E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 - Oxygen therapy by mask / nasal prong (score 5 according to WHO COVID-19 clinical progression scale)
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E.1.1.1 | Medical condition in easily understood language |
Adult patients with PCR or rapid test confirmed COVID-19 (within last 10 days) hospitalized for COVID-19 with oxygen by mask or nasal prong. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084401 |
E.1.2 | Term | COVID-19 respiratory infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy of a 7-days treatment with Tiprelestat in patients who have been hospitalized for the treatment of COVID-19 |
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E.2.2 | Secondary objectives of the trial |
To assess the safety of Tiprelestat compared to placebo applied in patients who have been hospitalized for the treatment of COVID-19 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. Oxygen therapy by mask / nasal prong (score 5 according to WHO COVID-19 clinical progression scale)
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E.4 | Principal 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. Concomitant respiratory disease requiring supplemental oxygen therapy, apart from COVID-19 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of days with any oxygen support (i.e. WHO COVID-19 clinical progression scale ≥5) |
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E.5.1.1 | 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 |
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E.5.2 | Secondary end point(s) |
- 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 ‘dyspnea’ * - Number of days with ‘fatigue’ * - 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
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Ib: Additional pharmacokinetic whether Tiprelestat accumulates in the first 33 patients |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |