Treatment of COVID-19 with the inhalation drug pulmozyme
- Conditions
- SARS-coronavirus-2 infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001849-39-SE
- Lead Sponsor
- Region Skåne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method