What this study is
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.
What's being tested
- Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)
Intervention · DRUG
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
- 0.9%sodium chloride
Intervention · DRUG
Placebo of 0.9% sodium chloride every 24 hours for five (5) consecutive days; a total of 5 doses
Study details
- Official title
- Double Blind Randomized Phase 2 Placebo Controlled Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
- Sponsor
- Jon Simmons
- Conditions
- Covid19
- Enrolling
- 44 people
- Starts
- 2020-04-28
- Est. completion
- 2022-02-28
- Design
- Triple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Male or Female age 18 or older
- On high flow oxygen =/> 6 liters nasal cannula (or)
- On mechanical ventilation
- Clinical diagnosis of COVID-19 & positive PCR test (or)
- Clinical diagnosis of COVID-19 & negative PCR test with clinical symptoms of COVID-19 and pathognomonic lesions on a chest CT scan
You can't join if
- Known allergy to Pulmozyme
- Less than 18 years of age
- Grave condition with anticipated death within 48 hours; at the discretion of treating physician.
- Enrollment in another clinical trial receiving investigatory drugs
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of South Alabama
Mobile, Alabama, United States
- Jon Simmons, M.D. · Contact251-471-7971jsimmons@health.southalabama.edu
- Wendy Blount, RN, MSN · Contact251-445-9834wlblount@health.southalabama.edu
Recruiting
Study team
Sponsor
Jon Simmons
Study ID USAH 1002 000
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.