Safety and Efficacy of Favipiravir in COVID-19 Patients with Pneumonia. A randomized, double-blind, placebo-controlled study (FAVID)

Horcajada et al., Research Square, doi:10.21203/rs.3.rs-3279701/v1, FAVID, EudraCT2020-002753-22

Aug 2023

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Underpowered RCT with 44 hospitalized patients in Spain, showing no significant difference with favipiravir treatment in the primary outcome of time to clinical improvement, or in the secondary efficacy outcomes. Adverse events were more frequent in the favipiravir group (68%) compared to placebo (32%), but most were mild.

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risk of death, 382.6% higher, RR 4.83, p = 0.49, treatment 2 of 23 (8.7%), control 0 of 21 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 28.

risk of mechanical ventilation, 37.0% higher, RR 1.37, p = 1.00, treatment 3 of 23 (13.0%), control 2 of 21 (9.5%), day 28.

time to improvement, no change, relative time 1.00, p = 0.45, treatment 23, control 21.

dischage or NEWS <3, 16.7% lower, relative time 0.83, p = 0.64, treatment 23, control 21.

time to viral-, 125.0% higher, relative time 2.25, p = 0.51, treatment 23, control 21.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Horcajada et al., 24 Aug 2023, Double Blind Randomized Controlled Trial, placebo-controlled, Spain, preprint, 14 authors, study period November 2020 - October 2021, trial EudraCT2020-002753-22 (FAVID).

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Safety and Efficacy of Favipiravir in COVID-19 Patients with Pneumonia. A randomized, double-blind, placebo-controlled study (FAVID)

Juan P Horcajada, Rebeca Aldonza, Mónica Real, Silvia Castañeda Espinosa, Elena Sendra, Joan Gomez-Junyent, Inmaculada López-Montesinos, Silvia Gómez-Zorrilla, Silvia Briansó, Montserrat Duran Taberna, Andrés Fernández, Cristina Tarragó, Teresa Auguet Quintillá

doi:10.21203/rs.3.rs-3279701/v1

Purpose: To design a randomized clinical trial to assess the e cacy and safety of favipiravir in patients with COVID-19 disease with pneumonia. Methods: A randomized, double blind, placebo-controlled clinical trial of favipiravir in patients with COVID-19 pneumonia was conducted in 3 Spanish sites. Randomization 1:1 to favipiravir or placebo (in both groups added to the Standard of Care) was performed to treat the patients with COVID-19 pneumonia. The primary endpoint was "time to clinical improvement," measured as an improvement for ≥ two categories on a 7-point WHO ordinal scale in an up to 28 days' time frame. Results: 44 patients were randomized (23 in the favipiravir group and 21 in the placebo group). The median time to clinical improvement was not different between the favipiravir and the placebo arms (10 days for both groups) and none of the secondary endpoints showed signi cant differences between arms. The proportion of adverse events (both serious and non-serious) was statistically different between the favipiravir group (68.29%) and the placebo group (31.7%) (p = 0.019), but there was insu cient statistical evidence to correlate the degree of severity of the events with the treatment groups. Conclusions: Favipiravir administered for ten days to patients with COVID-19 and pneumonia did not improve outcomes compared with placebo. Although this is an underpowered negative study, e cacy results align with other randomized trials. However, in the present study, the non-serious adverse events were more frequent in the favipiravir group.

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