Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/27444
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dc.contributor.authorHockham, Carinna-
dc.contributor.authorKotwal, Sradha-
dc.contributor.authorWilcox, Arlen-
dc.contributor.authorBassi, Abhinav-
dc.contributor.authorMcGree, James-
dc.contributor.authorPollock, Carol-
dc.contributor.authorBurrell, Louise M-
dc.contributor.authorBathla, Nikita-
dc.contributor.authorKunigari, Mallikarjuna-
dc.contributor.authorRathore, Vinay-
dc.contributor.authorJohn, Michael-
dc.contributor.authorLin, Enmoore-
dc.contributor.authorJenkins, Christine-
dc.contributor.authorRitchie, Angus-
dc.contributor.authorMcLachlan, Andrew-
dc.contributor.authorSnelling, Thomas-
dc.contributor.authorJones, Mark-
dc.contributor.authorJha, Vivekanand-
dc.contributor.authorJardine, Meg-
dc.date2021-
dc.date.accessioned2021-09-06T06:15:56Z-
dc.date.available2021-09-06T06:15:56Z-
dc.date.issued2021-08-28-
dc.identifier.citationTrials 2021; 22(1): 573en
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/27444-
dc.description.abstractSARS-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. 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. ClinicalTrials.gov, NCT04394117 . Registered on 19 May 2020. Clinical Trial Registry of India: CTRI/2020/07/026831).en
dc.language.isoeng-
dc.subjectAngiotensin receptor blockersen
dc.subjectBayesian adaptive designen
dc.subjectCOVID-19en
dc.subjectRCTen
dc.subjectRenin-angiotensin systemen
dc.titleProtocol for the Controlled evaLuation of Angiotensin Receptor blockers for COVID-19 respIraTorY disease (CLARITY): a randomised controlled trial.en
dc.typeJournal Articleen
dc.identifier.journaltitleTrialsen
dc.identifier.affiliationThe George Institute for Global Health, Imperial College London, London, UKen
dc.identifier.affiliationThe Sydney Children's Hospitals Network, Westmead, NSW, Australiaen
dc.identifier.affiliationThe George Institute for Global Health, New Delhi, Indiaen
dc.identifier.affiliationPrince of Wales Hospital, Sydney, Australiaen
dc.identifier.affiliationRoyal North Shore Hospital, Sydney, Australiaen
dc.identifier.affiliationKolling Institute of Medical Research, University of Sydney, Sydney, Australiaen
dc.identifier.affiliationThe University of Sydney, Sydney, Australiaen
dc.identifier.affiliationThe George Institute for Global Health, University of New South Wales, Sydney, Australiaen
dc.identifier.affiliationNHMRC Clinical Trials Centre, University of Sydney, Sydney, Australiaen
dc.identifier.affiliationQueensland University of Technology, Brisbane, Australiaen
dc.identifier.affiliationMedicine (University of Melbourne)en
dc.identifier.affiliationConcord Repatriation General Hospital, Sydney, Australiaen
dc.identifier.affiliationSydney School of Public Health, University of Sydney, Sydney, Australiaen
dc.identifier.affiliationThe George Institute for Global Health, New Delhi, Indiaen
dc.identifier.affiliationAll India Institute of Medical Sciences, Raipur, Indiaen
dc.identifier.affiliationChristian Medical College, Ludhiana, Indiaen
dc.identifier.doi10.1186/s13063-021-05521-0en
dc.type.contentTexten
dc.identifier.orcid0000-0003-4128-1796en
dc.identifier.pubmedid34454580-
local.name.researcherBurrell, Louise M
item.languageiso639-1en-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.openairetypeJournal Article-
crisitem.author.deptCardiology-
crisitem.author.deptGeneral Medicine-
crisitem.author.deptMedicine (University of Melbourne)-
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