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Recruiting Phase 2 NCT04445285

Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure

◆ AI Clinical Summary

This study tests whether a medication called Dornase Alpha (rhDNase), delivered through a nebulizer to the lungs, can help COVID-19 patients who are experiencing severe breathing problems. Researchers will compare patients who receive this medication to those who receive a placebo (inactive treatment) to see if it reduces deaths within 28 days and is safe to use.

Key Objective: The trial is testing whether nebulized rhDNase can reduce 28-day mortality and improve survival in COVID-19 patients with respiratory failure.

Who to Consider: COVID-19 patients who are hospitalized with respiratory failure and requiring supplemental oxygen or ventilator support should consider enrolling.

Trial Parameters

Condition Covid19
Sponsor Jon Simmons
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 44
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-04-28
Completion 2021-11-30
Interventions
Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)0.9%sodium chloride

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

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