NCT04445285 Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
| NCT ID | NCT04445285 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jon Simmons |
| Condition | Covid19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2020-04-28 |
| Primary Completion | 2021-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 44 participants in total. It began in 2020-04-28 with a primary completion date of 2021-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04445285 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Covid19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04445285 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04445285 currently recruiting?
Yes, NCT04445285 is actively recruiting participants. Contact the research team at jdsimmons@health.southalabama.edu for enrollment information.
Where is the NCT04445285 trial being conducted?
This trial is being conducted at Mobile, United States.
Who is sponsoring the NCT04445285 clinical trial?
NCT04445285 is sponsored by Jon Simmons. The trial plans to enroll 44 participants.
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