Efficacy and safety of Tiprelestat for treatment of severe COVID-19 (COMCOVID trial)
- Conditions
- COVID-19 hospitalized for COVID-19 treatment with score 4 or 5 according to WHO COVID-19 clinical progression scale
- Registration Number
- DRKS00031463
- Lead Sponsor
- tiakis Biotech AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 17
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)
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method WHO COVID-19 clinical progression scale at Day 9
- Secondary Outcome Measures
Name Time Method