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

DOI record: { "DOI": "10.1038/s41598-022-08794-w", "ISSN": [ "2045-2322" ], "URL": "http://dx.doi.org/10.1038/s41598-022-08794-w", "abstract": "<jats:title>Abstract</jats:title><jats:p>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 &lt; 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 (<jats:italic>P</jats:italic> &lt; 0.03) and uric acid (<jats:italic>P</jats:italic> &lt; 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.</jats:p><jats:p>Clinical trials registration. NCT04387760. Registration date: 07/05/2020.</jats:p>", "alternative-id": [ "8794" ], "article-number": "4925", "assertion": [ { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Received", "name": "received", "order": 1, "value": "12 July 2021" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Accepted", "name": "accepted", "order": 2, "value": "7 February 2022" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "First Online", "name": "first_online", "order": 3, "value": "23 March 2022" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Change Date", "name": "change_date", "order": 4, "value": "26 September 2022" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Change Type", "name": "change_type", "order": 5, "value": "Correction" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Change Details", "name": 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