Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/30044
Title: Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY): statistical analysis plan for a randomised controlled Bayesian adaptive sample size trial.
Austin Authors: McGree, J M;Hockham, C;Kotwal, S;Wilcox, A;Bassi, A;Pollock, C;Burrell, L M;Snelling, T;Jha, V;Jardine, M;Jones, M
Affiliation: Medicine (University of Melbourne)
Kolling Institute of Medical Research, The University of Sydney, Sydney, Australia
Sydney School of Public Health, The University of Sydney, Sydney, Australia
The Sydney Children's Hospitals Network, Westmead, Australia
Concord Repatriation General Hospital, Sydney, Australia
The George Institute for Global Health, Imperial College London, London, UK
School of Mathematical Sciences, Queensland University of Technology, Brisbane, Australia
The George Institute for Global Health, University of New South Wales, Sydney, Australia
Prince of Wales Hospital, Sydney, Australia
NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia
Royal North Shore Hospital, Sydney, Australia
The George Institute for Global Health, New Delhi, India
Issue Date: 27-Apr-2022
Date: 2022
Publication information: Trials 2022; 23(1): 361
Abstract: The CLARITY trial (Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease) is a two-arm, multi-centre, randomised controlled trial being run in India and Australia that investigates the effectiveness of angiotensin receptor blockers in addition to standard care compared to placebo (in Indian sites) with standard care in reducing the duration and severity of lung failure in patients with COVID-19. The trial was designed as a Bayesian adaptive sample size trial with regular planned analyses where pre-specified decision rules will be assessed to determine whether the trial should be stopped due to sufficient evidence of treatment effectiveness or futility. Here, we describe the statistical analysis plan for the trial and define the pre-specified decision rules, including those that could lead to the trial being halted. The primary outcome is clinical status on a 7-point ordinal scale adapted from the WHO Clinical Progression scale assessed at day 14. The primary analysis will follow the intention-to-treat principle. A Bayesian adaptive trial design was selected because there is considerable uncertainty about the extent of potential benefit of this treatment.Trial registrationClinicalTrials.gov NCT04394117 . Registered on 19 May 2020Clinical Trial Registry of India CTRI/2020/07/026831Version and revisionsVersion 1.0. No revisions.
URI: https://ahro.austin.org.au/austinjspui/handle/1/30044
DOI: 10.1186/s13063-022-06167-2
ORCID: 0000-0003-4128-1796
0000-0003-1863-7539
Journal: Trials
PubMed URL: 35477480
PubMed URL: https://pubmed.ncbi.nlm.nih.gov/35477480/
Type: Journal Article
Subjects: Adaptive sample size
Angiotensin receptor blockers
Bayesian design
Clinical trial
Coronavirus
Protocol
Statistical analysis plan
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