RECOVER: Phase 2 Randomized, Double-Blind Trial TREating Hospitalized Patients With COVID-19 With Camostat MesilatE, a TMPRSS2 Inhibitor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of Patients Alive and Free From Respiratory Failure
研究概览
简要总结
To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
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
- •Laboratory confirmed SARS-CoV-2 infection
- •Admitted to hospital for management of SARS-CoV-2
- •Subject or legal representative able to give informed consent
- •Ability to take all study drugs
- •Respiratory status of 3 or greater on the WHO ordinal scale
- •ALT or AST ≤5 x ULN
- •Creatinine clearance ≥50 mL/min using the Cockroft-Gault formula
- •Willingness to provide mandatory specimens for correlative research and banking
排除标准
- •Women who are pregnant or breastfeeding
- •Known hypersensitivity to the study drug, the metabolites or formulation excipient
研究组 & 干预措施
Placebo + Standard of Care
Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.
干预措施: Standard of Care (Other)
Camostat + Standard of Care
Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
干预措施: Camostat Mesilate (Drug)
结局指标
主要结局
Proportion of Patients Alive and Free From Respiratory Failure
时间窗: 28 Days
To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will change the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
次要结局
- Proportion of Patients Alive and Free of Ventilator Use or ECMO(28 Days)
- Mortality Rate(28 Days)
- Clinical Change(28 Days)
- Adverse Event Grade 3 Plus Rate(28 days)
研究者
Alan Bryce
Principal Investigator
Academic and Community Cancer Research United