This Phase 2 Randomized Placebo Controlled Trial will determine if administering nebulized Dornase Alpha (rhDNase) to COVID-19 patients with respiratory failure is safe and will reduce 28-day mortality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
2.5mg Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) aerosolized treatment once every 24 hours for five (5) consecutive days; a total of five (5) doses
Placebo of 0.9% sodium chloride every 24 hours for five (5) consecutive days; a total of 5 doses
University of South Alabama
Mobile, Alabama, United States
RECRUITINGMortality at 28 days
All Cause Mortality at 28 days
Time frame: 28 days after enrollment
Systemic Therapeutic Response
To assess the effect of Pulmozyme® on the severity of respiratory failure, systemic inflammatory response, and multi-organ failure.
Time frame: 5 days after enrollment
Respiratory Response
Proportion of patients alive and free of invasive mechanical ventilation at 28 days invasive mechanical ventilation at 28 days
Time frame: 28 days
Legnth of ICU Stay
Proportion of patients alive and discharged from the ICU at 28 days discharged from the ICU at 28 days
Time frame: 28 days
Legnth of Hospital Stay
Proportion of patients alive and discharged from the hospital at 28 days
Time frame: 28 days
Respiratory Response
Alive, respiratory failure-free days at 28 days
Time frame: 28 days
Pulmonary Function
Pulmonary Function Ratio at 5 days
Time frame: 5 days
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