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    Favipiravir in patients with early mild-to-moderate COVID-19: a randomized controlled trial

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    Authors
    Golan, Yoav
    Campos, Jesus Abraham Simon
    Woolson, Rob
    Cilla, Donald
    Hanabergh, Rodolfo
    Gonzales-Rojas, Yaneicy
    Lopez, Reynaldo
    Finberg, Robert
    Balboni, Armand
    UMass Chan Affiliations
    Medicine
    Document Type
    Journal Article
    Publication Date
    2022-09-06
    Keywords
    COVID-19
    antiviral
    favipiravir
    progression
    treatment
    
    Metadata
    Show full item record
    Link to Full Text
    https://doi.org/10.1093/cid/ciac712
    Abstract
    Background: Despite vaccination, many remain vulnerable to COVID-19 and its complications. Oral antivirals to prevent COVID-19 progression are vital. Based upon 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% 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 three and two days, respectively. There was no difference in TT-SCR (median of 7 days for both groups; p = 0.80), COVID-19 progression [11 patients each (1.9% vs. 1.8%); p = 0.96], time to undetectable virus [median = 6 days, 95% CI (6-8) vs. 7 days, 95% CI (6-9)], or in undetectable virus by end of therapy (73.4% vs. 72.3%; p = 0.94). 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.
    Source
    Golan Y, Campos JAS, Woolson R, Cilla D, Hanabergh R, Gonzales-Rojas Y, Lopez R, Finberg R, Balboni A. Favipiravir in patients with early mild-to-moderate COVID-19: a randomized controlled trial. Clin Infect Dis. 2022 Sep 6:ciac712. doi: 10.1093/cid/ciac712. Epub ahead of print. PMID: 36065065; PMCID: PMC9494366.
    DOI
    10.1093/cid/ciac712
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/51213
    PubMed ID
    36065065
    Rights
    © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
    ae974a485f413a2113503eed53cd6c53
    10.1093/cid/ciac712
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