Optimal Dose and #Safety of Intravenous #Favipiravir in Hospitalized Patients With #COVID19: A Dose-Escalating, Randomized Controlled Phase Ib Study
Abstract AGILE (NCT04746183) is a Phase Ib/IIa platform, evaluating candidates to treat COVID-19 . Candidate Specific Trial 6 evaluated the safety and optimal dose of a novel intravenous formulation of favipiravir in a dose-escalating, open-label, randomized, controlled, Bayesian adaptive Phase Ib trial . Hospitalized adults with PCR-confirmed SARS-CoV-2 infection , within 14 days of symptomatic COVID-19 were randomized 2:1 in groups of 6 (n = 4 favipiravir, n = 2 standard of care) to ascending doses of intravenous favipiravir twice daily (b.i.d.) for 7 days or standard of care. Clinical data, safety evaluations, virology and pharmacokinetic samples were collected. The primary outcome was safety . Secondary outcomes included clinical, pharmacokinetic and virological endpoints . Twenty-four participants enrolled between September 10, 2022 and November 1, 2023 [10/24 female; median age 74 years (range 52–93)]. Favipiravir was well tolerated despite a high background rate of unrelat...