Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
Purpose
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.
Condition
- Covid19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Arm |
Patient will receive 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 Comparator Placebo Arm 0.9% sodium chloride |
Patient will receive 2.5ml of Sodium Chloride 0.9% aerosolized treatment once every 24 hours for five (5) consecutive days; a total of five (5) doses. |
|
Recruiting Locations
University of South Alabama
Mobile, Alabama 36617
Mobile, Alabama 36617
More Details
- NCT ID
- NCT04445285
- Status
- Recruiting
- Sponsor
- Jon Simmons