Official Title
Double Blind Randomized Phase 2 Placebo Controlled Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
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.

Recruiting
COVID19

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

University of South Alabama
Mobile, Alabama, United States

Investigator: Jon Simmons, M.D.
Contact: 251-471-7971
jsimmons@health.southalabama.edu

Contacts

Jon D Simmons, M.D.
12514459834
jdsimmons@health.southalabama.edu

Wendy Blount, RN, MSN
2514554566
wlblount@health.southalabama.edu

University of South Alabama
NCT Number
Keywords
Covid-19, Coronavirus
MeSH Terms
COVID-19
Respiratory Insufficiency