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Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial
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, multi...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8316887/ https://www.ncbi.nlm.nih.gov/pubmed/34319552 http://dx.doi.org/10.1007/s40121-021-00496-6 |
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author | Bosaeed, Mohammad Mahmoud, Ebrahim Alharbi, Ahmad Altayib, Hadeel Albayat, Hawra Alharbi, Faisal Ghalilah, Khalid Al Arfaj, Abdulmajid AlJishi, Jumana Alarfaj, Abdullatif Alqahtani, Hajar Almutairi, Badriah M. Almaghaslah, Manar Alyahya, Nawaf M. Bawazir, Abdullah AlEisa, Saud Alsaedy, Abdulrahman Bouchama, Abderrezak Alharbi, Malak AlShamrani, Majid Al Johani, Sameera Aljeraisy, Majed Alzahrani, Mohammed Althaqafi, Abdulhakeem O. Almarhabi, Hassan Alotaibi, Athari Alqahtani, Nasser Arabi, Yaseen M. Aldibasi, Omar S. Alaskar, Ahmad |
author_facet | Bosaeed, Mohammad Mahmoud, Ebrahim Alharbi, Ahmad Altayib, Hadeel Albayat, Hawra Alharbi, Faisal Ghalilah, Khalid Al Arfaj, Abdulmajid AlJishi, Jumana Alarfaj, Abdullatif Alqahtani, Hajar Almutairi, Badriah M. Almaghaslah, Manar Alyahya, Nawaf M. Bawazir, Abdullah AlEisa, Saud Alsaedy, Abdulrahman Bouchama, Abderrezak Alharbi, Malak AlShamrani, Majid Al Johani, Sameera Aljeraisy, Majed Alzahrani, Mohammed Althaqafi, Abdulhakeem O. Almarhabi, Hassan Alotaibi, Athari Alqahtani, Nasser Arabi, Yaseen M. Aldibasi, Omar S. Alaskar, Ahmad |
author_sort | Bosaeed, Mohammad |
collection | PubMed |
description | 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 (SaO(2)) 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. |
format | Online Article Text |
id | pubmed-8316887 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-83168872021-07-28 Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial Bosaeed, Mohammad Mahmoud, Ebrahim Alharbi, Ahmad Altayib, Hadeel Albayat, Hawra Alharbi, Faisal Ghalilah, Khalid Al Arfaj, Abdulmajid AlJishi, Jumana Alarfaj, Abdullatif Alqahtani, Hajar Almutairi, Badriah M. Almaghaslah, Manar Alyahya, Nawaf M. Bawazir, Abdullah AlEisa, Saud Alsaedy, Abdulrahman Bouchama, Abderrezak Alharbi, Malak AlShamrani, Majid Al Johani, Sameera Aljeraisy, Majed Alzahrani, Mohammed Althaqafi, Abdulhakeem O. Almarhabi, Hassan Alotaibi, Athari Alqahtani, Nasser Arabi, Yaseen M. Aldibasi, Omar S. Alaskar, Ahmad Infect Dis Ther Original Research 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 (SaO(2)) 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. Springer Healthcare 2021-07-28 2021-12 /pmc/articles/PMC8316887/ /pubmed/34319552 http://dx.doi.org/10.1007/s40121-021-00496-6 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Bosaeed, Mohammad Mahmoud, Ebrahim Alharbi, Ahmad Altayib, Hadeel Albayat, Hawra Alharbi, Faisal Ghalilah, Khalid Al Arfaj, Abdulmajid AlJishi, Jumana Alarfaj, Abdullatif Alqahtani, Hajar Almutairi, Badriah M. Almaghaslah, Manar Alyahya, Nawaf M. Bawazir, Abdullah AlEisa, Saud Alsaedy, Abdulrahman Bouchama, Abderrezak Alharbi, Malak AlShamrani, Majid Al Johani, Sameera Aljeraisy, Majed Alzahrani, Mohammed Althaqafi, Abdulhakeem O. Almarhabi, Hassan Alotaibi, Athari Alqahtani, Nasser Arabi, Yaseen M. Aldibasi, Omar S. Alaskar, Ahmad Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial |
title | Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial |
title_full | Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial |
title_fullStr | Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial |
title_full_unstemmed | Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial |
title_short | Favipiravir and Hydroxychloroquine Combination Therapy in Patients with Moderate to Severe COVID-19 (FACCT Trial): An Open-Label, Multicenter, Randomized, Controlled Trial |
title_sort | favipiravir and hydroxychloroquine combination therapy in patients with moderate to severe covid-19 (facct trial): an open-label, multicenter, randomized, controlled trial |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8316887/ https://www.ncbi.nlm.nih.gov/pubmed/34319552 http://dx.doi.org/10.1007/s40121-021-00496-6 |
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