Evidence map›Paper›PMID 34454580›Full record

ArticleTrials2021

Protocol for the Controlled evaLuation of Angiotensin Receptor blockers for COVID-19 respIraTorY disease (CLARITY): a randomised controlled trial.

Carinna Hockham, Sradha Kotwal, Arlen Wilcox, Abhinav Bassi, James McGree, Carol Pollock, Louise M Burrell, Nikita Bathla, Mallikarjuna Kunigari, Vinay Rathore and 10 more

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

Article in Trials, 2021. 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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.6field-weighted citation impact, top 30% 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

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. COVID-19 and cardiovascular disease in patients with chronic kidney disease.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2024
    Review
  3. Review
  4. Review
  5. Article
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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

20 authors at 9 institutions in 3 countries.

Carinna Hockham *The George Institute for Global Health, University of New South Wales, Sydney, Australia.
Sradha Kotwal *The George Institute for Global Health, University of New South Wales, Sydney, Australia.
Arlen WilcoxThe George Institute for Global Health, University of New South Wales, Sydney, Australia. arlen.wilcox@sydney.edu.au.ORCID http://orcid.org/0000-0003-4128-1796
Abhinav BassiThe George Institute for Global Health, New Delhi, India.
James McGreeQueensland University of Technology, Brisbane, Australia.
Carol PollockRoyal North Shore Hospital, Sydney, Australia.
Louise M BurrellDepartment of Medicine, The University of Melbourne, Austin Health, Heidelburg, Victoria, Australia.
Nikita BathlaThe George Institute for Global Health, New Delhi, India.
Mallikarjuna KunigariThe George Institute for Global Health, New Delhi, India.
Vinay RathoreAll India Institute of Medical Sciences, Raipur, India.
Michael JohnChristian Medical College, Ludhiana, India.
Enmoore LinThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
Christine JenkinsThe George Institute for Global Health, University of New South Wales, Sydney, Australia.
Angus RitchieConcord Repatriation General Hospital, Sydney, Australia.
Andrew McLachlanConcord Repatriation General Hospital, Sydney, Australia.
Thomas SnellingSydney School of Public Health, University of Sydney, Sydney, Australia.
Mark JonesSydney School of Public Health, University of Sydney, Sydney, Australia.
Vivekanand Jha *The George Institute for Global Health, University of New South Wales, Sydney, Australia.
Meg Jardine *The George Institute for Global Health, University of New South Wales, Sydney, Australia.
CLARITY Investigators
The University of Sydney · AUGeorge Institute for Global Health · INUNSW Sydney · AUConcord Repatriation General Hospital · AUAll India Institute of Medical Sciences Raipur · INChristian Medical College, Vellore · 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

backgroundSARS-CoV-2 binds to membrane-bound angiotensin-converting enzyme 2 (ACE2) which may result in downregulation of membrane-bound ACE2. ACE2 is a key regulator of the renin-angiotensin system (RAS) and is responsible for degrading angiotensin II and thereby counteracting its pro-inflammatory, pro-fibrotic effects mediated through the angiotensin II type 1 receptor (AT1R). As AT1R is directly blocked by angiotensin receptor blockers (ARBs), these agents may offer a safe, low-cost solution for reducing COVID-19 respiratory outcomes. METHODS AND DISCUSSION: CLARITY is a pragmatic, adaptive, two-arm, multi-centre, comparative effectiveness phase III randomised controlled trial that examines whether ARBs reduce COVID-19 severity among high-risk patients. Recruiting in India and Australia, the trial will compare treatment with a maximum tolerated daily dose of an ARB to standard of care. Treatment allocation is blinded in India but open-label in Australia due to interruptions to placebo supply in the latter. The primary endpoint is a 7-point ordinal scale of clinical states, ranging from no limitation of activities (category 1) to death (category 7), assessed on day 14. Secondary outcomes include the 7-point scale assessed at day 28 and 28- and 90-day mortality. The design adapts the sample size based on accumulating data via frequent interim analyses and the use of predictive probability to determine whether the current sample size is sufficient or continuing accrual would be futile. The trial commenced recruitment on 18 August 2020.

trial registrationClinicalTrials.gov, NCT04394117 . Registered on 19 May 2020. Clinical Trial Registry of India: CTRI/2020/07/026831).

Indexed as

Angiotensin Receptor AntagonistsCOVID-19Angiotensin-Converting Enzyme InhibitorsHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicRenin-Angiotensin SystemSARS-CoV-2Angiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsAngiotensin receptor blockersBayesian adaptive designCOVID-19RCTRenin-angiotensin system

Identifiers

PMID34454580
PMCPMC8397850
OpenAlexW3197407163

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.