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.
Keywords: Adaptive sample size; Angiotensin receptor blockers; Bayesian design; Clinical trial; Coronavirus; Protocol; Statistical analysis plan.
【저자키워드】 coronavirus, clinical trial, protocol, Angiotensin receptor blockers, Adaptive sample size, Bayesian design, Statistical analysis plan., 【초록키워드】 COVID-19, randomised controlled trial, Bayesian, Trial, adaptive, severity, India, clinical status, clinical, Effectiveness, Placebo, Statistical analysis plan, receptor, registry, disease, CLARITY, angiotensin receptor blocker, Evidence, angiotensin, Treatment effectiveness, Sample size, Primary outcome, standard care, 7-point ordinal scale, intention-to-treat principle, primary analysis, blocker, Two-arm, lung failure, benefit, addition, determine, reducing, analysis, the WHO, Controlled, analysis plan, patients with COVID-19, was selected, 【제목키워드】 COVID-19, Bayesian, Trial, adaptive, Statistical analysis plan, disease, angiotensin, Sample size, blocker, Controlled, randomised controlled,