The West Africa Lassa fever Consortium pre-positioned protocol for a Phase II/III adaptive, randomised, controlled, platform trial to evaluate multiple Lassa fever therapeutics

Josephine Bourner*, Alex Paddy Salam, Marie Jaspard, Adebola Olayinka, Camille Fritzell, Bronner Goncalves, Michel Vaillant, Tansy Edwards, Cyril Erameh, Nnennaya Ajayi, Michael Ramharter, Piero Olliaro

*Corresponding author for this work

    Research output: Contribution to journalArticleResearchpeer-review

    1 Citation (Scopus)

    Abstract

    Background: This is a standardized, pre-positioned protocol for the coordinated evaluation of Lassa fever therapeutics. The protocol is the product of discussions that took place in 2021 and 2022 among international investigators from a wide range of scientific and medical disciplines working together within the West Africa Lassa fever Consortium (WALC). Methods: This is a clinical Phase II/III multicentre randomised controlled platform trial using a superiority framework with an equal allocation ratio and a composite primary endpoint of all-cause mortality OR new onset of i) acute kidney failure (AKF), OR ii) acute respiratory failure (ARF), OR iii) shock assessed from enrolment (D0) to D28. Discussion: This pre-positioned protocol was developed by the WALC and made available for adaptation and implementation by the wider Lassa fever research community in order to generate efficient, reliable, and comparable evidence for Lassa fever therapeutics.

    Original languageEnglish
    Article number122
    JournalWellcome Open Research
    Volume8
    Issue number122
    DOIs
    Publication statusPublished - 16 Mar 2023

    Keywords

    • Lassa fever; pre-positioned protocol; Phase II/III; clinical trial

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