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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2021
  • participants needed
    605
  • sponsor
    The George Institute
Updated on 23 July 2020
Investigator
Meg Jardine, MBBS
Primary Contact
Concord Hospital (4.4 mi away) Contact
+10 other location
diabetes
angiotensin
covid-19
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
Treatment Angiotensin Receptor Blockers, Angiotensin Receptor Blockers
Clinical Study IdentifierNCT04394117
SponsorThe George Institute
Last Modified on23 July 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Covid-19 or SARS-Cov-2 or *COVID-19?
Potential participants must satisfy all of the following
Laboratory-confirmed diagnosis of SARS-CoV-2 infection
Age 18 years
a) Systolic Blood Pressure (SBP) 125 mmHg OR b) SBP 115 mmHg and currently treated with a non-RAASi Blood Pressure (BP) lowering agent that can be ceased
Participant and treating staff are willing and able to perform trial procedures
Either Intended for hospital admission for management of COVID-19, or
Intended for management at home with one or more of the following criteria
Age60 years
BMI 30kg/m2 (derived from the patient's self report of their height and weight where these are not measured directly)
Diagnosis of diabetes with HbA1c 7% or on glucose lowering medication
History of cardiovascular disease
History of chronic respiratory illness
Currently treated with immunosuppression
a) For those intended for hospital admission, the diagnosis (i.e. date of test result) for SARS-CoV-2 infection must be within 3 days prior to randomisation, OR b) For those intended for management at home, the diagnosis (i.e. date of test result) for SARS-CoV-2 infection must be within 7 days prior to randomisation

Exclusion Criteria

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