A Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Efficacy of Ramipril to Prevent ICU Admission, Need for Mechanical Ventilation or Death in Persons With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Composite of Mortality or Need for ICU Admission or Ventilator Use
研究概览
简要总结
In this study we propose to treat 560 patients with ramipril or placebo for 14 days. After an initial evaluation for COVID-19 status, medical history, and symptom assessment, patients will receive either 2.5 mg/day of ramipril or placebo. Patients' symptoms and study endpoints will be monitored at regular intervals. After 14 days, patients will undergo a laboratory assessment and an end-of-treatment follow-up visit at day 28. The primary endpoints of successful therapy will be improved survival, reductions in ICU admissions, and/or reductions in use of mechanical ventilator support.
详细描述
Ramipril has not been studied in SARS-CoV-2 infected patients. In this study we propose to treat 560 patients with ramipril or placebo for 14 days. After an initial evaluation for COVID-19 status, medical history, and symptom assessment, patients will receive either 2.5 mg/day of ramipril or placebo. Patients' symptoms and study endpoints will be monitored at regular intervals. Additional follow-up will be performed at day 28. As an exploratory objective, biomarkers of the RAAS axis will also be monitored. The primary endpoints of successful therapy will be improved survival, reductions in ICU admissions, and/or reductions in use of mechanical ventilator support. Secondary endpoints will be the proportion of patients needing continued hospitalization, time to mortality, time to ICU admission, time to discharge from hospital, proportion of patients developing hypotension and needing pressor support, and proportion of patients developing septic shock.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age ≥ 18 years
- •Willing and able to provide written informed consent prior to performing study procedures
- •Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 5 days before randomization OR Clinical presentation consistent with COVID-19 infection (fever or cough or shortness of breath) with positive IgM serology
- •Currently hospitalized or in an emergency department
- •Peripheral capillary oxygen saturation (SpO2) ≥ 93% on room air at screening
排除标准
- •Participation in any other clinical trial of an experimental treatment for COVID-19 (use of hydroxycholoroquine or compassionate use of choloroquine or azithromycin is allowed)
- •Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug/placebo dosing
- •Requiring mechanical ventilation at screening
- •Requiring ICU care at admission
- •NSAID use within 12 hours of randomization or requiring continued NSAID use during this trial
- •Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
- •Estimated GFR < 40 mL/min
- •History of serum creatinine ≥ 2 mg/dl in the previous 28 days
- •Systolic BP < 100 mm hg or diastolic BP < 65 mm hg
- •Hypersensitivity to ACEI
- •History of angioedema
- •Outpatient use of ACE inhibitor or Angiotensin II receptor blocker in the last 7 days
- •History of renal artery stenosis
- •Serum potassium ≥ 5.1 mEq/L
- •Pregnancy or breastfeeding
- •Use of aliskiren, amifostine, lithium, sacubitril within 7 days
研究组 & 干预措施
Ramipril 2.5mg orally daily
Total 2.5 mg Ramipril per day once a day orally for 14 days
Intervention: Ramipril
干预措施: Ramipril 2.5 MG Oral Capsule (Drug)
Placebo
Placebo in the form of a capsule, taken orally for 14 days
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Composite of Mortality or Need for ICU Admission or Ventilator Use
时间窗: 14 days
The major primary outcome to be evaluated is improving a composite outcome of mortality or need for ICU admission or ventilator use within a 14-day window.
次要结局
未报告次要终点
研究者
Rohit Loomba
Professor of Medicine
University of California, San Diego