Randomized Open Label Study of Standard of Care Plus an Angiotensin II Receptor Blocker Compared to Standard of Care Alone to Minimize the Progression to Respiratory Failure in SARS-CoV-2 Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 3
- 主要终点
- Mechanical Ventilation
研究概览
简要总结
The purpose of this research is to identify whether or not Angiotensin Receptor Blockers (ARB) can halt the progression to respiratory failure requiring transfer into the intensive care unit (ICU), as well as halt mechanical ventilation in subjects with mild to moderate hypoxia due to the corona virus that causes COVID-19. Based on previous animal studies, the researchers hypothesize that the addition of an ARB is beneficial in abating acute lung injury in subjects in early stages of SARS-CoV-2 viral induced hypoxia.
详细描述
This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding an ARB to the Standard of Care (SOC) to the SOC without an ARB. Randomization ratio will be 1:1. The goal of this study is to identify whether or not ARBs have an impact on inhibiting the progression to respiratory failure requiring mechanical ventilation in patients with mild to moderate hypoxia in the setting of COVID-19. The addition of an ARB to the standard of care treatment for these patients may be beneficial in abating acute lung injury in patients in early stages of SARS-CoV-2 induced hypoxia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Confirmed COVID-19 positive test result
- •Mild to moderate respiratory symptoms of COVID-
- •Systolic blood pressure ≥ 105 mmHg.
- •Screen within 3 days of a positive COVID-19 test.
- •Age ≥18 years old.
- •Access to a phone in the hospital room or an electronic device that is capable of receiving phone or video calls.
- •Able to read/write/speak English or Spanish fluently.
- •Subjects must have the capacity to provide consent or an appropriate LAR to provide informed consent.
- •Negative pregnancy test for women of childbearing potential and subject is randomized to the study arm.
排除标准
- •Severe allergy to any ARB or ACE-inhibitor, including angioedema
- •In the intensive care unit at screening.
- •Home meds include any kind of ACE inhibitor or ARB
- •Acute Kidney Injury (50% reduction in GFR from baseline at admission to any time during treatment in the study treatment arm)
- •Hyperkalemia >5.0 mmol/L at baseline or any time during treatment in the study treatment arm
- •Creatinine Clearance < 30 ml/min at baseline or any time during treatment in the study treatment arm
研究组 & 干预措施
Group A (Study drug+SOC)
Standard of Care plus an ARB to be taken orally twice daily for up to 10 days or until discharged from the hospital, whichever occurs first. Investigator may increase dose on days 2 - 10 if confident the subject will tolerate.
干预措施: Losartan (Drug)
结局指标
主要结局
Mechanical Ventilation
时间窗: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Number of subjects requiring transfer into ICU for mechanical ventilation due to respiratory failure
次要结局
- ICU Transfer(from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days)
- Oxygen Therapy(from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days)
研究者
Matthew Geriak
Investigational Pharmacist
Sharp HealthCare