Favipiravir in early symptomatic COVID-19, a randomised placebo-controlled trial
James H Mcmahon, Jillian S Y Lau, Anna Coldham, Janine Roney, Michelle Hagenauer, Sally Price, Mellissa Bryant, Jill Garlick, Anne Paterson, Sue J Lee, Jess O'bryan, Anna Hearps, Gilda Tachedjian, Henry Pinskier, Cameron Phillips, Stuart Garrow, Nathan Pinskier, Robert Melvin, Luke Blakeway, Jessica A Wisniewski, Sally Byers, Gnei Z Badoordeen, Stephanie Pereira, Katherine Pragastis, Jason A Trubiano, Kyra Y L Chua, Marion Kainer, James S Molton, Bradley J Gardiner, Anna B Pierce, Allen Cheng, Benjamin A Rogers, Anton Y Peleg
eClinicalMedicine, doi:10.1016/j.eclinm.2022.101703
Background Well tolerated antivirals administered early in the course of COVID-19 infection when the viremia is highest could prevent progression to severe disease. Favipiravir inhibits SARS-CoV-2 viral replication in vitro with evidence of clinical benefit in open label trials. Placebo controlled studies of people with early symptomatic COVID-19 with regular assessments of SARS-CoV-2 viral load can determine if it has an antiviral effect and improves clinical outcomes. Methods People with PCR-confirmed COVID-19 and 5 days or less of symptoms were randomised 1:1 to favipiravir 1800 mg on day 1, then 800 mg twice daily or matched placebo for 14 days. SARS-CoV-2 viral load was quantitated from second daily self-collected nose-throat swabs while receiving study drug. The primary endpoint was time to virological cure defined as 2 successive swabs negative for SARS-CoV-2 by PCR and secondary outcomes were progression of disease severity, symptom resolution and safety.
Contributors JHM and AYP conceptualized and designed the study. SJL, JHM and AYP analysed and interpreted the data and drafted the figures and tables. JHM JSYL, BR, AC, SJL and AYP drafted the protocol. JHM acquired the funding. AC, JR, MB, SP, JG, MH, JO'B, AP collected and entered the data and administered the project. AH and GT designed and performed the virological analyses. LB, JAW, SB, GZB, SP ad KP collected and processed all study specimens. HP, SG, NP, CP, RM, BR, JT, KC, MK, JM, AP, BG and JSYL identified study participants for enrolment. JHM and JSYL consented participants, performed study procedures and assessments of adverse effects. JHM wrote the first draft of the manuscript. All authors contributed, reviewed and edited the manuscript.
Data sharing statement Anonymized raw data will be available upon a written request to the corresponding author. The data will be shared with requesters after approval and a signed datasharing agreement between the requester and the sponsor Alfred Health.
Declaration of interests All authors declare no competing interests.
Supplementary materials Supplementary material associated with this article can be found in the online version at doi:10.1016/j. eclinm.2022.101703.
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