{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["76(3)"],"submitter":["Golan Y"],"funding":["Appili Therapeutics, Inc."],"pubmed_abstract":["<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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%).<h4>Conclusions</h4>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).<h4>Clinical trials registration</h4>NCT04600895."],"journal":["Clinical infectious diseases : an official publication of the Infectious Diseases Society of America"],"pagination":["e10-e17"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9494366"],"repository":["biostudies-literature"],"pubmed_title":["Favipiravir in Patients With Early Mild-to-moderate Coronavirus Disease 2019 (COVID-19): A Randomized Controlled Trial."],"pmcid":["PMC9494366"],"pubmed_authors":["Gonzales-Rojas Y","Woolson R","Hanabergh R","Balboni A","Golan Y","Lopez R","Finberg R","Cilla D","Campos JAS"],"additional_accession":[]},"is_claimable":false,"name":"Favipiravir in Patients With Early Mild-to-moderate Coronavirus Disease 2019 (COVID-19): A Randomized Controlled Trial.","description":"<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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%).<h4>Conclusions</h4>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).<h4>Clinical trials registration</h4>NCT04600895.","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Feb","modification":"2026-05-28T20:54:28.799Z","creation":"2025-02-19T03:57:44.076Z"},"accession":"S-EPMC9494366","cross_references":{"pubmed":["36065065"],"doi":["10.1093/cid/ciac712"]}}