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0 0.5 1 1.5 2+ ICU admission -619% Improvement Relative Risk Hospitalization -219% Time to clinical improvem.. -12% Time to viral clearance -15% primary Favipiravir  Bosaeed et al.  EARLY TREATMENT  DB RCT Is early treatment with favipiravir beneficial for COVID-19? Double-blind RCT 231 patients in Saudi Arabia (Jul 2020 - Aug 2021) Higher ICU admission (p=0.11) and hospitalization (p=0.16), not sig. Bosaeed et al., Clinical Microbiology .., Jan 2022 Favors favipiravir Favors control

Efficacy of favipiravir in adults with mild COVID-19: a randomized, double-blind, multicenter, placebo-controlled trial clinical trial

Bosaeed et al., Clinical Microbiology and Infection, doi:10.1016/j.cmi.2021.12.026, NCT04464408
Jan 2022  
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RCT with 112 favipiravir and 119 control patients showing no significant differences in outcomes. Viral clearance and clinical recovery for patients treated within 48 hours was better than those treated later. NCT04464408 (history).
risk of ICU admission, 618.8% higher, RR 7.19, p = 0.11, treatment 3 of 112 (2.7%), control 0 of 119 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of hospitalization, 218.8% higher, RR 3.19, p = 0.16, treatment 6 of 112 (5.4%), control 2 of 119 (1.7%).
time to clinical improvement, 11.9% higher, HR 1.12, p = 0.51, treatment 112, control 119, adjusted per study, inverted to make HR<1 favor treatment.
time to viral clearance, 14.9% higher, HR 1.15, p = 0.51, treatment 112, control 119, adjusted per study, inverted to make HR<1 favor treatment, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Bosaeed et al., 11 Jan 2022, Double Blind Randomized Controlled Trial, Saudi Arabia, peer-reviewed, 31 authors, study period 23 July, 2020 - 4 August, 2021, average treatment delay 3.0 days, trial NCT04464408 (history).
This PaperFavipiravirAll
Efficacy of favipiravir in adults with mild COVID-19: a randomized, double-blind, multicentre, placebo-controlled clinical trial
Mohammad Bosaeed, Ahmad Alharbi, Ebrahim Mahmoud, Sanaa Alrehily, Mohannad Bahlaq, Zied Gaifer, Hanan Alturkistani, Khaled Alhagan, Saad Alshahrani, Ali Tolbah, Abrar Musattat, Maha Alanazi, Raniah Jaha, Khizra Sultana, Hajar Alqahtani, Kholoud Al Aamer, Saud Jaser, Abdulrahman Alsaedy, Ayoub Ahmad, Mohammed Abalkhail, Sameera Aljohani, Sultan Majed Al Jeraisy, Sultan Almaziad, Nahlah Albaalharith, Khaled Alabdulkareem, Abdulmajeed Alshowair, Naif Khalaf Alharbi, Fahad Alrabiah, Majid Alshamrani, Omar Aldibasi, Ahmed Alaskar
Clinical Microbiology and Infection, doi:10.1016/j.cmi.2021.12.026
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
clinical/microbiological benefits of re-purposing antiviral therapy, particularly favipiravir, for SARS-CoV-2 infections. In conclusion, this randomized double-blinded placebo-controlled clinical trial found no clinical/virological benefit in treating mild COVID-19 patients with favipiravir. The trial result may influence decisions to remove favipiravir from national protocols for COVID-19 treatment. Transparency declaration All authors declare no conflict of interests. Author Contributions: Bosaeed M, Alharbi A, Mahmoud E, and Abalkhail M jointly formed the study concept and design,. All authors critically revised the report and approved the final version to be submitted for publication. The corresponding author confirms that he had full access to all the data in the study and had final responsibility for the decision to submit for publication Funding: This work was supported by King Abdullah International Medical Research Center, Saudi Arabia. Protocol No.RC20/220/R. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. All the authors have full access to all the data in the study and had final responsibility for the decision to submit for publication. The study Statistical Analysis Plan is available with this publication as part of the supplementary material. Individual participant data are..
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Hemoglobin, median (IQR)
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Oboho, Reed, Leon, Rothrock, Aragon et al., 1341The benefit of early influenza antiviral treatment of pregnant women hospitalized with laboratory-confirmed influenza, Open Forum Infectious Diseases
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Who Director, General's opening remarks at the media briefing on COVID-19 -11
Who, None
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