Favipiravir in the Treatment of Outpatient COVID-19: A Multicenter, Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
RCT 77 outpatients in Iran, showing increased hospitalization with treatment, without statistical significance. Favipiravir 1600mg daily for five days. 21% of favipiravir patients did not complete treatment.
risk of hospitalization, 105.3% higher, RR 2.05, p = 0.43, treatment 4 of 38 (10.5%), control 2 of 39 (5.1%), day 28.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Vaezi et al., 28 Jan 2023, Double Blind Randomized Controlled Trial, placebo-controlled, Iran, peer-reviewed, 6 authors, study period 5 December, 2020 - 31 March, 2021, trial
IRCT20171219037964N3.
Contact:
salahimehrdad@yahoo.com (corresponding author).
Abstract: Article
Favipiravir in the Treatment of Outpatient COVID-19: A
Multicenter, Randomized, Triple-Blind, Placebo-Controlled
Clinical Trial
Atefeh Vaezi 1 , Mehrzad Salmasi 2 , Forogh Soltaninejad 3 , Mehrdad Salahi 4, *, Shaghayegh
Haghjooy Javanmard 5 and Babak Amra 3
1
2
3
4
5
*
Cancer Prevention Research Center, Isfahan University of Medical Sciences, Isfahan 8174673461, Iran
Department of Internal Medicine, School of Medicine, Isfahan University of Medical Sciences,
Isfahan 8174673461, Iran
Bamdad Respiratory and Sleep Research Center, Department of Internal Medicine, School of Medicine,
Isfahan University of Medical Sciences, Isfahan 8174673461, Iran
Department of Infectious Disease, School of Medicine, Isfahan University of Medical Sciences,
Isfahan 8174673461, Iran
Department of Physiology, Applied Physiology Research Center, Cardiovascular Research Institute,
Isfahan University of Medical Sciences, Isfahan 8174673461, Iran
Correspondence: salahimehrdad@yahoo.com
Highlights:
What are the main findings?
•
Favipiravir, an RNA-dependent RNA polymerase inhibitor, shows no benefit in preventing the
hospitalization of mild to moderate COVID-19 patients.
What is the implication of the main finding?
•
Citation: Vaezi, A.; Salmasi, M.;
Soltaninejad, F.; Salahi, M.;
Javanmard, S.H.; Amra, B.
Favipiravir in the Treatment of
Outpatient COVID-19: A Multicenter,
Randomized, Triple-Blind,
Placebo-Controlled Clinical Trial.
Adv. Respir. Med. 2023, 91, 18–25.
https://doi.org/10.3390/arm91010004
Received: 28 November 2022
Revised: 11 January 2023
Accepted: 20 January 2023
Published: 28 January 2023
Copyright: © 2023 by the authors.
Our results may inform decisions on the exclusion of Favipiravir from mild to moderate
COVID-19 treatment guidelines.
Abstract: Background: Finding effective outpatient treatments to prevent COVID-19 progression
and hospitalization is necessary and is helpful in managing limited hospital resources. Repurposing
previously existing treatments is highly desirable. In this study, we evaluate the efficacy of Favipiravir
in the prevention of hospitalization in symptomatic COVID-19 patients who were not eligible for
hospitalization. Methods: This study was a triple-blind randomized controlled trial conducted
between 5 December 2020 and 31 March 2021 in three outpatient centers in Isfahan, Iran. Patients
in the intervention group received Favipiravir 1600 mg daily for five days, and the control group
received a placebo. Our primary outcome was the proportion of hospitalized participants from day
0 to day 28. The outcome was assessed on days 3, 7, 14, 21, and 28 through phone calls. Results:
Seventy-seven patients were randomly allocated to Favipiravir and placebo groups. There was
no significant difference between groups considering baseline characteristics. During the study
period, 10.5% of patients in the Favipiravir group and 5.1% of patients in the placebo group were
hospitalized, but there was no significant difference between them (p-value = 0.3). No adverse event
was reported in the treatment group. Conclusions: Our study shows that Favipiravir did not reduce
the hospitalization rate of mild to moderate COVID-19 patients in outpatient settings.
Keywords: efficacy; Favipiravir; mild COVID-19; outpatient; SARS-CoV-2
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