EUCTR2021-002200-12-NL进行中（未招募）1 期
A multiple dosing study to demonstrate the safety, tolerability, pharmacokinetics and efficacy potential ofintravenously administered ANXV (a recombinant human Annexin A5) in patients with confirmed moderate tosevere COVID-19; The CO-ANNEXIN Study. - The CO-ANNEXIN Study
MUMC AZm0 个研究点目标入组 12 人开始时间: 2021年12月17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
- 12
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
- •Patients must be at least 18 years of age or older, with clinically evident or otherwise confirmed moderate to severe COVID-19
- •pneumonia, with PCR-confirmed presence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
- •They have to be in need for oxygen supply, via high flow nasal oxygen (optiflow).
- •Inclusion criteria
- •1. Patients hospitalized for laboratory documented SARS-CoV2 infection (qRT-PCR).
- •2. Males between 18 and 75 years or Females of non-reproductive age or capacity, i.e post-menopausal or sterile, and between 18
- •and 75 years.
- •3. Signed informed consent by patient
- •4. Hospitalized with a resting oxygen saturation on room air of <92 %, AND receiving high flow nasal oxygen.
- •5. Elevated LDH (>350U/L, n=97-247 U/l)
- •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 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject requiring mechanical ventilation/ extracorporeal membrane oxygenation and in-tubated for mechanical ventilation.
- •2. Severe COPD, defined by continuous use of long-acting bronchodilators or inhaled/oral corticosteroids for > 2 months in the
- •home situation.
- •3. Subject with severe renal impairment (eGFR < 30 ml/min)
- •4. Subjects on chronic dialysis.
- •5. Subject with an active malignancy within the last three months, and/or a risk of mortality >50% within 6 months.
- •6. Bleeding Risk:
- •a. Clinical: Active bleeding; head trauma, intracranial surgery or stroke within 3 months; history of intracerebral arteriovenous
- •malformation, cerebral aneurysm or mass lesions of the central nervous system; cerebral haemorrhage; history of a bleeding
- •diatheses; gastrointestinal bleeding within 6 weeks; presence of an epidural or spinal catheter; contraindication for IV therapeutic
- •b. Laboratory: Platelet count <50 x109/L, INR >3.0 or baseline aPTT =45 seconds prior to enrolment.
- •7. Use of any of the following treatments: UFH to treat a thrombotic event within 12 hours before enrolment; thrombolytic therapy
- •within 3 previous days;
- •8. Confirmed antiphospholipid syndrome, systemic lupus erythematosus and other auto-immune diseases (at discretion of PI)
- •9. Confirmed thalassemias (e.g sickle cell disease)
- •10. Cardiopulmonary resuscitation in previous 7 days.
- •11. Liver failure defined as Child-Pugh Score Class C.
- •12. Abnormal liver function (AST >5xULN, ALT >5xULN)
- •13. Life expectancy of <24 hours
- •14. Treating physician refusal.
- •15. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol.
- •16. Participation in any other investigational drug study
研究者
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