DRKS00031463进行中（未招募）2 期
Efficacy and safety of Tiprelestat for treatment of severe COVID-19 (COMCOVID trial) - COMCOVID
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Patient with COVID-19 fulfilling the following criteria:
- •a. First laboratory-confirmation of the current episode of SARS-CoV-2 infection (COVID-19) as determined by PCR or antigen test (no self-tests) in any defined specimen collected within 10 days prior to trial enrolment.
- •b. Hospitalization for COVID-19 treatment
- •c. without or with oxygen therapy by mask / nasal prong (score 4 or 5 according to WHO COVID-19 clinical progression scale)
排除标准
- •1. Life time expectancy of 2 days or less as judged by the investigator
- •2. Malignant disease requiring chemotherapy, radiation therapy and / or immune therapy at the time of enrolment
- •3. Patient requiring dialysis
- •4. [not applicable anymore]
- •5. Only for female patients of childbearing potential: Pregnancy, positive pregnancy test on Day 1, breast feeding or no effective contraception
- •6. Current or previous participation within the past 30 days in another interventional clinical trial with an investigational medicinal product
- •7. Known to be or suspected of being unable to comply with the clinical trial protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
- •8. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial
- •9. Patient in custody by juridical or official order evidence of an uncooperative attitude
- •10. Patient, who is a member of the staff of the trial center, staff of the sponsor or CRO, the investigator him- / herself or close relatives of the investigator
研究者
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