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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
787
Angiotensin Receptor Blockers (ARBs) have been in clinical use for more than 30 years for their cardiac and renal protective effects. ARBs mechanism of action is through selective inhibition of angiotensin-II (Ang-II) by competitive antagonism of the angiotensin receptor. ARBs displace ang-II from the angiotensin I receptor and produce their protective effects by reducing the downstream effects of ang-II induced vasoconstriction, aldosterone release, catecholamine release, arginine vasopressin release, water intake, and hypertrophic response The virus causing COVID-19, SARS-CoV-2, binds to the extracellular portion of Angiotensin-Converting-Enzyme-2 (ACE2) expressed on type II alveolar cells in the lungs which is followed by internalization of ACE2 before downregulating membrane ACE2 expression. Both these components appear to require angiotensin receptor Type 1 (AT1R), and ARBs, which block the actions of AT1R, would reduce the severity of COVID-19 and reduce the duration of symptoms
Placebo
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Canterbury Hospital
7-Point National Institute of Health Clinical Health Score
To determine whether the addition of the intervention, compared to standard care, changes the clinical health score of a participant on the following scale; 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 7. Death;
Time frame: 14 Days
7-Point National Institute of Health Clinical Health Score
To determine whether the addition of the intervention, compared to standard care, changes the clinical health score of a participant on the following scale; 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 7. Death;
Time frame: 28 Days
Mortality
To determine whether the addition of the intervention, compared to standard care, changes the risk of all cause mortality
Time frame: 28 Days
Mortality
To determine whether the addition of the intervention, compared to standard care, changes the risk of all cause mortality
Time frame: 90 Days
Intensive Care Unit Admission
To determine whether the addition of the intervention, compared to standard care, changes the count of all cause Intensive Care Unit admission
Time frame: 28 Days
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Campsie, New South Wales, Australia
The Sutherland Hospital
Caringbah, New South Wales, Australia
Concord Hospital
Concord, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
...and 12 more locations
Intensive Care Unit Admission
To determine whether the addition of the intervention, compared to standard care, changes the count of all cause Intensive Care Unit admission
Time frame: 90 Days
Intensive Care Unit Number of Days
To determine whether the addition of the intervention, compared to standard care, changes the number of days total, of intensive care unit admission
Time frame: 90 Days
Respiratory Failure
To determine whether the addition of the intervention, compared to standard care, changes the incidence of respiratory failure
Time frame: 28 Days
Dialysis Requirement
To determine whether the addition of the intervention, compared to standard care, changes the requirements for dialysis
Time frame: 28 Days
Hospitalisation Days
To determine whether the addition of the intervention, compared to standard care, changes the number of hospitalisation days
Time frame: 28 Days
Hospitalisation Days
To determine whether the addition of the intervention, compared to standard care, changes the number of hospitalisation days
Time frame: 90 Days
Ventilator-Free Days
To determine whether the addition of the intervention, compared to standard care, changes need for ventilation
Time frame: 28 Days
Dialysis Days
To determine whether the addition of the intervention, compared to standard care, changes need for dialysis
Time frame: 28 Days
Acute Kidney Injury
To determine whether the addition of the intervention, compared to standard care, changes risk of acute kidney injury, based on the Kidney Disease: Improving Global Outcomes definition
Time frame: 28 Days
Hypotension Requiring Vasopressors
To determine whether the addition of the intervention, compared to standard care, changes risk of hypotension requiring vasopressors
Time frame: 28 Days