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Efficacy of Early Treatment with Favipiravir on Disease Progression among High Risk COVID-19 Patients: A Randomized, Open-Label Clinical Trial

Chuah et al., Clinical Infectious Diseases, doi:10.1093/cid/ciab962
Nov 2021  
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Mortality -1154% Improvement Relative Risk Ventilation -20% ICU admission -9% Favipiravir  Chuah et al.  LATE TREATMENT  RCT Is late treatment with favipiravir beneficial for COVID-19? RCT 500 patients in Malaysia (February - July 2021) Higher mortality with favipiravir (not stat. sig., p=0.08) c19early.org Chuah et al., Clinical Infectious Dise.., Nov 2021 Favorsfavipiravir Favorscontrol 0 0.5 1 1.5 2+
RCT 500 hospitalized patients in Malaysia, showing no significant differences with favipiravir treatment.
Potential risks of favipiravir include the creation of dangerous variants, and mutagenicity, carcinogenicity, teratogenicity, and embryotoxicity1-5.
risk of death, 1154.0% higher, RR 12.54, p = 0.08, treatment 5 of 250 (2.0%), control 0 of 250 (0.0%), odds ratio converted to relative risk, continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of mechanical ventilation, 19.5% higher, RR 1.20, p = 0.76, treatment 6 of 250 (2.4%), control 5 of 250 (2.0%), odds ratio converted to relative risk.
risk of ICU admission, 8.5% higher, RR 1.09, p = 0.84, treatment 13 of 250 (5.2%), control 12 of 250 (4.8%), odds ratio converted to relative risk.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Chuah et al., 19 Nov 2021, Randomized Controlled Trial, Malaysia, peer-reviewed, 18 authors, study period February 2021 - July 2021.
This PaperFavipiravirAll
Efficacy of Early Treatment with Favipiravir on Disease Progression among High Risk COVID-19 Patients: A Randomized, Open-Label Clinical Trial
Dr Chuan Huan, Chuah, Chow Ting Soo, Hor Chee Peng, Joo Thye, Cheng, Hong Bee, Ker, Heng Gee, Lee, Kok Soon, Tiang Koi, Ng, Abdul Suhaila, Wahab, Nurul Ashikin, Tee Tze Yuan, Su Miin, Ong, Chidambaram Suresh Kumar, Malaysian Favipiravir, Study Group
doi:10.1093/cid/ciab962/6432025
Role of favipiravir remains uncertain in COVID-19. Early treatment with five days oral favipiravir did not prevent disease progression from non-hypoxia to hypoxia in high-risk patients. No beneficial effects were observed in preventing mechanical ventilation, ICU admission, and in-hospital mortality.
A c c e p t e d M a n u s c r i p t 18 moderate to severe diseases. All the recruited patients had risk factors for disease progression and half had evidence of COVID-19 pneumonia. Up to 97.4% of subjects completed the study with outcomes available for evaluation. Patients in intervention group received adequate dosing and duration of favipiravir before the occurrence of clinical deterioration around 4.5 (8.72 ) days from the study enrolment. The use of disease-modifying therapies which could improve clinical outcomes were also equal in both groups. CONCLUSION Favipiravir did not exert any beneficial effect in preventing clinical deterioration from non-hypoxia to hypoxia among COVID-19 patients with co-morbidity. There was also no effect in reducing incidences of mechanical ventilation, ICU admission, and mortality during hospitalization. ACKNOWLEDGEMENT The authors would like to thank researchers from all 14 designated COVID-19 public hospitals and Institute for Clinical Research for the contribution in this study. We are grateful of participation from all our patients. We also thank the Director-General of Health Malaysia for his permission to publish this study. Members of the Malaysian Favipiravir Study
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Late treatment
is less effective
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