Efficacy and safety of Tiprelestat for treatment of severe COVID-19 (COMCOVID trial)
- Conditions
- Adult patients with COVID-19 fulfilling the following criteria:-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.-Hospitalization for COVID-19 treatment.-Without or with oxygen therapy by mask/nasal prong (score 4 or 5 according to WHO COVID-19 clinical progression scale).MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2022-000714-33-DE
- Lead Sponsor
- tiakis Biotech AG (formerly Proteo Biotech AG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 296
1.Signed informed consent and data protection declaration prior to initiation of any trial procedures
2.Patient =18 years of age at time of enrolment and capable of providing informed consent by him-/herself
3.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)
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 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
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 any more]
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 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 contract research organization (CRO), the investigator him- / herself or close relatives of the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of a 7-days treatment with Tiprelestat in patients who have been hospitalized for the treatment of COVID-19;Secondary Objective: To assess the safety of Tiprelestat compared to placebo applied in patients who have been hospitalized for the treatment of COVID-19;Primary end point(s): Rating according to the WHO COVID-19 clinical progression scale on Day 9. ;Timepoint(s) of evaluation of this end point: Day 1 after randomization to Day 29 or Day 1 after randomization to Day of Discharge, if earlier
- Secondary Outcome Measures
Name Time Method