NCT04482712撤回1 期
Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of Acute Respiratory Distress Syndrome (RAPA-CARDS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Survival rate
研究概览
简要总结
This study assesses the clinical effectiveness of mammalian target of rapamycin (mTOR) inhibition with rapamycin in minimizing or decreasing the severity of acute lung injury/acute respiratory distress syndrome (ALI/ARDS) in participants infected with mild to moderate COVID-19 virus.
详细描述
This is a single center, double-blind, placebo-controlled, randomized clinical trial in which each participant, after admission to hospital with a diagnosis of mild to moderate COVID-19 infection, will be administered either a dose of rapamycin or the placebo daily. Each subject will receive the assigned treatment until hospital discharge or death. Evaluations will be performed at the beginning of the clinical trial and then daily up to 4 weeks.
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)
盲法说明
This is a double-blind clinical trial
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 60 years of age clinically judged to require hospitalization
- •SARS-CoV2 infection documented by positive RT-PCR nasopharyngeal swab
- •Mild to Moderate clinical status defined as clinical symptoms with or without pneumonia on imaging, with or without fever who are judged to require hospital admission
- •Elevated ferritin
- •Lymphopenia
- •Bilateral opacities on chest x-ray
- •Low pro-calcitonin
- •Clinical signs suggestive of symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea or moderate illness with CoVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute.
排除标准
- •Known or suspected allergy to RAPA
- •High pro-calcitonin
- •SARS-CoV2 documented by negative RT-PCR nasopharyngeal swab
- •Treatment with contraindicated concomitant medications: currently receiving immunosuppressants, including steroids, prior to enrollment, or with immunomodulators or immunosuppressant drugs, including but not limited to Inter leukin (IL)-6 inhibitors, Tumor necrosis factor (TNF) inhibitors, anti-IL-1 agents and Janus kinase (JAK) inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization.
- •Currently receiving immunosuppressants, including steroids, prior to enrollment
- •Serious underlying disease including but not limited to cardiac, pulmonary, renal, hepatic (bilirubin >1.5x Upper normal limit (ULN) or Aspartate Aminotransferase (AST)>ULN but bilirubin ≤ ULN), endocrine (diabetes) or psychiatric disorders judged to be at risk in participating by the inpatient attending physician or team
- •Suspected or confirmed history of alcohol or substance abuse disorder
- •Having participated in other drug trials in the past month
- •Deemed otherwise unsuitable for the study by researchers
- •Clinically judged to not require hospital admission
研究组 & 干预措施
Placebo
Placebo Comparator
Administration of placebo daily during hospitalization
干预措施: Placebo (Drug)
Rapamycin
Active Comparator
Administration of rapamycin (sirolimus) 1mg daily during hospitalization
干预措施: Rapamycin (Drug)
结局指标
主要结局
Survival rate
时间窗: 4 weeks
The proportion of participants who survive without respiratory failure
次要结局
- Change in Clinical Status assessed by the National Institute of Allergy and Infectious Disease (NIAID) scale(Baseline to 4 weeks)
- Change in Clinical Status assessed by the World Health Organization (WHO) scale(Baseline to 4 weeks)
研究者
研究点 (2)
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