Journal Article

Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics

Okogbenin, Sylvanus, Samuels, Robert, Vaillant, Michel, Ajayi, Nnennaya, Erameh, Cyril, Bourner, Josephine, Jacob, Shevin T., Fritzell, Camille, Fletcher, Tom E., Ramharter, Michael, Ayodeji, Oladele Oluwafemi, Edwards, Tansy, Grant, Donald, Gonçalves, Bronner P., Abdel Salam, Alex Paddy, Sprecher, Armand, Olliaro, Piero, Jaspard, Marie

2025

Overview

The current recommendation for treating Lassa fever with ribavirin is supported only by weak evidence. Given the persistent effects in areas with endemic transmission and epidemic potential, there is an urgent need to reassess ribavirin and investigate other potential therapeutic candidates; however, a robust clinical trial method adapted to Lassa fever epidemiology has not yet been established. We propose an adaptive phase II/III multicenter randomized controlled platform trial that uses a superiority framework with an equal allocation ratio and accounts for challenges selecting the primary end point and estimating the target sample size by using an interim analysis.

• Publisher: Centers for Disease Control and Prevention
• Subject: Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics / Antiviral Agents - therapeutic use / Clinical trials / Clinical Trials, Phase II as Topic / Clinical Trials, Phase III as Topic / Data collection / Design / Epidemiology / Fatalities / Fever / Humans / Illnesses / Infectious diseases / International organizations / Lassa fever / Lassa Fever - drug therapy / Lassa Fever - epidemiology / Lassa Fever - virology / Lassa virus - drug effects / Life Sciences / Multicenter Studies as Topic / Online Report / Patients / phase II/III multicenter randomized controlled platform trial / Public health / Randomized Controlled Trials as Topic / Research Design / Ribavirin - therapeutic use / Santé publique et épidémiologie / viruses / Womens health / Working groups