RECRUITINGPhase 2INTERVENTIONAL
Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
Double Blind Randomized Phase 2 Placebo Controlled Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Pulmozyme/ 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
DRUG
0.9%sodium chloride
Placebo of 0.9% sodium chloride every 24 hours for five (5) consecutive days; a total of 5 doses
Locations (1)
University of South Alabama
Mobile, Alabama, United States