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All Studies   Meta Analysis    Recent:   

Favipiravir in patients with early mild-to-moderate COVID-19: a randomized controlled trial

Golan et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac712, PRESECO, NCT04600895
Sep 2022  
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Mortality 67% Improvement Relative Risk Progression 2% Progression (b) 7% Recovery 4% Time to viral- 14% Favipiravir  PRESECO  EARLY TREATMENT  DB RCT Is early treatment with favipiravir beneficial for COVID-19? Double-blind RCT 1,187 patients in the USA (November 2020 - October 2021) Faster viral clearance with favipiravir (p<0.000001) c19early.org Golan et al., Clinical Infectious Dise.., Sep 2022 Favorsfavipiravir Favorscontrol 0 0.5 1 1.5 2+
RCT low-risk (1 death in the control arm) patients in the USA, showing no significant differences with favipiravir. A majority of trial outcomes were modified after completion:1. 44% of patients had no detectable viral load at baseline in the viral shedding sub-study. The primary outcome required 4 days of sustained clinical recovery and occurred after a median of 7 days, suggesting there was limited room for improvement in the population studied. The percentages for viral clearance at day 10 do not match any number of the reported group sizes. Authors write "of the six RCTs conducted", however there has been at least 24 other RCTs at the time of publication2. 1800mg bid day 1, 800mg bid days 2-10.
risk of death, 66.9% lower, RR 0.33, p = 0.50, treatment 0 of 599 (0.0%), control 1 of 588 (0.2%), NNT 588, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 28.
risk of progression, 1.8% lower, RR 0.98, p = 1.00, treatment 11 of 599 (1.8%), control 11 of 588 (1.9%), NNT 2911, narrow definition.
risk of progression, 7.1% lower, RR 0.93, p = 0.44, treatment 159 of 599 (26.5%), control 168 of 588 (28.6%), NNT 49, broad definition.
risk of no recovery, 4.5% lower, RR 0.96, p = 0.79, treatment 73 of 599 (12.2%), control 75 of 588 (12.8%), NNT 176.
time to viral-, 14.3% lower, relative time 0.86, p < 0.001, treatment median 6.0 IQR 2.0 n=140, control median 7.0 IQR 2.0 n=132, 50% conversion.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Golan et al., 6 Sep 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, 9 authors, study period November 2020 - October 2021, trial NCT04600895 (history) (PRESECO). Contact: ygolan@appilitherapeutics.com.
This PaperFavipiravirAll
MD, MS Yoav Golan, Jesus Abraham, MD, Kohler Simon Campos, Milstein Research, S A De, MD Rodolfo Hanabergh, MD, Verus Yaneicy Gonzales-Rojas, MD Reynaldo Lopez, M.D. (deceased Robert Finberg, MD Armand Balboni
Background: Despite vaccination, many remain vulnerable to COVID-19 and its complications. Oral antivirals to prevent COVID-19 progression are vital. Based upon perceived potency and clinical efficacy, favipiravir is widely used to treat COVID-19. Evidence from large randomized controlled trials (RCT) is lacking. Methods: In this multicenter double-blinded placebo-controlled RCT, adults with early mild-tomoderate COVID-19 were 1:1 randomized to favipiravir or placebo. The study evaluated time to sustained clinical recovery (TT-SCR), COVID-19 progression, and cessation of viral shedding. Results: Of 1187 analyzed patients across 40 centers, 83.3% were Hispanic, 89.0% unvaccinated, 70.3% SARS-CoV-2 seronegative, and 77.8% had risk factors for COVID-19 progression. The median time from symptom presentation and from positive test to randomization was three and two days, respectively. There was no difference in TT-SCR (median of 7 days for both groups; p=0.80), COVID-19 progression [11 patients each (1.9% vs. 1.8%); p=0.96], time to undetectable virus [median=6 days, 95% CI (6-8) vs. 7 days, 95% CI (6-9)], or in undetectable virus by end of therapy (73.4% vs. 72.3%; p=0.94). Outcomes were consistent across the analyzed sub-groups. Adverse events were observed in 13.8% and 14.8% of favipiravir-treated and placebo-treated subjects, respectively. Uric acid elevation was more frequent among favipiravir-treated subjects (19.9% vs. 2.8%). Conclusions : Favipiravir was well tolerated but lacked efficacy in TT-SCR, progression to severe COVID-19, or cessation of viral shedding and should not be used to treat patients with COVID-19. (Supported by Appili Therapeutics
Jesus Abraham Simon Campos, MD: Advisor and speaker: Pfizer, Astra Zeneca, and Regeneron (paid to author). Served as site PI in this clinical trial and reimbursed for subject enrollment. Consulting fees include ADVISORY BOARD ASTRAZENECA and ADVISORY BOARD PFIZER (paid to author). Rob
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' 'Evidence from large randomized controlled trials (RCT) is lacking.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>In this multicenter double-blinded placebo-controlled RCT, adults ' 'with early mild-to-moderate COVID-19 were 1:1 randomized to favipiravir or placebo. The study ' 'evaluated time to sustained clinical recovery (TT-SCR), COVID-19 progression, and cessation ' 'of viral shedding.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>Of 1187 analyzed patients across 40 centers, 83.3% were Hispanic, ' '89.0% unvaccinated, 70.3% SARS-CoV-2 seronegative, and 77.8% had risk factors for COVID-19 ' 'progression. The median time from symptom presentation and from positive test to ' 'randomization was three and two days, respectively. 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