NCT04555096终止2 期
A Pilot, Randomized, Placebo-Controlled Trial of GC4419 (Avasopasem Manganese) in Patients With Critical Illness Due to SARS-CoV-2 Infection (COVID-19)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- 28 Day All-cause Mortality
研究概览
简要总结
A Trial of GC4419 in Patients with Critical Illness due to 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female subjects at least 18 years of age.
- •Ability to understand and the willingness to sign a written informed consent.
- •Laboratory-confirmed SARS-CoV-2 infection as determined by a positive PCR test documented prior to randomization
- •Requirement for intensive inpatient hospital care
- •Acute hypoxemic respiratory failure typifying ARDS
- •Adequate liver function
- •Use of effective contraception
排除标准
- •Expected survival for less than 48 hours after randomization
- •Child-Pugh stage C hepatic impairment and/or portal hypertension secondary to cirrhosis
- •Stage IV chronic kidney disease or end-stage kidney disease on maintenance hemodialysis
- •Requirement for extra-corporeal membrane oxygenation (ECMO)
- •Acute Myocardial Infarction (AMI)
- •Active bleeding requiring transfusion
- •Concurrent participation in another clinical trial of experimental treatment for SARSCoV-2
- •Female patients who are pregnant or breastfeeding
- •Requirement for concurrent treatment with nitrates
研究组 & 干预措施
Active GC4419
Experimental
Arm A
干预措施: GC4419 (Drug)
Placebo
Placebo Comparator
Arm B
干预措施: Placebo (Drug)
结局指标
主要结局
28 Day All-cause Mortality
时间窗: 28 days
Death rate of patients with critical illness due to COVID-19 28 days after initiation of therapy.
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
相似试验
Unknown
2 期
Safety and Efficacy of Therapeutic Anticoagulation on Clinical Outcomes in Hospitalized Patients With COVID-19Cardiovascular DiseasesCOVID-19NCT04377997Massachusetts General Hospital300
尚未招募
不适用
Ozone Therapy for Covid 19 patientsCTRI/2020/07/026671Bisleri charitable trust
已完成
2 期
Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)COVID-19NCT04655625AnGes, Inc.500
撤回
2 期
Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium NitriteCOVID-19Acute Respiratory Distress SyndromeAcute Respiratory FailureNCT04401527Hope Pharmaceuticals
已完成
3 期
Efficacy of Chloroquine or Hydroxychloroquine in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19COVIDCOVID-19SARS-CoV 2CoronavirusCorona Virus InfectionNCT04420247Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva142