Evidence map›Paper›PMID 35446944›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

Favipiravir for Treatment of Outpatients With Asymptomatic or Uncomplicated Coronavirus Disease 2019: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial.

Marisa Holubar, Aruna Subramanian, Natasha Purington, Haley Hedlin, Bryan Bunning, Katharine S Walter, Hector Bonilla, Athanasia Boumis, Michael Chen, Kimberly Clinton and 16 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04346628 (A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild or Asymptomatic COVID-19), which is not on this map. Cited by 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 pooled it
4.3field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04346628 phase2completednot on this map

A Phase 2 Randomized, Double Blinded, Placebo Controlled Study of Oral Favipiravir Compared to Standard Supportive Care in Subjects With Mild or Asymptomatic COVID-19

TypeinterventionalSponsorStanford UniversityRan2020 to 2021Enrolled149ConditionsSars-CoV2, COVID-19ArmsFavipiravir, Placebo, Standard of care treatment
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 4 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Favipiravir for treating COVID-19.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Pooled it
  4. The efficacy and adverse effects of favipiravir on patients with COVID-19: A systematic review and meta-analysis of published clinical trials and observational studies.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2022
    Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Antivirals in COVID-19: A Focus on Pediatric Cardiac Patients.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2025
    Review
  11. Article
  12. Article
  13. Adverse drug reactions associated with COVID-19 management.Naunyn-Schmiedeberg's archives of pharmacology · 2024
    Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 3 institutions in 1 country.

Marisa HolubarDivision of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.ORCID 0000-0002-7585-1809
Aruna SubramanianDivision of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
Natasha PuringtonQuantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, California, USA.
Haley HedlinQuantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, California, USA.
Bryan BunningQuantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, California, USA.
Katharine S WalterDivision of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
Hector BonillaDivision of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
Athanasia BoumisStanford Center for Clinical Research, Stanford University, Stanford, California, USA.
Michael ChenStanford Solutions, Stanford University School of Medicine, Stanford, California, USA.
Kimberly ClintonStanford Center for Clinical Research, Stanford University, Stanford, California, USA.
Liisa DewhurstStanford Center for Clinical Research, Stanford University, Stanford, California, USA.
Carol EpsteinCarol L. Epstein MD Consulting LLC, Wellington, Florida, USA.
Prasanna JagannathanDivision of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.ORCID 0000-0001-6305-758X
Richard H KaszynskiStanford Solutions, Stanford University School of Medicine, Stanford, California, USA.
Lori PanuStanford Center for Clinical Research, Stanford University, Stanford, California, USA.
Julie ParsonnetDivision of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
Elizabeth L PonderStanford ChEM-H, Stanford University, Stanford, California, USA.
Orlando QuinteroDivision of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
Elizabeth SeftonStanford ChEM-H, Stanford University, Stanford, California, USA.
Upinder SinghDivision of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
Luke SoberanisStanford Center for Clinical Research, Stanford University, Stanford, California, USA.
Henry TruongMariner Advanced Pharmacy Corporation, San Mateo, California, USA.
Jason R AndrewsDivision of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California, USA.
Manisha DesaiQuantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, California, USA.
Chaitan KhoslaStanford ChEM-H, Stanford University, Stanford, California, USA.
Yvonne MaldonadoDepartment of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, California, USA.
Stanford University · USCenter for Clinical Research (United States) · USAdvanced Pharma · US

Funding

Stanford Center for Clinical & Translational Education and Research (Spectrum)UL1TR003142 · NCATS · STANFORD UNIVERSITY · PI O'HARA, RUTH M · 2019 to 2023
$45.0M
Stanford TRANSFORM I2T ProgramR25AI147369 · NIAID · STANFORD UNIVERSITY · PI CHERTOW, GLENN MATTHEW, SINGH, UPINDER · 2019 to 2023
$1.8M
NCATS NIH HHS UL1 TR003142NIAID NIH HHS R25 AI147369
6 · The paper itself

Abstract

backgroundFavipiravir, 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.

methodsWe 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.

resultsWe 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.

conclusionsOur 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.

Indexed as

COVID-19 Drug TreatmentAdultAmidesAntiviral AgentsDouble-Blind MethodFemaleHumansMaleOutpatientsPyrazinesSARS-CoV-2Treatment OutcomeAmidesAntiviral AgentsfavipiravirPyrazinesclinical trialCOVID-19favipiravirSARS-CoV-2

Identifiers

PMID35446944
PMCPMC9047233
OpenAlexW4226074581

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.