Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial

Autor:	Abdullatif Alarfaj, Manar Almaghaslah, Athari Alotaibi, Mohammad Bosaeed, Majed Al-Jeraisy, Yaseen M. Arabi, Hassan Almarhabi, Abderrezak Bouchama, Abdulmajid Al Arfaj, Mohammed Alzahrani, Abdulrahman Alsaedy, Majid Alshamrani, Omar Aldibasi, Malak Alharbi, Hajar Alqahtani, Badriah M. Almutairi, Khalid Ghalilah, Abdullah Bawazir, Nasser Alqahtani, Abdulhakeem O. Althaqafi, Nawaf M. Alyahya, Hawra Albayat, Sameera M. Al Johani, Ahmad Alaskar, Ebrahim Mahmoud, Jumana AlJishi, Faisal M. Alharbi, Hadeel Altayib, Saud AlEisa, Ahmad Alharbi
Rok vydání:	2021
Předmět:	Microbiology (medical) medicine.medical_specialty Randomization Combination therapy medicine.medical_treatment Population Favipiravir law.invention Randomized controlled trial law Internal medicine Medicine education Adverse effect Moderate-to-severe Original Research Mechanical ventilation education.field_of_study SARS-CoV-2 business.industry COVID-19 Hydroxychloroquine Infectious Diseases business medicine.drug
Zdroj:	Infectious Diseases and Therapy
ISSN:	2193-6382 2193-8229 0439-2973
Popis:	Introduction 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. Methods 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 (SaO2) of ≤ 94% while breathing ambient air or significant clinical symptoms with chest x-ray changes requiring hospital admission. Randomization was in a 1:1 ratio to receive standard care (control group) or standard care plus favipiravir and hydroxychloroquine. The primary outcome was time to clinical improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital within 14 days. Analyses were done in an intention-to-treat population. Results 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. Conclusion The combination of favipiravir and hydroxychloroquine did not result in a statistically significant clinical benefit in patients with moderate-to-severe COVID-19. Clinical Trial Registration ClinicalTrials.gov (NCT04392973). Supplementary Information The online version contains supplementary material available at 10.1007/s40121-021-00496-6.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cc6d88b198d3a07df0676267abc18f8b https://doi.org/10.1007/s40121-021-00496-6 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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