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

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

doi:10.3201/eid3102.240251

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

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

Clinical Sciences

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English
Pages (from-to)	e9-e16
Journal	Emerging Infectious Diseases
Volume	31
Issue number	2
DOIs	https://doi.org/10.3201/eid3102.240251
Publication status	Published - 21 Jan 2025

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10.3201/eid3102.240251

24-0251Final published version, 610 KBLicence: Unspecified

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Bourner, J., Vaillant, M., Salam, A. P. A., Jaspard, M., Fritzell, C., Jacob, S., Fletcher, T., Ramharter, M., Ajayi, N., Okogbenin, S., Erameh, C., Grant, D., Samuels, R., Ayodeji, O. O., Sprecher, A., Gonçalves, B. P., Edwards, T., & Olliaro, P. (2025). Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics. Emerging Infectious Diseases, 31(2), e9-e16. https://doi.org/10.3201/eid3102.240251

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title = "Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics",

abstract = "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.",

author = "Josephine Bourner and Michel Vaillant and Salam, \{Alex Paddy Abdel\} and Marie Jaspard and Camille Fritzell and Shevin Jacob and Tom Fletcher and Michael Ramharter and Nnennaya Ajayi and Sylvanus Okogbenin and Cyril Erameh and Donald Grant and Robert Samuels and Ayodeji, \{Oladele Oluwafemi\} and Armand Sprecher and Gon{\c c}alves, \{Bronner P.\} and Tansy Edwards and Piero Olliaro",

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doi = "10.3201/eid3102.240251",

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Bourner, J, Vaillant, M, Salam, APA, Jaspard, M, Fritzell, C, Jacob, S , Fletcher, T, Ramharter, M, Ajayi, N, Okogbenin, S, Erameh, C, Grant, D, Samuels, R, Ayodeji, OO, Sprecher, A, Gonçalves, BP, Edwards, T & Olliaro, P 2025, 'Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics', Emerging Infectious Diseases, vol. 31, no. 2, pp. e9-e16. https://doi.org/10.3201/eid3102.240251

TY - JOUR

T1 - Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics

AU - Bourner, Josephine

AU - Vaillant, Michel

AU - Salam, Alex Paddy Abdel

AU - Jaspard, Marie

AU - Fritzell, Camille

AU - Jacob, Shevin

AU - Fletcher, Tom

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

PY - 2025/1/21

Y1 - 2025/1/21

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.

U2 - 10.3201/eid3102.240251

DO - 10.3201/eid3102.240251

M3 - Article

SN - 1080-6040

VL - 31

SP - e9-e16

JO - Emerging Infectious Diseases

JF - Emerging Infectious Diseases

IS - 2

ER -

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

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