{"id":544,"date":"2020-04-28T15:09:49","date_gmt":"2020-04-28T05:09:49","guid":{"rendered":"https:\/\/www.tracktrial.org\/?page_id=544"},"modified":"2021-01-22T10:58:02","modified_gmt":"2021-01-21T23:58:02","slug":"trial-synopsis","status":"publish","type":"page","link":"https:\/\/www.claritytrial.org\/?page_id=544","title":{"rendered":"Trial Synopsis"},"content":{"rendered":"\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Title<\/h3>

Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease<\/p>

Short title<\/h3>

CLARITY<\/p>

Trial Registration<\/h3>

ClinicalTrials.gov Identifier: NCT04394117<\/a>
Clinical Trials Registry \u2013 India (CTRI) Number: CTRI\/2020\/07\/026831<\/a><\/p>

Design<\/h3>

Prospective, double-blind, placebo-controlled, randomised controlled trial in India.
Prospective, open-label, randomised controlled trial in Australia.<\/p>

Intervention<\/h3>

Standard Care + Angiotensin Receptor Blocker (ARB), or Standard Care + matched placebo in India
Standard Care + ARB, or Standard Care alone in Australia.<\/p>

Primary Outcome Measure<\/h3>

To establish evidence on the effect of ARB treatment on a 7-point ordinal score of clinical outcomes in respiratory disease, in patients recently diagnosed with SARS-CoV-2.<\/p>

Inclusion criteria<\/h3>

Potential participants must satisfy all of the following:<\/p>

  1. Laboratory-confirmed diagnosis of SARS-CoV-2 infection within 10 days prior to randomisation<\/li>
  2. Age \u2265 18 years<\/li>
  3. a) Systolic Blood Pressure (SBP) \u2265 120 mmHg<\/li>
  4. b) SBP \u2265 115 mmHg and currently treated with a non-RAASi Blood Pressure (BP) lowering agent that can be ceased<\/li>
  5. Participant and treating clinician are willing and able to perform trial procedures.<\/li>
  6. Either<\/em> Intended for hospital admission for management of COVID-19, or <\/em>(In Australia Only) Intended for management at home with one or more of the following criteria:<\/li><\/ol>
      1. Age \u2265 60 years<\/li>
      2. BMI \u226530kg\/m2<\/sup> (derived from the patient\u2019s self -report of their height and weight where these are not measured directly)<\/li>
      3. Diagnosis of diabetes defined as HbA1c \u22657% and<\/em>\/or<\/em> the consumption of glucose-lowering medication<\/li>
      4. History of cardiovascular disease<\/li>
      5. History of chronic respiratory illness<\/li>
      6. Currently treated with immunosuppression<\/li><\/ol><\/li><\/ol>

        Exclusion criteria<\/h3>
        1. Currently treated with Angiotensin-Converting Enzyme Inhibitor (ACEi), ARB or aldosterone antagonist, aliskiren, or angiotensin receptor-neprilysin inhibitors (ARNi)<\/li>
        2. Serum potassium > 5.2 mmol\/L or no potassium testing within the last 3 months<\/li>
        3. For those intended for hospital admission, an estimated Glomerular Filtration Rate (eGFR) <30ml\/min\/1.73m2<\/sup> or no eGFR testing within the last 3 months, or <\/em>For those intended for management at home (Australia only), an eGFR <45ml\/min\/1.73m2<\/sup> or no eGFR testing within the last 3 months<\/li><\/ol>
          1. Known symptomatic postural hypotension<\/li>
          2. Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15)<\/li>
          3. Intolerance of ARB<\/li>
          4. 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<\/li>
            2. (In India Only) Women who are pregnant<\/li><\/ol><\/li>
            3. Women who are currently breastfeeding<\/li>
            4. 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<\/li><\/ol>

              Primary Outcome Measure<\/h3>

              The primary endpoint is a 7-point ordinal categorical scale of the clinical status of the participant, assessed on Day 14 post-randomisation. The worse result of the day will be recorded. The scale is described as;<\/p>

              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.<\/p>

              Secondary Outcomes<\/h3>

              1. Intensive Care Unit (ICU) admission and length of stay
              2. Death
              3. Rates and length of Hospitalisation
              4. Ventilator requirement
              5. Dialysis requirement
              6. Incidence of Acute Kidney Injury (AKI)
              7. Respiratory Failure
              8. Incidence of Hypotension
              9. Incidence of Hyperkalaemia<\/p>

              Randomisation<\/h3>

              Participants will be randomised in a 1:1 ratio. Randomisation will be stratified by country and in Australia, whether the participant is planned for hospital admission or home-based care.<\/p>

              Sample Size<\/h3>

              Trial will adopt a Bayesian adaptive approach to sample size calculations. The trial will continue to recruit until predefined superiority or futility rules are met.
              Minimum sample size = 700, Maximum Sample size = 2200<\/p>

              Funding<\/h3>

              Medical Research Future Fund, Australia<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

              \n\t\t\t\t\t\t
              \n\t\t\t\t\t
              \n\t\t\t
              \n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

              Title Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease Short title CLARITY Trial Registration ClinicalTrials.gov Identifier: NCT04394117 Clinical Trials Registry \u2013 India (CTRI) […]<\/a><\/p>\n<\/div>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-full.php","meta":{"footnotes":""},"class_list":["post-544","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.claritytrial.org\/index.php?rest_route=\/wp\/v2\/pages\/544","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.claritytrial.org\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.claritytrial.org\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.claritytrial.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.claritytrial.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=544"}],"version-history":[{"count":42,"href":"https:\/\/www.claritytrial.org\/index.php?rest_route=\/wp\/v2\/pages\/544\/revisions"}],"predecessor-version":[{"id":1765,"href":"https:\/\/www.claritytrial.org\/index.php?rest_route=\/wp\/v2\/pages\/544\/revisions\/1765"}],"wp:attachment":[{"href":"https:\/\/www.claritytrial.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=544"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}