Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY): statistical analysis plan for a randomised controlled Bayesian adaptive sample size trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 23; no. 1; p. 361
• Main 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
• Format: Journal Article
• Language: English
• Published: England BioMed Central 27.04.2022; BMC
• Subjects: Adaptive sample size; Angiotensin Receptor Antagonists - adverse effects; Angiotensin receptor blockers; Bayes Theorem; Bayesian design; Clinical trial; Coronavirus; COVID-19; COVID-19 Drug Treatment; Data Interpretation, Statistical; Disease transmission; Enrollments; Hospitals; Humans; Infections; Missing data; Pandemics; Protocol; Respiratory diseases; Respiratory Tract Diseases; Sample Size; Severe acute respiratory syndrome coronavirus 2; Statistical analysis; Study Protocol; Australia; India; Coronavirus; Statistical analysis plan; Angiotensin receptor blockers; Clinical trial; Bayesian design; Protocol; Adaptive sample size
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-06167-2

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.