Favipiravir for treatment of outpatients with asymptomatic or uncomplicated COVID-19: a double-blind randomized, placebo-controlled, phase 2 trial
Holubar et al.,
Favipiravir for treatment of outpatients with asymptomatic or uncomplicated COVID-19: a double-blind..,
Clinical Infectious Diseases, doi:10.1093/cid/ciac312 (date from earlier preprint)
Small RCT 116 mITT patients in the USA, 59 treated with favipiravir, showing no significant differences with treatment.
risk of hospitalization, 89.0% lower, RR 0.11, p = 0.06, treatment 0 of 75 (0.0%), control 4 of 74 (5.4%), NNT 18, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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risk of ER visit, 29.5% lower, RR 0.70, p = 0.56, treatment 5 of 75 (6.7%), control 7 of 74 (9.5%), NNT 36.
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risk of no recovery, 19.0% higher, RR 1.19, p = 0.43, treatment 65, control 70, inverted to make RR<1 favor treatment, initial resolution of symptoms.
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viral shedding, 31.6% higher, RR 1.32, p = 0.24, treatment 59, control 57, inverted to make RR<1 favor treatment, primary outcome.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Holubar et al., 24 Nov 2021, Double Blind Randomized Controlled Trial, USA, peer-reviewed, 26 authors, average treatment delay 5.0 days, conflicts of interest:
Pfizer, Gates Foundation, Gilead, Regeneron, Janssen.
Abstract: 2
a double-blind randomized, placebo-controlled, phase 2 trial
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Marisa Holubar MD,1 Aruna Subramanian MD,1 Natasha Purington PhD,2 Haley Hedlin PhD,2
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Bryan Bunning MS,2 Katharine S. Walter PhD,1 Hector Bonilla MD,1 Athanasia Boumis,3
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Michael Chen MD,4 Kimberly Clinton,3 Liisa Dewhurst,3 Carol Epstein MD,5 Prasanna
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Jagannathan MD,1,6 Richard H. Kaszynski MD,4 Lori Panu,3 Julie Parsonnet MD,1,7 Elizabeth L.
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Ponder PhD,8 Orlando Quintero MD,1 Elizabeth Sefton PhD,8 Upinder Singh MD,1,6 Luke
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Soberanis,3 Henry Truong PharmD,9 Jason R. Andrews MD,1 Manisha Desai PhD,2 Chaitan
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Khosla PhD,10,8 Yvonne Maldonado MD11,7
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Medicine, Stanford, CA, USA
Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of
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Division of Infectious Diseases and Geographic Medicine, Stanford University School of
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Favipiravir for treatment of outpatients with asymptomatic or uncomplicated COVID-19:
Medicine, Stanford University, Palo Alto, CA, USA
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Stanford Center for Clinical Research, Stanford University, Stanford, CA, USA
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Stanford Solutions, Stanford University School of Medicine, Stanford, CA 94305, USA
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Carol L. Epstein MD Consulting LLC, Wellington, FL, USA
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Department of Microbiology and Immunology, Stanford University School of Medicine,
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Stanford, CA, USA
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Department of Epidemiology and Population Health, Stanford University School of
Medicine, Stanford, CA, USA
Stanford ChEM-H, Stanford University, Stanford CA, USA
© The Author(s) 2022. Published by Oxford University Press on behalf of the Infectious Diseases Society of
America. This is an Open Access article distributed under the terms of the Creative Commons AttributionNonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits noncommercial reproduction and distribution of the work, in any medium, provided the original work is not altered or
transformed in any way, and that the work is properly cited. For commercial re-use, please contact
journals.permissions@oup.com
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Mariner Advanced Pharmacy Corp, San Mateo, California
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Departments of Chemistry and Chemical Engineering, Stanford University, Stanford,
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CA, USA
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Correspondence:
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Marisa Holubar, MD MS
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Clinical Associate Professor of Medicine
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Division of Infectious Diseases and Geographic Medicine
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Stanford University School of Medicine
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300 Pasteur Drive, Lane Building 145 Stanford, CA 94305 USA
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mholubar@stanford.edu
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Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA
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Background: Favipiravir is an oral, RNA-dependent RNA polymerase inhibitor with in vitro
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activity against SARS-CoV2. Despite limited data, favipiravir is administered to patients with
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COVID-19 in several countries.
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Methods: We conducted a phase 2 double-blind randomized controlled outpatient trial of
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favipiravir in asymptomatic or mildly symptomatic adults with a positive SARS-CoV2 RT-PCR
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within 72 hours of enrollment. Participants were randomized 1:1 to receive placebo or favipiravir
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(1800..
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