Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 787
- 试验地点
- 22
- 主要终点
- 7-Point National Institute of Health Clinical Health Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Trial Statistician and sponsor staff will remain blinded to treatment allocation throughout the trial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Potential participants must satisfy all of the following:
- •Laboratory-confirmed* diagnosis of Severe Acute Respiratory Syndrome-Coronavirus-2 infection within 10 days prior to randomisation
- •Age ≥ 18 years
- •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
- •Participant and treating clinician are willing and able to perform trial procedures.
- •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:
- •Age≥60 years
- •Body Mass Index ≥30kg/m2 (derived from the patient's self-report of their height and weight where these are not measured directly)
- •Diagnosis of diabetes defined as HbA1c ≥7% and/or the consumption of glucose lowering medication
- •History of cardiovascular disease
- •History of chronic respiratory illness
- •Currently treated with immunosuppression
排除标准
- •Currently treated with an angiotensin-converting enzyme inhibitor, Angiotensin Receptor Blocker or aldosterone antagonist, aliskiren, or angiotensin receptor-neprilysin inhibitors (ARNi)
- •Serum potassium > 5.2 mmol/L or no potassium testing within the last 3 months
- •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
- •Known symptomatic postural hypotension
- •Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15) - see Table below
- •Intolerance of ARB
- •Pregnancy or risk of pregnancy, defined as;
- •(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
- •(In India Only) Women who are pregnant
- •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
研究组 & 干预措施
Standard Care + Angiotensin Receptor Blocker (ARB)
Participants will receive an Angiotensin Receptor Blocker on top of the standard care provided by their institution.
干预措施: Angiotensin Receptor Blockers (Drug)
Standard Care + Placebo
Participants will receive a placebo on top of the standard care provided by their institution.
干预措施: Placebo (Other)
结局指标
主要结局
7-Point National Institute of Health Clinical Health Score
时间窗: 14 Days
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;
次要结局
- Dialysis Requirement(28 Days)
- Ventilator-Free Days(28 Days)
- Mortality(90 Days)
- Acute Kidney Injury(28 Days)
- Dialysis Days(28 Days)
- Hypotension Requiring Vasopressors(28 Days)
- Hospitalisation Days(90 Days)
- 7-Point National Institute of Health Clinical Health Score(28 Days)
- Intensive Care Unit Admission(90 Days)
- Respiratory Failure(28 Days)
- Intensive Care Unit Number of Days(90 Days)