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
PHASE2 · University of South Alabama · NCT04445285
This study is testing if a new inhaled treatment called rhDNase can help reduce the risk of death in adults with severe COVID-19 who need extra oxygen or a ventilator.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of South Alabama (other) |
| Locations | 1 site (Mobile, Alabama) |
| Trial ID | NCT04445285 on ClinicalTrials.gov |
What this trial studies
This Phase 2 randomized placebo-controlled trial aims to evaluate the safety and efficacy of nebulized Dornase Alpha (rhDNase) in reducing 28-day mortality among COVID-19 patients experiencing respiratory failure. Participants will include adults requiring high-flow oxygen or mechanical ventilation, and they will be randomly assigned to receive either the treatment or a placebo. The study will assess the impact of rhDNase on patient outcomes over a specified period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of COVID-19 and requiring high-flow oxygen or mechanical ventilation.
Not a fit: Patients with known allergies to Pulmozyme or those in grave condition with anticipated death within 48 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly lower mortality rates in critically ill COVID-19 patients.
How similar studies have performed: Other studies have explored treatments for COVID-19, but the specific use of rhDNase in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mobile, Alabama
- University of South Alabama — Mobile, Alabama, United States (RECRUITING)
Study contacts
- Study coordinator: Jon D Simmons, M.D.
- Email: jdsimmons@health.southalabama.edu
- Phone: 12514459834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Covid19, Covid-19, Coronavirus