EUCTR2022-000715-31-ES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 ID0 个研究点目标入组 800 人开始时间: 2022年6月10日最近更新:
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
- •Fostamatinib Arm-Specific Exclusion Criteria:
- •1. Randomized in another trial evaluating fostamatinib in the prior 30 days
- •Fostamatinib Arm-Specific Exclusion Criteria measured within 24-hours prior to randomisation:
- •1. AST or ALT = 5 × upper limit of normal (ULN) or ALT or AST = 3 × ULN and total bilirubin = 2 × ULN
- •2. SBP > 160 mmHg or DBP > 100 mmHg at the time of screening and randomization
- •3. ANC < 1000/mL
- •4. Patient requires use of strong CYP3A modulators from Table above (Clarithromycin, Indinavir, Itraconazole, Ketoconazole, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Telithromycin, Troleandomycin, Carbamazepine, Efavirenz, Enzalutamide, Modafinil, Nevirapine, Oxcarbazepine, Phenobarbital, Phenytoin, Rifabutin, Rifampin, St. John’s Wort, or Troglitazone).
- •5. Patient unable to participate or declines participation in the fostamatinib arm.
研究者
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