McGree J M, Hockham C, Kotwal S, Wilcox A, Bassi A, Pollock C, Burrell L M, Snelling T, Jha V, Jardine M, Jones M
School of Mathematical Sciences, Queensland University of Technology, Brisbane, Australia.
The George Institute for Global Health, University of New South Wales, Sydney, Australia.
Trials. 2022 Apr 27;23(1):361. 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.
CLARITY试验（评估血管紧张素受体阻滞剂治疗COVID-19呼吸系统疾病）是一项双臂、多中心随机对照试验，在印度和澳大利亚开展，旨在研究与安慰剂（在印度的试验点）加标准治疗相比，血管紧张素受体阻滞剂加标准治疗在缩短COVID-19患者肺衰竭持续时间和减轻严重程度方面的有效性。该试验设计为贝叶斯适应性样本量试验，进行定期计划分析，将评估预先指定的决策规则，以确定是否应因有足够的治疗有效性或无效证据而停止试验。在此，我们描述该试验的统计分析计划，并定义预先指定的决策规则，包括那些可能导致试验停止的规则。主要结局是根据世界卫生组织临床进展量表改编的7分序数量表评估的第14天临床状态。主要分析将遵循意向性分析原则。选择贝叶斯适应性试验设计是因为这种治疗潜在益处的程度存在很大不确定性。试验注册ClinicalTrials.gov NCT04394117。于2020年5月19日注册印度临床试验注册中心CTRI/2020/07/026831版本及修订版本1.0。无修订。
