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Immunomodulatory therapy in children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS, MIS-C; RECOVERY): a randomised, controlled, open-label, platform trial

Lookup NU author(s): Professor Marieke Emonts-le ClercqORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Publication metadata

Author(s): RECOVERY Collaborative Group, Faust SN, Staplin N, Whittaker E, Jones CE, Jaki T, Emonts M, et al

Publication type: Article

Publication status: Published

Journal: The Lancet Child & Adolescent Health

Year: 2024

Pages: epub ahead of print

Online publication date: 22/01/2024

Acceptance date: 17/11/2023

Date deposited: 20/11/2023

ISSN (print): 2352-4642

ISSN (electronic): 2352-4650

Publisher: The Lancet Publishing Group

URL: https://doi.org/10.1016/S2352-4642(23)00316-4

DOI: 10.1016/S2352-4642(23)00316-4

Data Access Statement: The protocol, consent form, statistical analysis plan, definition and derivation of clinical characteristics and outcomes, training materials, regulatory documents, and other relevant study materials are available online. As described in the protocol, the trial steering committee will facilitate the use of the study data, and approval will not be unreasonably withheld. De-identified participant data will be made available to bona fide researchers registered with an appropriate institution within 3 months of publication. However, the steering committee will need to be satisfied that any proposed publication is of high quality, honours the commitments made to the study participants in the consent documentation and ethical approvals, and is compliant with relevant legal and regulatory requirements (eg, relating to data protection and privacy). Further details at https://doi.org/10.1016/S2352-4642(23)00316-4


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Funding

Funder referenceFunder name
Bill & Melinda Gates Foundation
Department for International Development
Health Data Research UK
MC_PC_19056
National Institute for Health Research
Medical Research Council Population Health Research Unit
NIHR Clinical Trials Unit Support Funding
NIHR Health Protection Unit in Emerging and Zoonotic Infections
NIHR Oxford Biomedical Research Centre
Wellcome
UK Research and Innovation

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