Clinical effectiveness, safety, and viral mutagenicity of oral favipiravir for COVID-19: results from a community-based, open-label, randomized Phase III trial
Matthew Tate, Christopher J R Illingworth, Gordon Macgregor, Laura Cunningham, Laura Divers, Elaine Mccartney, Lucy Paterson, Caroline Kelly, Ann Shaw, Jonathan S Perkins, Vanessa Silva, Poppy Holland, Carol Dalton, Samantha Carmichael, Elizabeth Douglas, Pamela Surtees, Janet T Scott, Colin Berry, Sreenu Vattipally, Ana Da Silva Filipe, Lily Tong, Rory Gunson, Iain B Mcinnes, Robert Jones, Emma Thomson, Kevin G Blyth, Claire Rooney, Erin Mcgarry, Rosemary Meharry, Lauren Devers, Lisa Akyol, Jennifer Pearson, Sarah Nichol, Helen Casey, Michael Mcgettrick, James Brock, Nathan Smith, Rebecca Mccall
Antimicrobial Agents and Chemotherapy, doi:10.1128/aac.00054-25
Early community treatment of severe acute respiratory syndrome coro navirus-2 (SARS-CoV-2) infection may reduce severe coronavirus disease (COVID-19) incidence. We evaluated clinical effectiveness, safety, and SARS-CoV-2 mutagenicity of favipiravir, an oral viral RNA polymerase inhibitor. We performed an open-label, community-based, randomized Phase III trial, recruiting non-hospitalized adults with mild COVID-19 (WHO ordinal severity score [OSS] ≤ 3). Positive cases were invited to web-based self-screening within 24 h using public health data. Exclusion criteria included symptoms for >7 days, pregnancy/breastfeeding, severe renal/liver disease, gout, and licensed antiviral eligibility. Participants were randomized 1:1 to 10 days favipiravir (Day 1: 3,600 mg; days 2-10: 1,600 mg) or no additional treatment. The primary endpoint was worst recorded OSS up to and including Day 15 (intention-totreat). The target recruitment was 302. Secondary endpoints included adverse event (AE) rate to Day 60, time-to-viral clearance (TTVC), time-to-symptom resolution (TTSR), and SARS-CoV-2 sequencing variant rate (≥5% frequency) at Day 15 (registration ISRCTN: 31062548; EudraCT: 2020-001904-41). A total of 68,788 adults were invited, and 302 (0.4%) were subsequently randomized between December 2020 and July 2022 (favipiravir [n = 152]: standard care [n = 150]). Mean (SD) age was 47.2 (13.2), and 230/302 (76%) were vaccinated. Severe outcomes were infrequent, with no intensive care unit admissions/deaths. There was no difference in the primary endpoint: odds ratio 1.18 (95% confidence interval [CI] 0.63-2.20), TTSR (HR 1.03 [95% CI 0.81-1.31]), or TTVC (HR 1.13 [95% CI 0.65-1.97]). Favipiravir was well tolerated with few AEs but was associated with increased variant frequency, including C-to-U mutations. Community administration of favipiravir for mild COVID-19 was not associated with clinical benefits or safety concerns but was associated with SARS-CoV-2 mutagenicity. CLINICAL TRIALS This study is registered with ISRCTN as 31062548 and with EU-CTR as 2020-001904-41. KEYWORDS COVID-19, antiviral agents, randomized controlled trial S evere acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection remains as a significant public health concern (1). Widespread vaccination has reduced the incidence of severe coronavirus disease (COVID-19) (2), but infection continues to cause substantial morbidity, particularly in patients with impaired immunity and in communities with poor vaccine uptake (3). This places a premium on the develop ment of additional strategies to minimize the impact of future infection waves (4).
