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0 0.5 1 1.5 2+ Time to clinical improve.. 64% primary Improvement Relative Risk Clinical improvement 90% Mild pneumonia 43% Viral clearance -4% c19early.org/a Sirijatuphat et al. TCTR20200514001 Favipiravir RCT EARLY Is early treatment with favipiravir beneficial for COVID-19? RCT 93 patients in Thailand Faster improvement with favipiravir (p=0.00046) Sirijatuphat et al., medRxiv, doi:10.1101/2022.06.06.22275902 Favors favipiravir Favors control
Early Treatment of Favipiravir in COVID-19 Patients Without Pneumonia: A Multicentre, Open-Labelled, Randomized Control Study
Sirijatuphat et al., medRxiv, doi:10.1101/2022.06.06.22275902, TCTR20200514001
Sirijatuphat et al., Early Treatment of Favipiravir in COVID-19 Patients Without Pneumonia: A Multicentre, Open-Labelled,.., medRxiv, doi:10.1101/2022.06.06.22275902, TCTR20200514001
Jun 2022   Source   PDF  
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RCT 93 patients in Thailand showing significantly faster clinical improvement with favipiravir treatment. 1800mg favipiravir bid day 1, 800mg bid 5-14 days until PCR-.
time to clinical improvement, 63.9% lower, HR 0.36, p < 0.001, treatment 62, control 31, inverted to make HR<1 favor treatment, primary outcome.
clinical improvement, 89.9% lower, OR 0.10, p < 0.001, treatment 62, control 31, inverted to make OR<1 favor treatment, logistic regression, day 14, RR approximated with OR.
risk of mild pneumonia, 42.9% lower, RR 0.57, p = 0.25, treatment 8 of 62 (12.9%), control 7 of 31 (22.6%), NNT 10.
risk of no viral clearance, 4.2% higher, HR 1.04, p = 0.87, treatment 62, control 31, adjusted per study, inverted to make HR<1 favor treatment.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Sirijatuphat et al., 8 Jun 2022, Randomized Controlled Trial, Thailand, peer-reviewed, 9 authors, trial TCTR20200514001.
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Abstract: medRxiv preprint doi: https://doi.org/10.1101/2022.06.06.22275902; this version posted June 8, 2022. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 1 Early Treatment of Favipiravir in COVID-19 Patients Without Pneumonia: A Multicentre, 2 Open-Labelled, Randomized Control Study 3 Rujipas Sirijatuphata, Weerawat Manosuthib, Suvimol Niyomnaithamc,d, Andrew Owene, 4 Katherine K. Copelandf, Lantharita Charoenpongb, Manoch Rattanasompattikulg, Surakameth 5 Mahasirimongkolh, Kulkanya Chokephaibulkitd,i* 6 7 a 8 Thailand; bBamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, 9 Thailand; cDepartment of Pharmacology, Faculty of Medicine Siriraj Hospital, Mahidol 10 University, Thailand; dSiriraj Institute of Clinical Research (SICRES), Mahidol University, 11 Thailand; eInstitute of Systems, Molecular and Integrative Biology, University of Liverpool, 12 United Kingdom; fMahidol University International College, Salaya, Nakhon Pathom, Thailand; 13 g 14 Mahidol University, Thailand; hDivision of Genomic Medicine and Innovation Support, 15 Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand; iDepartment 16 of Paediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Medical Department, Golden Jubilee Medical Centre, Faculty of Medicine Siriraj Hospital, 17 18 *Corresponding author: Kulkanya Chokephaibulkit, MD, 19 2 Wanglang Road, Bangkoknoi, Bangkok 10700, Thailand 20 Tel: (+66) 2-4141899; Fax: (+66) 2-4128243, 21 E-mail: kulkanya.cho@mahidol.ac.th. NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2022.06.06.22275902; this version posted June 8, 2022. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 22 Abstract 23 We investigated Favipiravir (FPV) efficacy in mild cases of COVID-19 without pneumonia and 24 its effects towards viral clearance, clinical condition, and risk of COVID-19 pneumonia 25 development. PCR-confirmed SARS-CoV-2-infected patients without pneumonia were enrolled 26 (2:1) within 10 days of symptomatic onset into FPV and control arms. The former received 1800 27 mg FPV twice-daily (BID) on Day 1 and 800 mg BID 5-14 days thereafter until negative viral 28 detection, while the latter received supportive care only. The primary endpoint was time to clinical 29 improvement, which was defined by a reduced National Early Warning Score (NEWS) or score of 30 <1. 62 patients (41 female) comprised the FPV arm (median age: 32 years, median BMI: 22 kg/m²) 31 and 31 patients (19 female) comprised the control arm (median age: 28 years, median BMI: 22 32 kg/m². The median time to sustained clinical improvement by NEWS was 2 vs 14 days for FPV 33 and control arms respectively (adjusted hazard ratio (aHR) of 2.77, 95% CI 1.57-4.88, P <0.001). 34 The FPV arm also had significantly higher likelihoods of..
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