Safety and efficacy of favipiravir in COVID-19 patients with pneumonia. A randomized, double-blind, placebo-controlled study (FAVID)

{ 'indexed': {'date-parts': [[2024, 2, 25]], 'date-time': '2024-02-25T01:41:18Z', 'timestamp': 1708825278942}, 'reference-count': 33, 'publisher': 'Springer Science and Business Media LLC', 'issue': '1', 'license': [ { 'start': { 'date-parts': [[2024, 2, 25]], 'date-time': '2024-02-25T00:00:00Z', 'timestamp': 1708819200000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}, { 'start': { 'date-parts': [[2024, 2, 25]], 'date-time': '2024-02-25T00:00:00Z', 'timestamp': 1708819200000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0'}], 'funder': [{'name': 'Ferrer Internacional, S.A.'}], 'content-domain': {'domain': ['link.springer.com'], 'crossmark-restriction': False}, 'abstract': '<jats:title>Abstract</jats:title><jats:sec>\n' ' <jats:title>Purpose</jats:title>\n' ' <jats:p>To design a randomized clinical trial to assess the efficacy and ' 'safety of favipiravir in patients with COVID-19 disease with pneumonia.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>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.</jats:p>\n" ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>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.</jats:p>\n' ' <jats:p>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%) ' '(<jats:italic>p</jats:italic> = 0.019), but there was insufficient statistical evidence to ' 'correlate the degree of severity of the events with the treatment group.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>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.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1186/s41479-023-00124-6', 'type': 'journal-article', 'created': {'date-parts': [[2024, 2, 25]], 'date-time': '2024-02-25T01:02:11Z', 'timestamp': 1708822931000}, 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Safety and efficacy of favipiravir in COVID-19 patients with pneumonia. 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