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

被引：4

作者：

McGree, J. M. ^{[1
]}

Hockham, C. ^{[2
,3
]}

Kotwal, S. ^{[2
,4
]}

Wilcox, A. ^{[2
,5
]}

Bassi, A. ^{[6
]}

Pollock, C. ^{[7
,8
]}

Burrell, L. M. ^{[9
]}

Snelling, T. ^{[10
,11
]}

Jha, V. ^{[2
,6
]}

Jardine, M. ^{[2
,5
]}

Jones, M. ^{[10
,12
]}

机构：

[1] Queensland Univ Technol, Sch Math Sci, Brisbane, Qld, Australia

[2] Univ New South Wales, George Inst Global Hlth, Sydney, NSW, Australia

[3] Imperial Coll London, George Inst Global Hlth, London, England

[4] Prince Wales Hosp, Sydney, NSW, Australia

[5] Univ Sydney, NHMRC Clin Trials Ctr, Sydney, NSW, Australia

[6] George Inst Global Hlth, New Delhi, India

[7] Royal North Shore Hosp, Sydney, NSW, Australia

[8] Univ Sydney, Kolling Inst Med Res, Sydney, NSW, Australia

[9] Univ Melbourne, Dept Med, Austin Hlth, Heidelberg, Vic, Australia

[10] Univ Sydney, Sydney Sch Publ Hlth, Sydney, NSW, Australia

[11] Sydney Childrens Hosp Network, Westmead, NSW, Australia

[12] Concord Repatriat Gen Hosp, Sydney, NSW, Australia

来源：

TRIALS | 2022年 / 23卷 / 01期

关键词：

Adaptive sample size; Angiotensin receptor blockers; Bayesian design; Clinical trial; Coronavirus; Protocol; Statistical analysis plan; ACE2; GUIDELINES; MODEL;

D O I：

10.1186/s13063-022-06167-2

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页数：18

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