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.
Keywords: COVID-19, treatment, progression, antiviral, favipiravir
Contributor Information
Yoav Golan, Tufts Medical Center, Appili Therapeutics, Boston, MA, USA.
Jesus Abraham Simon Campos, Kohler & Milstein Research S.A. de C.V., Merida, Mexico.
Rob Woolson, Rho, Inc., Durham, NC, USA.
Donald Cilla, Appili Therapeutics, Waterford, VA, USA.
Rodolfo Hanabergh, Quality Professional Healthcare, Miami, FL, USA.
Yaneicy Gonzales-Rojas, Verus Clinical Research, Corp., Coconut Grove, FL, USA.
Reynaldo Lopez, Bioresearch Institute LLC, Hollywood, Florida, USA.
Robert Finberg, UMass Memorial Hospital, Worcester, MA, USA.
Armand Balboni, Appili Therapeutics, Inc., Waterford, VA, USA.
Supplementary Material
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