Horcajada Gallego, Juan PabloAldonza, RebecaReal, MónicaCastañeda, SilviaSendra, ElenaGómez Junyent, JoanLópez Montesinos, InmaculadaGómez-Zorrilla, SilviaBriansó, SilviaDuran Taberna, MontserratFernández, AndrésTarragó, CristinaAuguet-Quintillá, TeresaCOVID-MAR GroupCOVID-HJ23 group2024-11-062024-11-062024Horcajada JP, Aldonza R, Real M, Castañeda-Espinosa S, Sendra E, Gomez-Junyent J, et al. Safety and efficacy of favipiravir in COVID-19 patients with pneumonia. A randomized, double-blind, placebo-controlled study (FAVID). Pneumonia (Nathan). 2024 Feb 25;16(1):3. DOI: 10.1186/s41479-023-00124-62200-6133http://hdl.handle.net/10230/68443Purpose: To design a randomized clinical trial to assess the efficacy 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 three 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: Forty-four 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 significant 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 insufficient statistical evidence to correlate the degree of severity of the events with the treatment group. 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, efficacy results align with other randomized trials. However, in the present study, the non-serious adverse events were more frequent in the favipiravir group.application/pdfeng© The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.info:eu-repo/semantics/articlehttp://dx.doi.org/10.1186/s41479-023-00124-6COVID-19FavipiravirPneumoniaRandomized clinical trialinfo:eu-repo/semantics/openAccess