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

doi:10.12688/wellcomeopenres.19041.1

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

^*Corresponding author for this work

Competence Center for Methodology and Statistics

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

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 language	English
Journal	Wellcome Open Research
Volume	8
Issue number	122
DOIs	https://doi.org/10.12688/wellcomeopenres.19041.1
Publication status	Published - 16 Mar 2023

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10.12688/wellcomeopenres.19041.1Licence: CC BY

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Bourner, J., Salam, A. P., Jaspard, M., Olayinka, A., Fritzell, C., Goncalves, B., Vaillant, M., Edwards, T., Erameh, C., & Ajayi, N. (2023). 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. Wellcome Open Research, 8(122). https://doi.org/10.12688/wellcomeopenres.19041.1

@article{05225bba58254f469c2e3d743bd91d94,

title = "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",

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.",

author = "Josephine Bourner and Salam, {Alex Paddy} and Marie Jaspard and Adebola Olayinka and Camille Fritzell and Bronner Goncalves and Michel Vaillant and Tansy Edwards and Cyril Erameh and Nnennaya Ajayi",

note = "Grant information: This pre-positioned protocol was developed within the scope of the West Africa Lassa fever Consortium, funded by Wellcome. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript ",

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doi = "10.12688/wellcomeopenres.19041.1",

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Bourner, J, Salam, AP, Jaspard, M, Olayinka, A, Fritzell, C, Goncalves, B, Vaillant, M, Edwards, T, Erameh, C & Ajayi, N 2023, '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', Wellcome Open Research, vol. 8, no. 122. https://doi.org/10.12688/wellcomeopenres.19041.1

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. / Bourner, Josephine; Salam, Alex Paddy; Jaspard, Marie et al.
In: Wellcome Open Research, Vol. 8, No. 122, 16.03.2023.

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

TY - JOUR

T1 - 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

AU - Bourner, Josephine

AU - Salam, Alex Paddy

AU - Jaspard, Marie

AU - Olayinka, Adebola

AU - Fritzell, Camille

AU - Goncalves, Bronner

AU - Vaillant, Michel

AU - Edwards, Tansy

AU - Erameh, Cyril

AU - Ajayi, Nnennaya

N1 - Grant information: This pre-positioned protocol was developed within the scope of the West Africa Lassa fever Consortium, funded by Wellcome. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript

PY - 2023/3/16

Y1 - 2023/3/16

N2 - 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.

AB - 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.

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VL - 8

JO - Wellcome Open Research

JF - Wellcome Open Research

IS - 122

ER -

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

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