Favipiravir in Patients With Early Mild-to-moderate Coronavirus Disease 2019 (COVID-19): A Randomized Controlled Trial
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Le résumé fourni par la source
BACKGROUND: Despite vaccination, many remain vulnerable to coronavirus disease 2019 (COVID-19) and its complications. Oral antivirals to prevent COVID-19 progression are vital. Based on perceived potency and clinical efficacy, favipiravir is widely used to treat COVID-19. Evidence from large randomized controlled trials (RCT) is lacking. METHODS: In this multicenter double-blinded placebo-controlled RCT, adults with early mild-to-moderate COVID-19 were 1:1 randomized to favipiravir or placebo. The study evaluated time to sustained clinical recovery (TT-SCR), COVID-19 progression, and cessation of viral shedding. RESULTS: Of 1187 analyzed patients across 40 centers, 83.3% were Hispanic, 89.0% unvaccinated, 70.3% severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seronegative, and 77.8% had risk factors for COVID-19 progression. The median time from symptom presentation and from positive test to randomization was 3 and 2 days, respectively. There was no difference in TT-SCR (median of 7 days for both groups; P = .80), COVID-19 progression [11 patients each (1.9% vs 1.8%); P = .96], time to undetectable virus (median = 6 days, 95% confidence interval [CI] [6-8] vs 7 days, 95% CI [6-9]), or in undetectable virus by end of therapy (73.4% vs 72.3%; P = .94). Outcomes were consistent across the analyzed sub-groups. Adverse events were observed in 13.8% and 14.8% of favipiravir-treated and placebo-treated subjects, respectively. Uric acid elevation was more frequent among favipiravir-treated subjects (19.9% vs 2.8%). CONCLUSIONS: Favipiravir was well tolerated but lacked efficacy in TT-SCR, progression to severe COVID-19, or cessation of viral shedding and should not be used to treat patients with COVID-19. (Supported by Appili Therapeutics). CLINICAL TRIALS REGISTRATION: NCT04600895.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Favipiravir in Patients With Early Mild-to-moderate Coronavirus Disease 2019 (COVID-19): A Randomized Controlled Trial
- Date Crossref
- 06/09/2022
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Tufts Medical Center pays non établi dans la noticeÉtablissement de santé
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Memorial Hospital Department of Medicine pays non établi dans la noticeÉtablissement de santé
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Kohler and Milstein Research S.A. de C.V. pays non établi dans la noticeInstitution
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Inc Rho pays non établi dans la noticeEntreprise
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Appili Therapeutics pays non établi dans la noticeInstitution
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Quality Professional Healthcare pays non établi dans la noticeInstitution
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Verus Clinical Research pays non établi dans la noticeÉtablissement de santé
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Bioresearch Institute LLC pays non établi dans la noticeStructure de recherche
Tufts Medical Center, Department of Medicine — Memorial Hospital et Kohler and Milstein Research S.A. de C.V., avec 5 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.