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Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY): statistical analysis plan for a randomised controlled Bayesian adaptive sample size trial.
McGree, J M; Hockham, C; Kotwal, S; Wilcox, A; Bassi, A; Pollock, C; Burrell, L M; Snelling, T; Jha, V; Jardine, M; Jones, M.
  • McGree JM; School of Mathematical Sciences, Queensland University of Technology, Brisbane, Australia. james.mcgree@qut.edu.au.
  • Hockham C; The George Institute for Global Health, University of New South Wales, Sydney, Australia.
  • Kotwal S; The George Institute for Global Health, Imperial College London, London, UK.
  • Wilcox A; The George Institute for Global Health, University of New South Wales, Sydney, Australia.
  • Bassi A; Prince of Wales Hospital, Sydney, Australia.
  • Pollock C; The George Institute for Global Health, University of New South Wales, Sydney, Australia.
  • Burrell LM; NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia.
  • Snelling T; The George Institute for Global Health, New Delhi, India.
  • Jha V; Royal North Shore Hospital, Sydney, Australia.
  • Jardine M; Kolling Institute of Medical Research, The University of Sydney, Sydney, Australia.
  • Jones M; Department of Medicine, The University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.
Trials ; 23(1): 361, 2022 Apr 27.
Article in English | MEDLINE | ID: covidwho-1817238
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Tract Diseases / COVID-19 Drug Treatment Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06167-2

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Tract Diseases / COVID-19 Drug Treatment Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06167-2