Randomized controlled trial of favipiravir, hydroxychloroquine, and standard care in patients with mild/moderate COVID-19 disease

• Published in: Scientific reports Vol. 12; no. 1; p. 4925
• Main Authors: AlQahtani, Manaf, Kumar, Nitya, Aljawder, Dhuha, Abdulrahman, Abdulkarim, Mohamed, Mohammed Wael, Alnashaba, Fatema, Fayyad, Mohammed Abu, Alshaikh, Faisal, Alsahaf, Fatima, Saeed, Sawsan, Almahroos, Amal, Abdulrahim, Zainab, Otoom, Sameer, Atkin, Stephen L.
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 23-03-2022; Nature Publishing Group; Nature Portfolio
• Subjects: Antiviral activity; Clinical trials; Coronaviruses; COVID-19; Humanities and Social Sciences; Hydroxychloroquine; Influenza; Medical treatment; multidisciplinary; NCT; NCT04387760; Patients; Registration; Science; Science (multidisciplinary); Severe acute respiratory syndrome coronavirus 2; Uric acid; Vector-borne diseases; West Nile virus
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-022-08794-w

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.