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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality -200% Improvement Relative Risk Ventilation -200% Hospitalization time -20% no CI Recovery 58% Recovery (b) -46% Recovery time 43% no CI Recovery time (b) -15% no CI Time to viral- 47% primary Favipiravir  Finberg et al.  LATE TREATMENT  RCT Is late treatment with favipiravir beneficial for COVID-19? RCT 50 patients in the USA (April - October 2020) Faster viral clearance with favipiravir (p=0.042) Finberg et al., Open Forum Infectious .., Dec 2021 Favors favipiravir Favors control

US201 Study: A Phase 2, Randomized Proof-of-Concept Trial of Favipiravir for the Treatment of COVID-19

Finberg et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab56310, NCT04358549
Dec 2021  
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Small very late treatment RCT in the USA, with 25 favipiravir and 25 control patients, showing faster viral clearance with treatment. The benefit was only seen in patients <8 days from symptom onset. There were no significant differences in clinical outcomes. The death in the favipiravir group occurred after discharge and was believed to be unrelated to COVID-19 or favipiravir.
risk of death, 200.0% higher, RR 3.00, p = 1.00, treatment 1 of 25 (4.0%), control 0 of 25 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 60.
risk of mechanical ventilation, 200.0% higher, RR 3.00, p = 1.00, treatment 1 of 25 (4.0%), control 0 of 25 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
hospitalization time, 19.8% higher, relative time 1.20, treatment 25, control 25.
risk of no recovery, 58.1% lower, OR 0.42, p = 0.08, treatment 25, control 25, inverted to make OR<1 favor treatment, day 8 mid-recovery, 6-point ordinal scale, RR approximated with OR.
risk of no recovery, 46.2% higher, OR 1.46, p = 0.54, treatment 25, control 25, inverted to make OR<1 favor treatment, day 15, 6-point ordinal scale, RR approximated with OR.
recovery time, 42.9% lower, relative time 0.57, treatment 25, control 25, median time to aggregate NEWS2 score ≤2 or discharge.
recovery time, 15.4% higher, relative time 1.15, treatment 25, control 25.
time to viral-, 46.7% lower, relative time 0.53, p = 0.04, treatment 25, control 25, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Finberg et al., 7 Dec 2021, Randomized Controlled Trial, USA, peer-reviewed, 10 authors, study period 17 April, 2020 - 30 October, 2020, average treatment delay 8.4 days, trial NCT04358549 (history).
This PaperFavipiravirAll
US201 Study: A Phase 2, Randomized Proof-of-Concept Trial of Favipiravir for the Treatment of COVID-19
Robert W Finberg, Madiha Ashraf, Boris Julg, Folusakin Ayoade, Jai G Marathe, Nicolas C Issa, MD Jennifer P Wang, Siraya Jaijakul, Lindsey R Baden, Carol Epstein
Open Forum Infectious Diseases, doi:10.1093/ofid/ofab563
Background. Favipiravir is used to treat influenza, and studies demonstrate that it has antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods. We performed a randomized, open-label, multicenter, phase 2 proof-of-concept trial of favipiravir in hospitalized adult patients with polymerase chain reaction (PCR)-positive coronavirus disease 2019 . Patients were randomized to standard of care (SOC) or favipiravir treatment (1800 mg per os twice a day [b.i.d.] on day 1, followed by 1000 mg b.i.d. for 13 days). The primary end point was time to viral clearance on day 29. Results. Fifty patients were enrolled and stratified by disease severity (critical disease, severe disease, or mild to moderate disease). Nineteen patients were censored from the event of viral clearance based on being SARS-CoV-2 PCR-negative at the study outset, being PCR-positive at day 29, or because of loss to follow-up. Data from the 31 remaining patients who achieved viral clearance show enhanced viral clearance in the favipiravir group compared with the SOC group by day 29, with 72% of the favipiravir group and 52% of the SOC group being evaluable for viral clearance through day 29. The median time to viral clearance was 16.0 days (90% CI, 12.0 to 29.0) in the favipiravir group and 30.0 days (90% CI, 12.0 to 31.0) in the SOC group. A post hoc analysis revealed an effect in the subgroup of patients who were neutralizing antibody-negative at randomization. Treatment-emergent adverse events were equally distributed between the groups. Conclusions. We demonstrate that favipiravir can be safely administered to hospitalized adults with COVID-19 and believe that further studies are warranted. registration. NCT04358549.
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Late treatment
is less effective
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