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NCT04402970 · ClinicalTrials.gov registry record · Phase 3
Dornase Alfa for ARDS in Patients With Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2)
A Phase 3 study, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT04402970 is a Phase 3 study that has completed, run by University of Missouri-Columbia. The registered enrollment target is 30 participants.
The verdict
NCT04402970, a Phase 3 study, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study is designed to evaluate a potential mechanism by which a hyperactive immune response may contribute to death from SARS-CoV-2; by an excessive neutrophil-mediated deposition of cell-free DNA in neutrophil extracellular traps (NET). Excessive amounts of NETs can increase rigidity of mucus, clog airways, and be agents for the development of acute respiratory distress (Narasaraju et al., Am J Pathol. 2011). Many aspects of this pathway have been observed in severe SARS-CoV-2 (Zhang et al., Respiratory research. 2020). Dornase alfa (DNAse I; Pulmozyme (Genentech) is a nebulized drug that works by degrading cell-free DNA and thus promoting airway clearance and recovery. The investigators hypothesize that by thinning mucus and degrading these NETs further lung damage may be prevented and a reduction in time to recovery may occur. The two aims of the study are to see if inhaled/nebulized dornase alfa will improve clinical outcome measures in SARS-CoV-2 related acute respiratory distress syndrome (ARDS) and to see if dornase alfa reduces the amount of bronchoalveolar lavage and blood markers of NET activity. The study will recruit patients who are on mechanical ventilation for respiratory failure related to SARS-CoV-2 positive infection and have ARDS based upon Berlin criteria. The investigators aim to recruit 10-20 patients for this study.
Interventions
- DRUG Dornase Alfa Inhalation Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-06-19 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04402970
The ClinicalTrials.gov registry entry for NCT04402970 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dornase Alfa Inhalation Solution is the first listed.
NCT04402970 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04402970 about?
NCT04402970 is a clinical study titled "Dornase Alfa for ARDS in Patients With Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2)". This study is designed to evaluate a potential mechanism by which a hyperactive immune response may contribute to death from SARS-CoV-2; by an excessive neutrophil-mediated deposition of cell-free DNA in neutrophil extracellular traps (NET). Excessive amounts of NETs can increase rigidity of mucus, ...
What is the current status of trial NCT04402970?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2020-06-19. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT04402970?
The interventions under investigation include: Dornase Alfa Inhalation Solution (DRUG).
Who is sponsoring clinical trial NCT04402970?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
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