Your browser doesn't support javascript.
Favipiravir for Treatment of Outpatients With Asymptomatic or Uncomplicated Coronavirus Disease 2019: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial.
Holubar, Marisa; Subramanian, Aruna; Purington, Natasha; Hedlin, Haley; Bunning, Bryan; Walter, Katharine S; Bonilla, Hector; Boumis, Athanasia; Chen, Michael; Clinton, Kimberly; Dewhurst, Liisa; Epstein, Carol; Jagannathan, Prasanna; Kaszynski, Richard H; Panu, Lori; Parsonnet, Julie; Ponder, Elizabeth L; Quintero, Orlando; Sefton, Elizabeth; Singh, Upinder; Soberanis, Luke; Truong, Henry; Andrews, Jason R; Desai, Manisha; Khosla, Chaitan; Maldonado, Yvonne.
  • Holubar M; Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
  • Subramanian A; Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
  • Purington N; Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, California, USA.
  • Hedlin H; Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, California, USA.
  • Bunning B; Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, California, USA.
  • Walter KS; Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
  • Bonilla H; Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
  • Boumis A; Stanford Center for Clinical Research, Stanford University, Stanford, California, USA.
  • Chen M; Stanford Solutions, Stanford University School of Medicine, Stanford, California, USA.
  • Clinton K; Stanford Center for Clinical Research, Stanford University, Stanford, California, USA.
  • Dewhurst L; Stanford Center for Clinical Research, Stanford University, Stanford, California, USA.
  • Epstein C; Carol L. Epstein MD Consulting LLC, Wellington, Florida, USA.
  • Jagannathan P; Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
  • Kaszynski RH; Department of Microbiology and Immunology, Stanford University School of Medicine, Stanford, California, USA.
  • Panu L; Stanford Solutions, Stanford University School of Medicine, Stanford, California, USA.
  • Parsonnet J; Stanford Center for Clinical Research, Stanford University, Stanford, California, USA.
  • Ponder EL; Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
  • Quintero O; Department of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, California, USA.
  • Sefton E; Stanford ChEM-H, Stanford University, Stanford, California, USA.
  • Singh U; Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
  • Soberanis L; Stanford ChEM-H, Stanford University, Stanford, California, USA.
  • Truong H; Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
  • Andrews JR; Department of Microbiology and Immunology, Stanford University School of Medicine, Stanford, California, USA.
  • Desai M; Stanford Center for Clinical Research, Stanford University, Stanford, California, USA.
  • Khosla C; Mariner Advanced Pharmacy Corporation, San Mateo, California, USA.
  • Maldonado Y; Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
Clin Infect Dis ; 75(11): 1883-1892, 2022 Nov 30.
Article in English | MEDLINE | ID: covidwho-2134991
ABSTRACT

BACKGROUND:

Favipiravir, an oral, RNA-dependent RNA polymerase inhibitor, has in vitro activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Despite limited data, favipiravir is administered to patients with coronavirus disease 2019 (COVID-19) in several countries.

METHODS:

We conducted a phase 2, double-blind, randomized controlled outpatient trial of favipiravir in asymptomatic or mildly symptomatic adults with a positive SARS-CoV-2 reverse-transcription polymerase chain reaction assay (RT-PCR) within 72 hours of enrollment. Participants were randomized to receive placebo or favipiravir (1800 mg twice daily [BID] day 1, 800 mg BID days 2-10). The primary outcome was SARS-CoV-2 shedding cessation in a modified intention-to-treat (mITT) cohort of participants with positive enrollment RT-PCRs. Using SARS-CoV-2 amplicon-based sequencing, we assessed favipiravir's impact on mutagenesis.

RESULTS:

We randomized 149 participants with 116 included in the mITT cohort. The participants' mean age was 43 years (standard deviation, 12.5 years) and 57 (49%) were women. We found no difference in time to shedding cessation overall (hazard ratio [HR], 0.76 favoring placebo [95% confidence interval {CI}, .48-1.20]) or in subgroups (age, sex, high-risk comorbidities, seropositivity, or symptom duration at enrollment). We detected no difference in time to symptom resolution (initial HR, 0.84 [95% CI, .54-1.29]; sustained HR, 0.87 [95% CI, .52-1.45]) and no difference in transition mutation accumulation in the viral genome during treatment.

CONCLUSIONS:

Our data do not support favipiravir at commonly used doses in outpatients with uncomplicated COVID-19. Further research is needed to ascertain if higher favipiravir doses are effective and safe for patients with COVID-19. CLINICAL TRIALS REGISTRATION NCT04346628.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Drug Treatment Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: Cid

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Drug Treatment Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male Language: English Journal: Clin Infect Dis Journal subject: Communicable Diseases Year: 2022 Document Type: Article Affiliation country: Cid