COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001849-39/SE

Region Skåne - Adam Linder

adam.linder@med.lu.se

2020-04-28

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

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.

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.

2

Region Skåne

18

100

Sweden

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

100

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.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 416, "treatment_name": "Dornase alfa", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]