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Authors
Serigstad, Sondre
Ritz, Christian
Faurholt-Jepsen, Daniel
Markussen, Dagfinn
Ebbesen, Marit H.
Kommedal, Øyvind
Bjørneklett, Rune O.
Heggelund, Lars
Clark, Tristan W.
van Werkhoven, Cornelis H.
Knoop, Siri T.
Ulvestad, Elling
Grewal, Harleen M. S. https://orcid.org/0000-0002-3380-1117
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Bjørneklett, R.
Clark, T. W.
Ebbesen, M.
Faurholt-Jepsen, D.
Grewal, H. M. S.
Heggelund, L.
Knoop, S. T.
Kommedal, Ø.
Markussen, D.
Ravn, P.
Ritz, C.
Serigstad, S.
Ulvestad, E.
Van Werkhoven, C. H.
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Funding
Funding for this research was provided by:
Research Council of Norway (NORCAP; 288718)
The Trond Mohn Foundation (COVID-19 CAPNOR; TMS2020TMT07 and RESPNOR; BFS2019TMT06)
The University of Bergen
Haukeland University Hospital
University of Bergen
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Article History
Received: 28 March 2022
Accepted: 9 June 2022
First Online: 1 August 2022
Declarations
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: The Regional Committee for Medical and Health Research Ethics in Southeast Norway approved the 3rd version of the protocol on 21 August 2020 (registration no.: 31935). Written informed consent is obtained from all participants or from their legal guardian/close relative at the time of recruitment.The RCT and nested studies will be conducted according to national and international requirements (the Declaration of Helsinki), Protection of Human Subjects (Title 21 in the Code of Federal Regulations (CFR), part 50), Institutional Review Boards (21 CFR, part 56), Obligations of Clinical Investigators (21 CFR, part 312) and Independent Ethics Committees. Moreover, the study will adhere to applicable ICH-GCP guidelines as well as any other relevant laws and regulations. To maintain confidentiality, any source documents, eCRFs, study reports, etc., will be maintained in a secured location. Ethical approval for the study and for biobanking of clinical samples has been obtained from REC as well as a waiver of consent to link patient data to death certificates. All patients are requested for written informed consent as well as for consent for the storage of samples at the Biobank in Bergen. The RCT has been registered with , with the identification number: NCT04660084.
: Not applicable.
: TWC has received speaker fees, honoraria, travel reimbursement and equipment and consumables at a discount or free of charge for the purposes independent of research, outside of this submitted study, from BioFire diagnostics, BioMérieux and QIAGEN. TWC has received consultancy fees from Cepheid, Synairgen research, Randox laboratories and Cidara therapeutics. He has received honoraria for participation in advisory boards and consultancy fees from Cepheid, Roche, Janssen and Shionogi. He is a member of independent data monitoring committees for trials sponsored by Roche. He has acted as the UK chief investigator for studies sponsored by Janssen. C. H. van Werkhoven has received non-financial and financial research support from BioMérieux outside this submitted study. The other authors have nothing to disclose.
