EUCTR2020-001739-28-BE进行中（未招募）1 期
A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19. - DAWN AntiCo
ZLeuven0 个研究点目标入组 210 人开始时间: 2020年4月10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
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject (=18 years old) or legally authorized representative provides informed consent prior to initiation of any study procedures. When signed informed consent is not possible (e.g. due to restrictions to prevent viral transmission), verbal informed consent in the presence of a witness will be obtained and documented in the medical files. Signed informed consent will be obtained as soon as the safety concerns are mitigated.
- •2. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
- •3. Male or non-pregnant female adult =18 years of age at time of enrolment.
- •4. Has a confirmed diagnosis of SARS-CoV-2 infection, defined as either:
- •a. laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen as diagnosed within 72 hours prior to randomization
- •b. The combination of upper or lower respiratory infection symptoms (fever, cough, dyspnea, desaturation) and typical findings on chest CT scan and absence of other plausible diagnoses
- •5. Illness of any duration, and at least one of the following:
- •a. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or
- •b. Clinical assessment (evidence of rales/crackles on lung auscultation) AND SpO2 = 94% on room air, or
- •c. Requiring mechanical ventilation and/or supplemental oxygen.
- •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 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •1. ALT/AST > 8 times the upper limit of normal.
- •2. Pregnancy or breastfeeding.
- •3. Allergy to any study medication.
- •4. Any medical condition which would impose an unacceptable safety hazard by participation in the study.
- •5. Study drug-specific exclusion criteria:
- •For Aprotinin:
- •o Known active thromboembolic disease, defined as a history of idiopathic (unprovoked) deep vein thrombosis or pulmonary embolism, recent (<3m) deep vein thrombosis or pulmonary embolism, recent (<6m) myocardial infarction or coronary stenting, recent (<6m) ischemic stroke
- •o Renal insufficiency with CrCl <30ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis
- •o Recent (<6m) cardiac surgery with cardiopulmonary bypass and/or use of aprotinin
- •For LMWH:
- •o Active bleeding, a history of intracranial bleeding, or a recent (<3m) GI bleeding requiring transfusion and/or intervention, recent surgery in the central nervous system
- •o Renal insufficiency with CrCl < 20ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis
- •o Blood platelet count < 30 000/µL
- •o Other conditions that are judged to carry an increased risk of bleeding as judged by the investigator
- •o Need for therapeutic anticoagulation (known active thrombo-embolic diseases, atrial fibrillation, mechanical prosthetic heart valve,…)
- •For Anakinra:
- •o Impairment of cardiac function defined as severe heart failure, unstable angina pectoris, myocardial infarction within 6 months before enrollment, ventricular arrhythmia requiring treatment or intervention.
- •o Severe renal dysfunction (creatinine clearance = 20mL/min) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
- •o Uncontrolled hypertension (persistent systolic blood pressure >180mmHg, or diastolic blood pressure >110mmHg)
- •o Clinical suspicion of latent tuberculosis
- •o Clinical suspicion of severe bacterial surinfection (e.g. ventilator-associated pneumonia)
研究者
相似试验
暂停
3 期
An Open-Label Randomized Controlled, Proof-of-Concept (PoC) Study toEvaluate the Safety and Efficacy of selected Siddha formulations in patientsdiagnosed with COVID-19CTRI/2020/06/025762ational Institute of Siddha
已完成
不适用
An open-label, randomized, single center, adaptive, parallel group study to investigate the single dose oral pharmacokinetics (PK) properties of olesoxime formulated as an oral suspension and as an oral solution in the fed stateNeurological muscle degenerationSpinal muscular atrophy10029317NL-OMON45676Hoffmann-La Roche90
进行中（未招募）
1 期
An open-label, adaptive randomized, controlled multicenter study to evaluate the efficacy and safety of RESP301+SOC vs SOC in hospitalized participants with COVID-19 requiring supplemental oxygeCoronavirus disease 2019 (COVID-19)MedDRA version: 20.0Level: LLTClassification code 10061986Term: SARSSystem Organ Class: 100000004862EUCTR2020-002120-37-GBThirty Respiratory Limited300
已完成
2 期
A study to assess the efficacy and safety of Fixed Dose Combination of Capecitabine & Cyclophosphamide in patients of Metastatic Breast CancerCTRI/2014/12/005234Intas Pharmaceuticals Ltd166
进行中（未招募）
1 期
Treatment for Metastatic Adenocarcinoma of the PancreasEUCTR2018-000377-68-HUSynCore Biotechnology Co., Ltd.218