Evidence map›Paper›PMID 35477480›Full record

ArticleTrials2022

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

J M McGree, C Hockham, S Kotwal, A Wilcox, A Bassi, C Pollock, L M Burrell, T Snelling, V Jha, M Jardine and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04394117 (Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 45% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04394117 phase4completednot on this map

Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease

TypeinterventionalSponsorThe George InstituteRan2020 to 2022Enrolled787ConditionsCoronavirus Disease 2019, COVID-19ArmsAngiotensin Receptor Blockers, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Being Bayesian in the 2020s: opportunities and challenges in the practice of modern applied Bayesian statistics.Philosophical transactions. Series A, Mathematical, physical, and engineering sciences · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 3 countries.

J M McGreeSchool of Mathematical Sciences, Queensland University of Technology, Brisbane, Australia. james.mcgree@qut.edu.au.
C HockhamThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
S KotwalThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
A WilcoxThe George Institute for Global Health, University of New South Wales, Sydney, Australia.ORCID http://orcid.org/0000-0003-4128-1796
A BassiThe George Institute for Global Health, New Delhi, India.
C PollockRoyal North Shore Hospital, Sydney, Australia.
L M BurrellDepartment of Medicine, The University of Melbourne, Austin Health, Heidelberg, Victoria, Australia.
T SnellingSydney School of Public Health, The University of Sydney, Sydney, Australia.
V JhaThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
M JardineThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
M JonesSydney School of Public Health, The University of Sydney, Sydney, Australia.
CLARITY Trial Steering Committee
The University of Sydney · AUUNSW Sydney · AUGeorge Institute for Global Health · INQueensland University of Technology · AUThe George Institute for Global Health · GBThe University of Melbourne · AU

Funding

National Health and Medical Research Council APP2002277
6 · The paper itself

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.

Indexed as

COVID-19 Drug TreatmentRespiratory Tract DiseasesAdaptive Clinical Trials as TopicAngiotensin Receptor AntagonistsBayes TheoremData Interpretation, StatisticalHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicSample SizeAngiotensin Receptor AntagonistsAdaptive sample sizeAngiotensin receptor blockersBayesian designClinical trialCoronavirusProtocolStatistical analysis plan

Identifiers

PMID35477480
PMCPMC9044378
OpenAlexW4225277841

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.