Covid 19 Clinical Trials

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 20 patients for this study.

NCT04402970 SARS-CoV 2 ARDS Drug: Dornase Alfa Inhalation Solution

Primary Outcomes

Description: Daily evaluation of PaO2/FiO2 ratio on the day prior to starting therapy and then repeat daily for 14 days after starting therapy.

Measure: Improvement in PaO2/FiO2

Time: 14 days

Secondary Outcomes

Description: Daily evaluation of static lung compliance, measured by change in driving pressure over volume delivered, on the day prior to starting therapy and then repeated daily for 14 days after the first dose of therapy.

Measure: Change in static lung compliance

Time: 14 days

Description: Number of days on mechanical ventilation

Measure: Duration of mechanical ventilation

Time: From date of randomization until extubation or date of death from any cause, whichever came first, assessed up to 12 months

Description: Number of days in the medical intensive care unti

Measure: Length of ICU stay

Time: From date of randomization until discharge/transfer out of the ICU or date of death from any cause, whichever came first, assessed up to 12 months

Description: Number of days as an inpatient at the University of Missouri

Measure: Length of hospitalization

Time: From date of randomization until discharge from acute care hospital or date of death from any cause, whichever came first, assessed up to 12 months

Description: Determination of secondary bacterial infections based upon positive culture results and clinical diagnosis by treating physician.

Measure: Secondary bacterial infections

Time: From date of randomization until first positive culture or clinical diagnosis of infection if occurs, assessed up to 3 months

Description: All cause mortality

Measure: Mortality

Time: Evaluation at 30 and 90 days

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (1)

Correlated MeSH Terms (4)

Correlated HPO Terms (2)

Clinical Trials

1 Inhaled Dornase Alfa for Treatment of ARDS in Patients With SARS-CoV-2

NCT04402970 SARS-CoV 2 ARDS Drug: Dornase Alfa Inhalation Solution

Primary Outcomes

Secondary Outcomes

No related HPO nodes (Using clinical trials)