Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial.
COVID-19
Favipiravir
Hydroxychloroquine
Moderate-to-severe
SARS-CoV-2
Journal
Infectious diseases and therapy
ISSN: 2193-8229
Titre abrégé: Infect Dis Ther
Pays: New Zealand
ID NLM: 101634499
Informations de publication
Date de publication:
Dec 2021
Dec 2021
Historique:
received:
03
06
2021
accepted:
01
07
2021
pubmed:
29
7
2021
medline:
29
7
2021
entrez:
28
7
2021
Statut:
ppublish
Résumé
Antiviral drugs have shown limited effectiveness in treating patients with coronavirus disease 2019 (COVID-19). We aimed to assess the effects of a favipiravir and hydroxychloroquine combination on treating moderate-to-severe COVID-19 patients. An investigator-initiated, multicenter, open-label, randomized trial at nine hospitals. Eligible patients were adults with moderate-to-severe COVID-19 defined as oxygen saturation (SaO From May 2020 to Jan 2021, 254 patients were enrolled; 129 were assigned to standard of care and 125 to the treatment. The mean age was 52 (± 13) years, and 103 (41%) were women. At randomization, six patients were on invasive mechanical ventilation, 229 (90.15%) were requiring supplemental oxygen only (with or without non-invasive ventilation), and 19 (7.48%) were receiving neither. The time to clinical improvement was not significantly different between the groups: median of 9 days in the treatment group and 7 days in the control group (HR: 0.845; 95% CI 0.617-1.157; p-value = 0.29). The 28-day mortality was not significantly different between the groups (7.63% treatment) vs. (10.32% control); p-value = 0.45. The most prevalent adverse events were headache, elevation in ALT, and the prolonged QTc interval in the treatment group. The combination of favipiravir and hydroxychloroquine did not result in a statistically significant clinical benefit in patients with moderate-to-severe COVID-19. ClinicalTrials.gov (NCT04392973).
Identifiants
pubmed: 34319552
doi: 10.1007/s40121-021-00496-6
pii: 10.1007/s40121-021-00496-6
pmc: PMC8316887
doi:
Banques de données
ClinicalTrials.gov
['NCT04392973']
Types de publication
Journal Article
Langues
eng
Pagination
2291-2307Subventions
Organisme : King Abdullah International Medical Research Center
ID : RC20/174/R
Informations de copyright
© 2021. The Author(s).
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