rai, Thailand., Khusuwan S; Chiangrai Prachanukroh Hospital, Chiang Rai, Thailand., Pratipanawat P; Kalasin Hospital, Kalasin, Thailand., Nookeu P; Kalasin Hospital, Kalasin, Thailand., Danpipat N; Samutprakarn Hospital, Samut Prakan, Thailand., Leethong P; Samutprakarn Hospital, Samut Prakan, Thailand., Hanvoravongchai P; National Health Foundation, Bangkok, Thailand., Sukrakanchana PO; AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand., Auewarakul P; Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
Jazyk:	angličtina
Zdroj:	International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases [Int J Infect Dis] 2024 Jun; Vol. 143, pp. 107021. Date of Electronic Publication: 2024 Mar 30.
DOI:	10.1016/j.ijid.2024.107021
Abstrakt:	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.)
Databáze:	MEDLINE
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