A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety and Efficacy of Angiotensin (1-7) for the Treatment of COVID-19 in Hospitalized Patients
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to recovery
研究概览
简要总结
The primary objective is to evaluate the safety and efficacy of intravenous (IV) infusion of Ang (1-7) compared to placebo with respect to time to recovery, disease severity, need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO), and mortality in patients with COVID 19.
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
- Double (Participant, 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
- •Signs and symptoms suggestive of COVID-19 infection including cough or dyspnea
- •Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) test ≤7 days before randomization
- •Currently hospitalized or in an emergency department with planned hospitalization
- •Peripheral capillary oxygen saturation (SpO2) ≤93% on room air or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) <300 at Screening
排除标准
- •Simultaneous participation in any other clinical study incompatible with this one
- •Treatment with an antibody immunotherapy that is not standard of care for COVID-19 within 4 weeks of Screening
- •Requirement for mechanical ventilation or ECMO at Screening
- •Hypotension at Screening, defined as supine BP <95 mm Hg systolic or <55 mm Hg diastolic
- •Severe liver injury defined as AST or ALT ≥5x the upper limit of normal
- •Severe kidney failure defined as an estimated glomerular filtration rate (eGFR) <30 mL/min
- •Any known immune deficiency
- •Pregnancy or breastfeeding
研究组 & 干预措施
Angiotensin (1-7)
Participants receive treatment for 7 days.
干预措施: Angiotensin-(1-7) (Drug)
Placebo
Participants receive treatment for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to recovery
时间窗: Up to 29 days
Time to recovery, defined as attaining a score of 6, 7, or 8 on the COVID-19 disease severity scale, an 8 point ordinal scale used in the NIH Adaptive COVID-19 Treatment Trial (ACTT; NCT04280705). 1. = Death; 2. = Hospitalized and on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. = Hospitalized and on non-invasive ventilation or high-flow oxygen devices; 4. = Hospitalized and requiring supplemental oxygen; 5. = Hospitalized and not requiring supplemental oxygen but requiring ongoing medical care (COVID-19-related or otherwise); 6. = Hospitalized and not requiring supplemental oxygen and no longer requiring ongoing medical care; 7. = Not hospitalized, limitation on activities and/or requiring home oxygen; 8. = Not hospitalized, no limitation on activities
次要结局
- Incidence of mortality at Day 29(29 days)
- Number of participants requiring mechanical ventilation or ECMO, or dying, through Day 29(Up to 29 days)
- COVID-19 disease severity scale score on Day 8(Day 8)
- COVID-19 disease severity scale score on Day 15(Day 15)
- COVID-19 disease severity scale score on Day 29(Day 29)
- Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose(Up to 29 days)
- COVID-19 disease severity scale score on Day 22(Day 22)