Randomized Controlled Trial of Angiotensin 1-7 (TXA127) for the Treatment of Severe COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change of Serum Creatinine
研究概览
简要总结
The purpose of this study is to determine if administration of angiotensin-(1-7) (TXA127) prevents acute kidney injury and deterioration into multi-organ failure in patients with severe COVID-19. Participants will undergo a 10-day treatment with either placebo or study drug. The drug will be administered intravenously for 3 hours once each day for 10 days consecutively.
详细描述
Corona virus disease 2019 (COVID-19) has been associated with severe respiratory and multiorgan failure. Research shows that COVID-19 reduces levels of angiotensin-converting enzyme-2 (ACE-2), an enzyme that converts angiotensin II to angiotensin 1-7 (known as TXA127). COVID-19 reduces levels of ACE-2 and therefore angiotensin 1-7 and as a result, angiotensin II levels are going to be increased. Many clinical observations in COVID-19 have shown the high incidence of acute kidney injury that may be due to excessive levels of angiotensin II. The investigators hypothesize that administration of angiotensin (1-7) replaces levels of ACE-2 in COVID-19 and thereby ameliorates deterioration of multi-organ failure and specifically acute kidney injury.
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
- •Severe COVID-19: Adult patients admitted to the hospital through the Emergency Department (ED) requiring oxygen therapy (any level) to maintain oxygen saturation (SaO2) > 90%
- •COVID positive by polymerase chain reaction (PCR) on hospital admission
- •Hospitalized patients aged 18 years or greater
排除标准
- •Pre-existing chronic kidney disease
- •New use of or change in dose of ACE-inhibitors or angiotensin receptor blocker (ARB) within the last 6 months
- •Acute kidney injury at the time of enrollment defined as either increase pf serum creatinine by more than 50% or 0.3 mg/dL above baseline or estimated creatinine clearance (by MDRD) of less than 60 ml/min (if no baseline serum creatinine available)
- •Pregnant and breastfeeding women
- •Contraindicated medications: new use or change of medications from start of trial (start of an ACE inhibitor or ARB within 6 months of trial).
研究组 & 干预措施
TXA127
Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days).
干预措施: TXA127 (Drug)
Placebo
Participants will receive one 3-hour dosage (0.5 mg/kg per day), intravenously, for 10 days consecutively (or until discharge if less than 10 days).
干预措施: Placebo (Drug)
结局指标
主要结局
Change of Serum Creatinine
时间窗: Day 1 and Day 10
Calculated from baseline (at enrollment) to end of study
Number of Participants Requiring Intubation
时间窗: From Day 1 to Day 10
次要结局
- Percent Change in Supplemental Oxygen Requirements(Day 1 and Day 10)
- Days of Hospital Stay and Drug Administration(Day 1 to Day 10)
- Cytokine Levels on the Day 5 of Drug/TXA Administration(Day 5)
- Number of Participants Requiring Dialysis(Up to Day 10)
- Number of Participants Requiring a Vasopressors(Up to Day 10)
- Mortality(Day 1 to Day 10)
- Cytokine Levels on the Day of Drug/TXA Administration(Day 1)
研究者
Jeanine D'Armiento
Associate Professor of Medicine (in Anesthesiology)
Columbia University