NCT04445285PHASE2Recruiting
Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
Jon Simmons
Start Date
4/28/2020
Completion Date
2/28/2022
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 Criteria
Age Range: 18 years to No maximum
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
DRUG
Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)
DRUG
0.9%sodium chloride
Conditions
Covid19
Locations
University of South Alabama
Mobile, Alabama 36617
United States