{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T11:59:21Z","timestamp":1773230361963,"version":"3.50.1"},"update-to":[{"DOI":"10.12688\/wellcomeopenres.19041.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2023,6,2]],"date-time":"2023-06-02T00:00:00Z","timestamp":1685664000000}}],"reference-count":46,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2023,6,2]],"date-time":"2023-06-02T00:00:00Z","timestamp":1685664000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004440","name":"Wellcome","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004440","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns4:p>\n                    <ns4:bold>Background<\/ns4:bold>\n                    : 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).\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Methods<\/ns4:bold>\n                    : 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.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Discussion<\/ns4:bold>\n                    : 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.\n                  <\/ns4:p>","DOI":"10.12688\/wellcomeopenres.19041.2","type":"journal-article","created":{"date-parts":[[2023,6,2]],"date-time":"2023-06-02T07:45:07Z","timestamp":1685691907000},"page":"122","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":4,"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"],"prefix":"10.12688","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4687-8380","authenticated-orcid":false,"given":"Josephine","family":"Bourner","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alex 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status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/wellcomeopenres.21622.r59181, Emmanuel Bottieau, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, 21 Jun 2023, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/8-122\/v2#referee-response-59181","order":0,"name":"referee-response-59181","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.21110.r55702, George O. Akpede, Irrua Specialist Teaching Hospital, Irrua, 04 May 2023, version 1, 2 approved with reservations","URL":"https:\/\/wellcomeopenresearch.org\/articles\/8-122\/v1#referee-response-55702","order":1,"name":"referee-response-55702","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Josephine Bourner<\/b>; \n<i>Posted: 25 May 2023<\/i>; Dear Dr Akpede,  We would like to thank you for the generous feedback you\u2019ve provided on the protocol. Based on your feedback we have made a number of clarifications and additions to the manuscript, and provided a point-by-point summary of our response in the PDF file linked here.  We hope that our responses provide sufficient detail for your approval.  Sincerely, Josephine Bourner  On behalf of the West Africa Lassa fever Consortium (WALC): Work Package 2 working group","URL":"https:\/\/wellcomeopenresearch.org\/articles\/8-122\/v2#referee-comment-5331","order":2,"name":"referee-comment-5331","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.21622.r77058, David Simons, Department of Anthropology, The Pennsylvania State University, State College, PA, 28 Aug 2024, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/8-122\/v2#referee-response-77058","order":3,"name":"referee-response-77058","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"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.","order":4,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}