{"id":8713,"date":"2020-08-04T11:02:43","date_gmt":"2020-08-04T18:02:43","guid":{"rendered":"https:\/\/depts.washington.edu\/pandemicalliance\/?p=8713"},"modified":"2021-04-06T11:04:20","modified_gmt":"2021-04-06T18:04:20","slug":"interim-results-of-a-phase-ii-iii-multicenter-randomized-clinical-trial-of-avifavir-in-hospitalized-patients-with-covid-19","status":"publish","type":"post","link":"https:\/\/depts.washington.edu\/pandemicalliance\/2020\/08\/04\/interim-results-of-a-phase-ii-iii-multicenter-randomized-clinical-trial-of-avifavir-in-hospitalized-patients-with-covid-19\/","title":{"rendered":"Interim Results of a Phase II\/III Multicenter Randomized Clinical Trial of AVIFAVIR in Hospitalized Patients with COVID-19"},"content":{"rendered":"<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"43\" data-aria-posinset=\"1\" data-aria-level=\"1\"><i><span data-contrast=\"none\">[pre<\/span><\/i><i><span data-contrast=\"none\">&#8211;<\/span><\/i><i><span data-contrast=\"none\">print, not peer-reviewed]<\/span><\/i><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">Ivashchenko<\/span><span data-contrast=\"auto\">\u00a0et al. report on a ph<\/span><span data-contrast=\"auto\">a<\/span><span data-contrast=\"auto\">se II\/III randomized clinical trial of\u00a0<\/span><span data-contrast=\"auto\">the antiviral agent\u00a0<\/span><span data-contrast=\"auto\">favipiravir<\/span><span data-contrast=\"auto\">. H<\/span><span data-contrast=\"auto\">ospitalized\u00a0<\/span><span data-contrast=\"auto\">patients with pneumonia and confirmed SARS-CoV-2\u00a0<\/span><span data-contrast=\"auto\">infection\u00a0<\/span><span data-contrast=\"auto\">(n=60)\u00a0<\/span><span data-contrast=\"auto\">were randomized\u00a0<\/span><span data-contrast=\"auto\">in<\/span><span data-contrast=\"auto\">\u00a0a 1:1:1 ratio to receive\u00a0<\/span><span data-contrast=\"auto\">low-dose\u00a0<\/span><span data-contrast=\"auto\">favipiravir<\/span><span data-contrast=\"auto\">,\u00a0<\/span><span data-contrast=\"auto\">high-dose\u00a0<\/span><span data-contrast=\"auto\">favipiravir<\/span><span data-contrast=\"auto\">, or standard of care<\/span><span data-contrast=\"auto\">\u00a0(SOC)<\/span><span data-contrast=\"auto\">.\u00a0<\/span><span data-contrast=\"auto\">Patients receiving\u00a0<\/span><span data-contrast=\"auto\">favipiravir<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">(both arms combined)\u00a0<\/span><span data-contrast=\"auto\">were more likely\u00a0<\/span><span data-contrast=\"auto\">than patients in SOC arm<\/span><span data-contrast=\"auto\">\u00a0to have<\/span><span data-contrast=\"auto\">\u00a0viral clearance\u00a0<\/span><span data-contrast=\"auto\">by day 5\u00a0<\/span><span data-contrast=\"auto\">(6<\/span><span data-contrast=\"auto\">3<\/span><span data-contrast=\"auto\">% vs 30<\/span><span data-contrast=\"auto\">%<\/span><span data-contrast=\"auto\">)\u00a0<\/span><span data-contrast=\"auto\">and have\u00a0<\/span><span data-contrast=\"auto\">lower\u00a0<\/span><span data-contrast=\"auto\">median\u00a0<\/span><span data-contrast=\"auto\">time to fever resolution (2 v<\/span><span data-contrast=\"auto\">s<\/span><span data-contrast=\"auto\">\u00a04 days)<\/span><span data-contrast=\"auto\">.<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">Improvements in chest CT scans by day 15 was similar (83%\u00a0<\/span><span data-contrast=\"auto\">favipiravir<\/span><span data-contrast=\"auto\">\u00a0arms vs 75% SOC).\u00a0<\/span><span data-contrast=\"auto\">However,\u00a0<\/span><span data-contrast=\"auto\">at the time of the interim analysis, more patients in the SOC arm<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">(90%) versus the\u00a0<\/span><span data-contrast=\"auto\">favipiravir<\/span><span data-contrast=\"auto\">\u00a0arm (80%)\u00a0<\/span><span data-contrast=\"auto\">had been discharged<\/span><span data-contrast=\"auto\">.