Dornase Alfa for ARDS in Patients With Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2)

Completed · Phase 3

Conditions studied: SARS-CoV 2, ARDS

In brief

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.

Key facts

Study ID

NCT04402970

Run by

University of Missouri-Columbia

People needed

30

Starts

2020-06-19

Expected to finish

2020-12-31

Last updated by the study team

2021-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Hospitalized and mechanically ventilated for illness related to SARS-CoV-2
• Confirmed positive SARS-CoV-2 infection by Polymerase chain reaction (PCR)
• individual or surrogate ability to sign informed consent
• negative, urine-based pregnancy test in females

You may not qualify if…

• contraindication or intolerance to dornase alfa
• mechanical ventilation expected to be less than 48 hours
• life expectancy less than 24 hours based upon judgement of treating physician
• pregnant
• inability to obtain informed consent

Where it is running

• University of Missouri Hospital and Clinics — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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