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

  • STATUS
    Recruiting
  • participants needed
    605
  • sponsor
    The George Institute
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Updated on 1 February 2023
See if I qualify
cardiovascular disease
immunosuppression
angiotensin
respiratory disorder
angiotensin receptor blockers
covid-19
hemoglobin a1c
SARS
acute respiratory syndrome (sars)

Summary

The Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY) study is a pragmatic prospective, open-label, randomised controlled trial. CLARITY aims to examine the effectiveness of angiotensin II receptor blockers (ARBs) on improving the outcomes of people who tested positive for COVID-19 disease.

Details
Condition Covid 19, SARS-Cov-2
Age 18years - 100years
Treatment Angiotensin Receptor Blockers
Clinical Study IdentifierNCT04394117
SponsorThe George Institute
Last Modified on1 February 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

b'Potential participants must satisfy all of the following:'
b'Laboratory-confirmed diagnosis of SARS-CoV-2 infection'
b'Age \\u2265 18 years'
b'a) Systolic Blood Pressure (SBP) \\u2265 125 mmHg OR b) SBP \\u2265 115 mmHg and currently treated'
b'with a non-RAASi Blood Pressure (BP) lowering agent that can be ceased'
b'Participant and treating staff are willing and able to perform trial procedures.'
b'Either Intended for hospital admission for management of COVID-19, or'
b'Intended for management at home with one or more of the following criteria:'
b'Age\\u226560 years'
b"BMI \\u226530kg/m2 (derived from the patient's self report of their height and weight"
b'where these are not measured directly)'
b'Diagnosis of diabetes with HbA1c \\u22657% or on glucose lowering medication'
b'History of cardiovascular disease'
b'History of chronic respiratory illness'
b'Currently treated with immunosuppression'
b'a) For those intended for hospital admission, the diagnosis (i.e. date of test result)'
b'for SARS-CoV-2 infection must be within 3 days prior to randomisation, OR b) For those'
b'intended for management at home, the diagnosis (i.e. date of test result) for'
b'SARS-CoV-2 infection must be within 7 days prior to randomisation'

Exclusion Criteria

b'Currently treated with an ACEi, ARB or aldosterone antagonist, aliskeren, or'
b'angiotensin receptor-neprilysin inhibitors (ARNi)'
b'Serum potassium > 5.2 mmol/L or no potassium testing within the last 3 months'
b'a) For those intended for hospital admission, an estimated Glomerular Filtration Rate'
b'(eGFR) <30ml/min/1.732 or no eGFR testing within the last 3 months, OR b) For those'
b'intended for management at home, an eGFR <45ml/min/1.732 or no eGFR testing within the'
b'last 3 months'
b'Known symptomatic postural hypotension'
b'Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score'
b'10-15) - see Table below'
b'Intolerance of ARB'
b'Women younger than 51 years who have not had a negative pregnancy test during the past'
b'3 days'
b'Women younger than 51 years who do not agree to use adequate contraception'
b'Women who are currently breastfeeding'
b'Individuals who are not able to take medications by mouth at enrolment, or who are not'
b'expected to be able to take medications by mouth during the first 48 hours after'
b'randomisation'
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hemoglobin a1c
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acute respiratory syndrome (sars)

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