Double Blind Randomized Phase 2 Placebo Controlled Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
Jon Simmons
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or Female age 18 or older 2. On high flow oxygen =/\> 6 liters nasal cannula (or) 3. On mechanical ventilation 4. Clinical diagnosis of COVID-19 \& positive PCR test (or) 5. Clinical diagnosis of COVID-19 \& negative PCR test with clinical symptoms of COVID-19 and pathognomonic lesions on a chest CT scan Exclusion Criteria: 1. Known allergy to Pulmozyme 2. Less than 18 years of age 3. Grave condition with anticipated death within 48 hours; at the discretion of treating physician. 4. Enrollment in another clinical trial receiving investigatory drugs
Interventions
- DrugPulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)
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
- Drug0.9%sodium chloride
Placebo of 0.9% sodium chloride every 24 hours for five (5) consecutive days; a total of 5 doses
Location
- University of South AlabamaMobile, Alabama