SARS-coronavirus-2 infection
Conditions
Interventions
Trade Name: Pulmozyme
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: DORNASE ALFA
CAS Number: 143831-71-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Con
Sponsors
Region Skåne
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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. ;Timepoint(s) of evaluation of this end point: day 1 through 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;Timepoint(s) of evaluation of this end point: day 1 throuogh 28 | — |
Countries
Sweden
Contacts
Public ContactAdam Linder
Region Skåne
Outcome results
None listed