TY - JOUR
T1 - Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics
AU - Bourner, Josephine
AU - Vaillant, Michel
AU - Abdel Salam, Alex Paddy
AU - Jaspard, Marie
AU - Fritzell, Camille
AU - Jacob, Shevin T
AU - Fletcher, Tom E
AU - Ramharter, Michael
AU - Ajayi, Nnennaya
AU - Okogbenin, Sylvanus
AU - Erameh, Cyril
AU - Grant, Donald
AU - Samuels, Robert
AU - Ayodeji, Oladele Oluwafemi
AU - Sprecher, Armand
AU - Gonçalves, Bronner P
AU - Edwards, Tansy
AU - Olliaro, Piero
AU - WALC Work Package 2 Working Group
N1 - Funding:
The work undertaken within the scope of the WALC was
supported by Wellcome.
PY - 2025/2
Y1 - 2025/2
N2 - 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.
AB - 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.
KW - Lassa Fever/drug therapy
KW - Humans
KW - Antiviral Agents/therapeutic use
KW - Lassa virus
KW - Research Design
KW - Ribavirin/therapeutic use
KW - Clinical Trials, Phase II as Topic
KW - Clinical Trials, Phase III as Topic
UR - https://pubmed.ncbi.nlm.nih.gov/39983682/
U2 - 10.3201/eid3102.240251
DO - 10.3201/eid3102.240251
M3 - Article
C2 - 39983682
SN - 1080-6040
VL - 31
SP - 9
EP - 16
JO - Emerging Infectious Diseases
JF - Emerging Infectious Diseases
IS - 2
ER -