Gorman, Ellen
Shankar-Hari, Manu
Hopkins, Phil
Tunnicliffe, William S.
Perkins, Gavin D.
Silversides, Jonathan
McGuigan, Peter
Jackson, Colette
Boyle, Roisin
McFerran, Jamie
McDowell, Cliona
Campbell, Christina
McFarland, Margaret
Smythe, Jon
Thompson, Jacqui
Williams, Barry
Curley, Gerard
Laffey, John G.
Clarke, Mike
McAuley, Daniel F.
O’Kane, Cecilia
Funding for this research was provided by:
public health agency research and development division northern ireland
wellcome trust (106939/Z/15/Z)
Article History
Received: 23 June 2021
Accepted: 26 March 2022
First Online: 13 May 2022
Declarations
:
: This trial has received ethics approval from the REC (North East York REC). Reference 18/NE/006. Favourable opinion was received on 6 February 2018. REC approval for amended protocol (v6.0 30.09.2020) was received on 13 October 2020. Informed consent will be obtained for all participants.
: Not applicable.
: EG receives funding by the Wellcome Trust Health Innovation Challenge Fund [reference 106939/Z/15/Z] for the described work. COK, DMcA, JL and JS are investigators on the grant funding this work from Wellcome Trust Health Innovation Challenge Fund [reference 106939/Z/15/Z]. DMcA, COK and MC are investigators on a grant received from the Northern Ireland Health and Social Care Research and Development Division to fund an additional COVID-19 cohort during phase 2 of the REALIST trial<b>.</b> JL reports consulting fees from Baxter Healthcare and GlaxoSmithKline, provision of medicolegal reports to the Irish Clinical Indemnity Scheme, participation in DSMB for other clinical trials and is named on a patent for InspireShield, a device to reduce COVID-19 spread. MSH is supported by a NIHR Clinician Scientist Fellowship (CS- 2016-16-011). GDP is supported by the Health Research (NIHR) Applied Research Collaboration (ARC) West Midlands and is a director of research for the Intensive Care Society. GC reports grants from Health Research Board (Ireland) Emerging Clinician Scientist Award and the United States Department of Defense Discovery Award. DMcA reports grants from NIHR, Innovate UK, MRC and Novavax as an investigator in ARDS and COVID-19 studies. DMcA reports consultancy fees unrelated to this work from Bayer, GlaxoSmithKline, Boehringer Ingelheim<b>,</b> Novartis and Eli Lilly. DMcA reports payments from GlaxoSmithKline as an educational seminar speaker. DMcA is a member of the DSMB for Vir Biotechnology, Inc., and Faron Pharmaceuticals. DMcA has a patent for a novel treatment for inflammatory disease. DMcA is a director of research for the Intensive Care Society and Director of the EME programme for MRC/NIHR. DMcA reports a spouse who has received consultancy fees from INSMED and from the California Institute for Regenerative unrelated to this clinical trial. COK has received consultancy fees from INSMED, unrelated to this work, and fees for participation in grant panels for the Californian Institute of Regenerative Medicine, unrelated to this clinical trial. COK reports a spouse who has received grants from NIHR, Innovate UK, MRC and Novavax. COK reports a spouse who has received consultancy fees unrelated to this work from Bayer, GlaxoSmithKline, Boehringer Ingelheim, Novartis and Eli Lilly. COK reports a spouse who has received payments from GlaxoSmithKline as an educational seminar speaker. COK reports a spouse who is a member of the DSMB for Vir Biotechnology, Inc., and Faron Pharmaceuticals. COK reports a spouse who has a patent for a novel treatment for inflammatory disease. COK reports a spouse who is a director of research for the Intensive Care Society and Director of the EME programme for MRC/NIHR. All other authors report no declarations of interest. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the National Institute for Health Research (NIHR) or the Department of Health and Social Care.