Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19
1 other identifier
interventional
76
1 country
1
Brief Summary
Recent observations have suggested a role of neutrophil extracellular traps (NETs) in the pathophysiology of severe COVID-19. The aim of the study is to assess efficacy and safety of aerosolized DNase I to remove NETs and decrease respiratory distress in patients with COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started Jun 2020
Longer than P75 for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 4, 2020
CompletedFirst Submitted
Initial submission to the registry
June 5, 2020
CompletedFirst Posted
Study publicly available on registry
September 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2023
CompletedAugust 6, 2024
August 1, 2024
1.6 years
June 5, 2020
August 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Time to cessation of oxygen therapy DNase I to that of placebo (NaCl, 0.9%) on time to cessation of oxygen therapy hospitalized patients with COVID-19 and respiratory dysfunction.
Number of Days to cessation of oxygen therapy after start of treatment
28 days
Secondary Outcomes (8)
28-day mortality
28 days
Number of Days alive and without ventilator treatment
28 days
Number of Days alive and without high flow nasal oxygen treatment (Optiflow)
28 days
Number of Days alive and free of stay in the ICU
28 days
Number of Days alive and outside hospital
28 days
- +3 more secondary outcomes
Study Arms (2)
Aerosolized DNase I
ACTIVE COMPARATORNaCl
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age ≥18 years old
- Admitted to hospital ward or ICU
- A positive PCR test for SARS-CoV-2 from throat swab or nasopharynx
- An oxygen saturation ≤90% after maximum 15 minutes without supplemental oxygen
- Signed informed consent
You may not qualify if:
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- Known or suspected allergy against Pulmozyme
- Chronic obstructive pulmonary disease stage III-IV or another comparable chronic respiratory disease
- Participation in a clinical study with an investigational product during the last 30 days
- Previous participation in this study
- Pregnancy. Women of childbearing potential must agree to use contraceptives for the duration of the study period
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (1)
Lund ED
Lund, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Linder, MD
Region Skåne
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- senior concultant, associate professor
Study Record Dates
First Submitted
June 5, 2020
First Posted
September 9, 2020
Study Start
June 4, 2020
Primary Completion
January 11, 2022
Study Completion
January 6, 2023
Last Updated
August 6, 2024
Record last verified: 2024-08