Published in:
Open Access
01-12-2022 | COVID-19 | Study protocol
Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY): statistical analysis plan for a randomised controlled Bayesian adaptive sample size trial
Authors:
J. M. McGree, C. Hockham, S. Kotwal, A. Wilcox, A. Bassi, C. Pollock, L. M. Burrell, T. Snelling, V. Jha, M. Jardine, M. Jones, for the CLARITY Trial Steering Committee
Published in:
Trials
|
Issue 1/2022
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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 registration
ClinicalTrials.gov
NCT04394117. Registered on 19 May 2020Clinical Trial Registry of India CTRI/2020/07/026831
Version and revisions
Version 1.0. No revisions.