Royal College of Surgeons in Ireland
AlQahtani, NKumar_RCT_Favipiravir_Nature_SR_2022.pdf (1.16 MB)
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Randomized controlled trial of favipiravir, hydroxychloroquine, and standard care in patients with mild/moderate COVID-19 disease

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posted on 2022-12-08, 12:09 authored by Manaf AlQahtaniManaf AlQahtani, Nitya KumarNitya Kumar, Dhuha Aljawder, Abdulkarim Abdulrahman, Mohammed Wael Mohamed, Fatema Alnashaba, Mohammed Abu Fayyad, Faisal Alshaikh, Fatima Alsahaf, Sawsan Saeed, Amal Almahroos, Zainab Abdulrahim, Sameer Otoom, Stephen AtkinStephen Atkin
Favipiravir has antiviral activity against influenza, West Nile virus, and yellow fever virus and against flaviviruses. The objective of this pilot study was to compare three arms: favipiravir; hydroxychloroquine; standard care (no specific SARS-CoV-2 treatment) only, in symptomatic patients infected by SARS-CoV-2 in an open-labelled randomized clinical trial. The trial was registered with Bahrain National Taskforce for Combatting COVID-19 on the 7th of May 2020 (registration code: NCT04387760). 150 symptomatic patients with COVID-19 disease were randomized into one of three arms: favipiravir, hydroxychloroquine, or standard care only. The primary outcome was the clinical scale at the end of study follow up (day 14 or on discharge/death) based on a points scale. The secondary outcomes were viral clearance, biochemical parameter changes and mortality at 30-days. Baseline characteristics did not differ between groups. The proportion of patients who achieved a clinical scale < 2 did not differ between groups. The favipiravir-treated and hydroxychloroquine-treated group showed increased viral clearance (OR, 95%CI 2.38, 0.83-6.78, OR, 95%CI 2.15, 0.78-5.92, respectively) compared to standard care, but this was not significant. The biochemical profile did not differ between groups, except for the platelet count (P < 0.03) and uric acid (P < 0.004) that were higher with favipiravir-treatment. Primary or secondary outcome measures did not differ between favipiravir, hydroxychloroquine, and standard therapy for mild to moderate COVID-19 disease; therefore, whilst favipiravir therapy appeared safe with a trend to increased viral clearance, there was no superior therapeutic utility.Clinical trials registration.
NCT04387760. Registration date: 07/05/2020.


National Taskforce for combating the Coronavirus (COVID- 19), Ministry of Health Bahrain

Royal College of Surgeons in Ireland-Bahrain.



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Published Citation

AlQahtani M, et al. Randomized controlled trial of favipiravir, hydroxychloroquine, and standard care in patients with mild/moderate COVID-19 disease. Sci Rep. 2022;12(1):4925.

Publication Date

23 March 2022

PubMed ID



  • RCSI Bahrain


Springer Nature


  • Published Version (Version of Record)