Covid19
Conditions
Keywords
Covid-19, Coronavirus
Brief 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.
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
Placebo of 0.9% sodium chloride every 24 hours for five (5) consecutive days; a total of 5 doses
Sponsors
University of South Alabama
Jon Simmons
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality at 28 days | 28 days after enrollment | All Cause Mortality at 28 days |
| Systemic Therapeutic Response | 5 days after enrollment | To assess the effect of Pulmozyme® on the severity of respiratory failure, systemic inflammatory response, and multi-organ failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Response | 28 days | Proportion of patients alive and free of invasive mechanical ventilation at 28 days invasive mechanical ventilation at 28 days |
| Legnth of ICU Stay | 28 days | Proportion of patients alive and discharged from the ICU at 28 days discharged from the ICU at 28 days |
| Legnth of Hospital Stay | 28 days | Proportion of patients alive and discharged from the hospital at 28 days |
| Pulmonary Function | 5 days | Pulmonary Function Ratio at 5 days |
Countries
United States
Contacts
Primary ContactJon D Simmons, M.D.
Backup ContactWendy Blount, RN, MSN
Outcome results
None listed