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

Angiotensin Receptor Antagonists / adverse effects Bayes Theorem Data Interpretation, Statistical Humans Respiratory Tract Diseases Sample Size COVID-19 Drug Treatment
Adaptive sample size Angiotensin receptor blockers Bayesian design Clinical trial Coronavirus Protocol Statistical analysis plan

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
27 Apr 2022
Historique:
received: 19 10 2021
accepted: 10 03 2022
entrez: 28 4 2022
pubmed: 29 4 2022
medline: 30 4 2022
Statut: epublish

Résumé

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.

Identifiants

DOI: 10.1186/s13063-022-06167-2 PMID: 35477480 PMC: PMC9044378
pubmed: 35477480
doi: 10.1186/s13063-022-06167-2
pii: 10.1186/s13063-022-06167-2
pmc: PMC9044378
doi:

Substances chimiques

Angiotensin Receptor Antagonists 0

Banques de données

ClinicalTrials.gov
['NCT04394117']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

361

Subventions

Organisme : National Health and Medical Research Council
ID : APP2002277

Informations de copyright

© 2022. The Author(s).

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Auteurs

J M McGree (JM)

School of Mathematical Sciences, Queensland University of Technology, Brisbane, Australia. james.mcgree@qut.edu.au.

C Hockham (C)

The George Institute for Global Health, University of New South Wales, Sydney, Australia.
The George Institute for Global Health, Imperial College London, London, UK.

S Kotwal (S)

The George Institute for Global Health, University of New South Wales, Sydney, Australia.
Prince of Wales Hospital, Sydney, Australia.

A Wilcox (A)

The George Institute for Global Health, University of New South Wales, Sydney, Australia.
NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia.
ORCID: 0000-0003-4128-1796

A Bassi (A)

The George Institute for Global Health, New Delhi, India.

C Pollock (C)

Royal North Shore Hospital, Sydney, Australia.
Kolling Institute of Medical Research, The University of Sydney, Sydney, Australia.

L M Burrell (LM)

Department of Medicine, The University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.

T Snelling (T)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.
The Sydney Children's Hospitals Network, Westmead, Australia.

V Jha (V)

The George Institute for Global Health, University of New South Wales, Sydney, Australia.
The George Institute for Global Health, New Delhi, India.

M Jardine (M)

The George Institute for Global Health, University of New South Wales, Sydney, Australia.
NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia.
Concord Repatriation General Hospital, Sydney, Australia.

M Jones (M)

Sydney School of Public Health, The University of Sydney, Sydney, Australia.

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Classifications MeSH

questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Mécanismes moléculaires de l'action pharmacologique › Antagonistes des récepteurs aux angiotensines › Controlled evaLuation of Angiotensin Receptor...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Statistiques comme sujet › Probabilité › Théorème de Bayes › Controlled evaLuation of Angiotensin Receptor...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Statistiques comme sujet › Interprétation statistique de données › Controlled evaLuation of Angiotensin Receptor...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Controlled evaLuation of Angiotensin Receptor...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Controlled evaLuation of Angiotensin Receptor...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Taille de l'échantillon › Controlled evaLuation of Angiotensin Receptor...
questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Traitements médicamenteux de la COVID-19 › Controlled evaLuation of Angiotensin Receptor...