E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
SARS-coronavirus-2 infection |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 compare the treatment effect of aerosolized DNase I (Pulmozyme) to that of placebo (NaCl, 0.9%) on time to cessation of oxygen therapy or discharge from hospital in hospitalized patients with COVID-19 and respiratory dysfunction. |
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E.2.2 | Secondary objectives of the trial |
To compare the treatment effect of aerosolized DNase I (Pulmozyme) to that of placebo (NaCl, 0,9%) on 28-day mortality, days alive and without ventilator treatment, days alive and without high flow nasal oxygen treatment (Optiflow), days alive and free of stay in the Intensive care unit (ICU), days alive and outside hospital, days alive and free of new of episode with saturation ≤93% after the primary endpoint has been met, days alive and without need for supplemental oxygen, adverse reactions.
Exploratory objectives: quantification of NETs in respiratory secretions and on the incidence of clinical thromboembolic events. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Age ≥18 years old. 2.Admitted to hospital ward or ICU. 3.A positive PCR test for SARS-CoV-2 from throat swab or nasopharynx. 4.An oxygen saturation ≤90% after maximum 15 minutes without supplemental oxygen. 5.Signed informed consent. |
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E.4 | Principal exclusion criteria |
1.Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation. 2.Known or suspected allergy against Pulmozyme (dornase alfa). 3.Chronic obstructive pulmonary disease stage III-IV or another comparable chronic respiratory disease. 4.Participation in a clinical study with an investigational product during the last 30 days. 5.Previous participation in this study. 6.Pregnancy. Women of childbearing potential must agree to use contraceptives for the duration of the study period. 7.Any condition that, in the opinion of the Investigator, would place the patient at increased risk or preclude the patient’s compliance with the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Time (days) until the study patient has an oxygen saturation of >93% without supplemental oxygen for 24 hours or until the patient is discharged from the hospital. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary endpoint(s) (variables): 28-day mortality; days alive and without ventilator treatment; days alive and without high flow nasal oxygen treatment(Optiflow); days alive and free of stay in the ICU; days alive and outside hospital; days alive and free of new episode with saturation ≤93% after the primary endpoint has been met; days alive and without need for supplemental oxygen; adverse reactions.
Exploratory enpoint(s) (variables): Quantification of NETs in samples from the respiratory tract and number of clinical thromboembolic events.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | 2 |
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 | 1 |
E.8.9.1 | In the Member State concerned days | 0 |