<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">Mild to moderate adverse\u00a0<\/span><span data-contrast=\"auto\">drug reactions were reported in 1<\/span><span data-contrast=\"auto\">8<\/span><span data-contrast=\"auto\">% of patients<\/span><span data-contrast=\"auto\">, resulting in\u00a0<\/span><span data-contrast=\"auto\">5%\u00a0<\/span><span data-contrast=\"auto\">early discontinuation<\/span><span data-contrast=\"auto\">.<\/span><span data-contrast=\"auto\">\u00a0<\/span><span data-contrast=\"auto\">Efficacy and safety results were similar for both (high- and low-dose)\u00a0<\/span><span data-contrast=\"auto\">favipiravir<\/span><span data-contrast=\"auto\">\u00a0arms.\u00a0<\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><i><span data-contrast=\"none\">Ivashchenko<\/span><\/i><i><span data-contrast=\"none\">\u00a0et al. (August 4, 2020). Interim Results of a Phase II\/III Multicenter Randomized Clinical Trial of AVIFAVIR in Hospitalized Patients with COVID-19. Pre-print downloaded on August 4 from\u00a0<\/span><\/i><a href=\"https:\/\/doi.org\/10.1101\/2020.07.26.20154724\"><span data-contrast=\"none\">https:\/\/doi.org\/10.1101\/2020.07.26.20154724<\/span><\/a><i><span data-contrast=\"none\">\u00a0<\/span><\/i><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>[pre&#8211;print, not peer-reviewed]\u00a0Ivashchenko\u00a0et al. report on a phase II\/III randomized clinical trial of\u00a0the antiviral agent\u00a0favipiravir. Hospitalized\u00a0patients with pneumonia and confirmed SARS-CoV-2\u00a0infection\u00a0(n=60)\u00a0were randomized\u00a0in\u00a0a 1:1:1 ratio to receive\u00a0low-dose\u00a0favipiravir,\u00a0high-dose\u00a0favipiravir, or standard of care\u00a0(SOC).\u00a0Patients receiving\u00a0favipiravir\u00a0(both arms combined)\u00a0were more likely\u00a0than patients in SOC arm\u00a0to have\u00a0viral clearance\u00a0by day 5\u00a0(63% vs 30%)\u00a0and have\u00a0lower\u00a0median\u00a0time to fever resolution (2 vs\u00a04 days).\u00a0Improvements in chest CT&#8230;<\/p>\n<div><a class=\"more\" href=\"https:\/\/depts.washington.edu\/pandemicalliance\/2020\/08\/04\/interim-results-of-a-phase-ii-iii-multicenter-randomized-clinical-trial-of-avifavir-in-hospitalized-patients-with-covid-19\/\">Read more<\/a><\/div>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[6],"tags":[],"topic":[19],"class_list":["post-8713","post","type-post","status-publish","format-standard","hentry","category-article-summary","topic-testing-and-treatment"],"_links":{"self":[{"href":"https:\/\/depts.washington.edu\/pandemicalliance\/wp-json\/wp\/v2\/posts\/8713","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/depts.washington.edu\/pandemicalliance\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/depts.washington.edu\/pandemicalliance\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/depts.washington.edu\/pandemicalliance\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/depts.washington.edu\/pandemicalliance\/wp-json\/wp\/v2\/comments?post=8713"}],"version-history":[{"count":1,"href":"https:\/\/depts.washington.edu\/pandemicalliance\/wp-json\/wp\/v2\/posts\/8713\/revisions"}],"predecessor-version":[{"id":8714,"href":"https:\/\/depts.washington.edu\/pandemicalliance\/wp-json\/wp\/v2\/posts\/8713\/revisions\/8714"}],"wp:attachment":[{"href":"https:\/\/depts.washington.edu\/pandemicalliance\/wp-json\/wp\/v2\/media?parent=8713"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/depts.washington.edu\/pandemicalliance\/wp-json\/wp\/v2\/categories?post=8713"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/depts.washington.edu\/pandemicalliance\/wp-json\/wp\/v2\/tags?post=8713"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/depts.washington.edu\/pandemicalliance\/wp-json\/wp\/v2\/topic?post=8713"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}