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: 23.1 Level: LLT Classification code 1008
Conditions
Interventions
Product Name: Tiprelestat
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Tiprelestat
CAS Number: 820211-82-3
Other descriptive name: Elafin
Concentration unit: mg/ml m
Sponsors
tiakis Biotech AG (formerly Proteo Biotech AG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Rating according to the WHO COVID-19 clinical progression scale on Day 8 - Rating according to the WHO COVID-19 clinical progression scale on Day 10 - Rating according to the WHO COVID-19 clinical progression scale on Day 14F - Proportion [n/N] of patients discharged from hospital on Day 9 - Number of days with any oxygen support (i.e. WHO COVID-19 clinical progression scale =5) * - Proportion of patients [n/N] with progression to severe disease according to the WHO COVID-19 clinical progression scale (score =6) (time frame: Day 1 after randomization to Day 29 or Day 1 after randomization to Day of Discharge, if earlier) - Time to first occurrence of severe disease (score =6) according to the WHO COVID-19 clinical progression scale * - Number of days of severe disease (score =6) according to the WHO COVID-19 clinical progression scale * - Number of days in ICU * - Number of days with ‘ resting dyspnea’ ** - Number of days with ‘fatigue’ ** - Number of days with 'exertional dyspnea' ** - 28-day mortality [n/N] - 90-day mortality [n/N] * Time frame: Day 1 after randomization to Day 29 or Day 1 after randomization to Day of Discharge, if earlier ** Time frame: Day 1 after randomization to Day 29;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 | — |
Countries
Germany
Contacts
Public ContactPreclinical a. Clinical Development
tiakis Biotech AG (formerly Proteo Biotech AG)
Outcome results
None listed