AUTHOR AFFILIATIONS
ETHICS APPROVAL The trial protocol was approved by the West of Scotland Research Ethics Com mittee (20/WS/0073) and UK Medicines & Healthcare Products Regulatory Agency (CTA24712/0052/001-0001). NHSGGC and the University of Glasgow co-sponsored the trial. The NHSGGC Caldicott Guardian approved sharing of test data by PHS. Recruitment, primary endpoint, and safety data were reviewed by an Independent Data Monitoring & Safety Committee chaired by C.B.
ADDITIONAL FILES The following material is available online.
Supplemental Material Supplementary material (AAC00054-25-S0001.docx). Fig. S1 to S4; Tables S1 to S5 .
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"abstract": "<jats:title>ABSTRACT</jats:title>\n <jats:sec>\n <jats:title/>\n <jats:p>\n Early community treatment of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection may reduce severe coronavirus disease (COVID-19) incidence. We evaluated clinical effectiveness, safety, and SARS-CoV-2 mutagenicity of favipiravir, an oral viral RNA polymerase inhibitor. We performed an open-label, community-based, randomized Phase III trial, recruiting non-hospitalized adults with mild COVID-19 (WHO ordinal severity score [OSS] ≤ 3). Positive cases were invited to web-based self-screening within 24 h using public health data. Exclusion criteria included symptoms for >7 days, pregnancy/breastfeeding, severe renal/liver disease, gout, and licensed antiviral eligibility. Participants were randomized 1:1 to 10 days favipiravir (Day 1: 3,600 mg; days 2-10: 1,600 mg) or no additional treatment. The primary endpoint was worst recorded OSS up to and including Day 15 (intention-to-treat). The target recruitment was 302. Secondary endpoints included adverse event (AE) rate to Day 60, time-to-viral clearance (TTVC), time-to-symptom resolution (TTSR), and SARS-CoV-2 sequencing variant rate (≥5% frequency) at Day 15 (registration ISRCTN: 31062548; EudraCT: 2020-001904-41). A total of 68,788 adults were invited, and 302 (0.4%) were subsequently randomized between December 2020 and July 2022 (favipiravir [\n <jats:italic toggle=\"yes\">n</jats:italic>\n = 152]: standard care [\n <jats:italic toggle=\"yes\">n</jats:italic>\n = 150]). Mean (SD) age was 47.2 (13.2), and 230/302 (76%) were vaccinated. Severe outcomes were infrequent, with no intensive care unit admissions/deaths. There was no difference in the primary endpoint: odds ratio 1.18 (95% confidence interval [CI] 0.63–2.20), TTSR (HR 1.03 [95% CI 0.81–1.31]), or TTVC (HR 1.13 [95% CI 0.65–1.97]). Favipiravir was well tolerated with few AEs but was associated with increased variant frequency, including C-to-U mutations. Community administration of favipiravir for mild COVID-19 was not associated with clinical benefits or safety concerns but was associated with SARS-CoV-2 mutagenicity.\n </jats:p>\n <jats:sec>\n <jats:title>CLINICAL TRIALS</jats:title>\n <jats:p>\n This study is registered with ISRCTN as\n <jats:related-object xmlns:xlink=\"http://www.w3.org/1999/xlink\" document-id=\"31062548\" document-id-type=\"clinical-trial-number\" id=\"RO1\" source-id=\"ISRCTN\" source-id-type=\"registry-name\" source-type=\"clinical-trials-registry\" xlink:href=\"https://www.isrctn.com/ISRCTN31062548?q=31062548&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10\">31062548</jats:related-object>\n and with EU-CTR as\n <jats:related-object xmlns:xlink=\"http://www.w3.org/1999/xlink\" document-id=\"2020-001904-41\" document-id-type=\"clinical-trial-number\" id=\"RO2\" source-id=\"EU-CTR\" source-id-type=\"registry-name\" source-type=\"clinical-trials-registry\" xlink:href=\"https://www.clinicaltrialsregister.eu/ctr-search/search?query=2020-001904-41\">2020-001904-41</jats:related-object>\n .\n </jats:p>\n </jats:sec>\n </jats:sec>",
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