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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04394117
Registration number
NCT04394117
Ethics application status
Date submitted
18/05/2020
Date registered
19/05/2020
Titles & IDs
Public title
Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease
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Scientific title
Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease
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Secondary ID [1]
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11052020
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Universal Trial Number (UTN)
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Trial acronym
CLARITY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronavirus Disease 2019
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COVID-19
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Angiotensin Receptor Blockers
Other interventions - Placebo
Active comparator: Standard Care + Angiotensin Receptor Blocker (ARB) - Participants will receive an Angiotensin Receptor Blocker on top of the standard care provided by their institution.
Placebo comparator: Standard Care + Placebo - Participants will receive a placebo on top of the standard care provided by their institution.
Treatment: Drugs: Angiotensin Receptor Blockers
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
Other interventions: Placebo
Placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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7-Point National Institute of Health Clinical Health Score
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Assessment method [1]
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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;
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Timepoint [1]
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14 Days
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Secondary outcome [1]
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7-Point National Institute of Health Clinical Health Score
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Assessment method [1]
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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;
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Timepoint [1]
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28 Days
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Secondary outcome [2]
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Mortality
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Assessment method [2]
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To determine whether the addition of the intervention, compared to standard care, changes the risk of all cause mortality
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Timepoint [2]
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28 Days
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Secondary outcome [3]
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Mortality
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Assessment method [3]
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To determine whether the addition of the intervention, compared to standard care, changes the risk of all cause mortality
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Timepoint [3]
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90 Days
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Secondary outcome [4]
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Intensive Care Unit Admission
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Assessment method [4]
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To determine whether the addition of the intervention, compared to standard care, changes the count of all cause Intensive Care Unit admission
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Timepoint [4]
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28 Days
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Secondary outcome [5]
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Intensive Care Unit Admission
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Assessment method [5]
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To determine whether the addition of the intervention, compared to standard care, changes the count of all cause Intensive Care Unit admission
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Timepoint [5]
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90 Days
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Secondary outcome [6]
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Intensive Care Unit Number of Days
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Assessment method [6]
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To determine whether the addition of the intervention, compared to standard care, changes the number of days total, of intensive care unit admission
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Timepoint [6]
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90 Days
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Secondary outcome [7]
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Respiratory Failure
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Assessment method [7]
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To determine whether the addition of the intervention, compared to standard care, changes the incidence of respiratory failure
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Timepoint [7]
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28 Days
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Secondary outcome [8]
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Dialysis Requirement
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Assessment method [8]
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To determine whether the addition of the intervention, compared to standard care, changes the requirements for dialysis
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Timepoint [8]
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28 Days
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Secondary outcome [9]
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Hospitalisation Days
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Assessment method [9]
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To determine whether the addition of the intervention, compared to standard care, changes the number of hospitalisation days
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Timepoint [9]
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28 Days
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Secondary outcome [10]
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Hospitalisation Days
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Assessment method [10]
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To determine whether the addition of the intervention, compared to standard care, changes the number of hospitalisation days
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Timepoint [10]
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90 Days
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Secondary outcome [11]
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Ventilator-Free Days
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Assessment method [11]
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To determine whether the addition of the intervention, compared to standard care, changes need for ventilation
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Timepoint [11]
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28 Days
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Secondary outcome [12]
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Dialysis Days
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Assessment method [12]
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To determine whether the addition of the intervention, compared to standard care, changes need for dialysis
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Timepoint [12]
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28 Days
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Secondary outcome [13]
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Acute Kidney Injury
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Assessment method [13]
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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
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Timepoint [13]
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28 Days
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Secondary outcome [14]
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Hypotension Requiring Vasopressors
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Assessment method [14]
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To determine whether the addition of the intervention, compared to standard care, changes risk of hypotension requiring vasopressors
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Timepoint [14]
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28 Days
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Eligibility
Key inclusion criteria
Potential participants must satisfy all of the following:
1. Laboratory-confirmed* diagnosis of Severe Acute Respiratory Syndrome-Coronavirus-2 infection within 10 days prior to randomisation
2. Age = 18 years
3. a) Systolic Blood Pressure (SBP) = 120 mmHg OR b) SBP = 115 mmHg and currently treated with a non-Renin Angiotensin Aldosterone System inhibitor Blood Pressure (BP) lowering agent that can be ceased
