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Article History

Received: 11 December 2022

Accepted: 30 January 2023

First Online: 13 March 2023

Declarations

:

: Ethics committee approval was received from the South Central - Berkshire Research Ethics Committee (REC reference: 20/SC/0403) on 23/10/2020. Written, informed consent to participate will be obtained from all participants enrolled in the PROTECT-V trial

: On completion of each intervention of the trial, the data will be analysed and tabulated and an Intervention-Specific Final Trial Report prepared. The results of this trial may be published or presented at scientific meetings. Authorship of final trial outputs will be assigned and funding acknowledged in accordance with the guidelines set out by the International Committee of Medical Journal Editors.All manuscripts or abstracts which present data from the niclosamide arm of the trial will be made available for review by UNION Therapeutics before submission and manuscripts or abstracts relating to sotrovimab to GlaxoSmithKline Plc and Vir Biotechnology Inc. This is to protect proprietary information and to provide comments.

: TJLH has received research funding from AstraZeneca outside of the submitted work. RS receives research funding from UNION Therapeutics and GSK. DD and MCX receive research funding from GSK. DD has also received honoraria from AstraZeneca, Boehringer Ingelheim and Gilead Sciences. TFH is an employee of GSK (but has no involvement in the sotrovimab arm of the study). TFH designed the core protocol and niclosamide arm of the trial with RS. VJ has received grant funding from GSK, Baxter Healthcare and Biocon and honoraria from Bayer, AstraZeneca, Boehringer Ingelheim, NephroPlus and Zydus Cadilla, under the policy of all honoraria being paid to the organisation.