EUCTR2022-000715-31-IT进行中（未招募）1 期
Clinical Trials targeting macro-, micro-immuno-thrombosis, vascular hyperinflammation, and hypercoagulability and renin-angiotensin-aldosterone system (RAAS) in hospitalized patients with COVID-19 (ACTIV-4 Host Tissue) - NECTAR
EAT ID Foundation0 个研究点目标入组 800 人开始时间: 2022年9月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Hospitalized for COVID-19
- •2. =18 years of age
- •3. SARS-CoV-2 infection, documented by:
- •a. a nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR
- •b. documented by NAT or equivalent testing more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests is maintained in Appendix G.)
- •4. Hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 =92%, or increased supplemental oxygen to maintain SpO2 =92% for a patient on chronic oxygen therapy
- •5. Symptoms or signs of acute COVID-19, defined as one or more of the following:
- •b. Reported or documented body temperature of 100.4o F or greater
- •c. shortness of breath
- •d. chest pain
- •e. infiltrates on chest imaging (x-ray, CT scan, lung ultrasound)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1. COVID-19 symptom onset >14 days prior to randomization
- •2. Hospitalized for >72 hours prior to randomization
- •3. Pregnancy
- •4. Breastfeeding
- •5. Prisoners
- •6. End-stage renal disease (ESRD) on dialysis
- •7. Patient and/or clinical team is not pursuing full medical management (if a patient has a Do Not Resuscitate order that precludes chest compressions in the event of a cardiac arrest but is otherwise pursuing full medical management, he/she is eligible for this trial).
- •8. The treating clinician expects inability to participate in study procedures or participation would not be in the best interests of the patient
- •See agent-specific appendices in the full protocol for agent-specific exclusion criteria
研究者
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