4. Participant and treating clinician are willing and able to perform trial procedures.
5. Either Intended for hospital admission for management of COVID-19, or (In Australia Only) Intended for management at home with one or more of the following criteria:
1. Age=60 years
2. Body Mass Index =30kg/m2 (derived from the patient's self-report of their height and weight where these are not measured directly)
3. Diagnosis of diabetes defined as HbA1c =7% and/or the consumption of glucose lowering medication
4. History of cardiovascular disease
5. History of chronic respiratory illness
6. Currently treated with immunosuppression
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Currently treated with an angiotensin-converting enzyme inhibitor, Angiotensin Receptor Blocker or aldosterone antagonist, aliskiren, or angiotensin receptor-neprilysin inhibitors (ARNi)
2. Serum potassium > 5.2 mmol/L or no potassium testing within the last 3 months
3. For those intended for hospital admission, an estimated Glomerular Filtration Rate (eGFR) <30ml/min/1.73m2 or no eGFR testing within the last 3 months, or For those intended for management at home (Australia only), an eGFR <45ml/min/1.73m2 or no eGFR testing within the last 3 months
4. Known symptomatic postural hypotension
5. Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15) - see Table below
6. Intolerance of ARB
7. Pregnancy or risk of pregnancy, defined as;
1. (In Australia only) Women younger than 51 years who have not had a negative pregnancy test during the past 3 days and/or who do not agree to use adequate contraception
2. (In India Only) Women who are pregnant
8. Women who are currently breastfeeding
9. 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
17/01/2022
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Sample size
Target
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Accrual to date
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Final
787
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Canterbury Hospital - Campsie
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Recruitment hospital [3]
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The Sutherland Hospital - Caringbah
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Recruitment hospital [4]
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Concord Hospital - Concord
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Recruitment hospital [5]
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St George Hospital - Kogarah
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Recruitment hospital [6]
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Liverpool Hospital - Liverpool
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Recruitment hospital [7]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [8]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [9]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [10]
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Westmead Hospital - Westmead
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Recruitment hospital [11]
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Wollongong Hospital - Wollongong
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Recruitment hospital [12]
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Northern Health - Epping
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Recruitment hospital [13]
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Austin Health - Heidelberg
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Recruitment hospital [14]
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Alfred Health - Melbourne
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Recruitment hospital [15]
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Western Health - St Albans
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2194 - Campsie
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Recruitment postcode(s) [3]
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2229 - Caringbah
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Recruitment postcode(s) [4]
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2139 - Concord
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Recruitment postcode(s) [5]
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2217 - Kogarah
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Recruitment postcode(s) [6]
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2170 - Liverpool
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Recruitment postcode(s) [7]
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2305 - New Lambton Heights
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Recruitment postcode(s) [8]
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2031 - Randwick
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Recruitment postcode(s) [9]
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2065 - St Leonards
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Recruitment postcode(s) [10]
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2145 - Westmead
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Recruitment postcode(s) [11]
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2500 - Wollongong
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Recruitment postcode(s) [12]
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3076 - Epping
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Recruitment postcode(s) [13]
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3084 - Heidelberg
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Recruitment postcode(s) [14]
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3004 - Melbourne
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Recruitment postcode(s) [15]
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3021 - St Albans
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Recruitment outside Australia
Country [1]
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India
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State/province [1]
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Chandigarh
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Country [2]
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India
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State/province [2]
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Delhi
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Country [3]
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India
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State/province [3]
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Manipal
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Country [4]
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India
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State/province [4]
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Nabarangpur
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Country [5]
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India
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State/province [5]
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Pune
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Country [6]
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India
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State/province [6]
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Raipur
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Funding & Sponsors
Primary sponsor type
Other
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Name
The George Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT04394117
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Trial related presentations / publications
Jardine MJ, Kotwal SS, Bassi A, Hockham C, Jones M, Wilcox A, Pollock C, Burrell LM, McGree J, Rathore V, Jenkins CR, Gupta L, Ritchie A, Bangi A, D'Cruz S, McLachlan AJ, Finfer S, Cummins MM, Snelling T, Jha V; CLARITY trial investigators. Angiotensin receptor blockers for the treatment of covid-19: pragmatic, adaptive, multicentre, phase 3, randomised controlled trial. BMJ. 2022 Nov 16;379:e072175. doi: 10.1136/bmj-2022-072175. McGree JM, Hockham C, Kotwal S, Wilcox A, Bassi A, Pollock C, Burrell LM, Snelling T, Jha V, Jardine M, Jones M; CLARITY Trial Steering Committee. Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY): statistical analysis plan for a randomised controlled Bayesian adaptive sample size trial. Trials. 2022 Apr 27;23(1):361. doi: 10.1186/s13063-022-06167-2. Hockham C, Kotwal S, Wilcox A, Bassi A, McGree J, Pollock C, Burrell LM, Bathla N, Kunigari M, Rathore V, John M, Lin E, Jenkins C, Ritchie A, McLachlan A, Snelling T, Jones M, Jha V, Jardine M; CLARITY Investigators. Protocol for the Controlled evaLuation of Angiotensin Receptor blockers for COVID-19 respIraTorY disease (CLARITY): a randomised controlled trial. Trials. 2021 Aug 28;22(1):573. doi: 10.1186/s13063-021-05521-0.
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Public notes
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Contacts
Principal investigator
Name
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Meg Jardine
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Address
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University of Sydney
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences.
Individual participant data that underlie the results reported, after de-identification (text, tables, figures, and appendices), may be shared with Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Supporting document/s available: Study protocol, Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
To be confirmed
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Available to whom?
To be determined
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04394117