RecruitingPhase 2NCT04445285

Phase 2 Trial 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

Sponsor

Jon Simmons

Enrollment

44 participants

Start Date

Apr 28, 2020

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Inclusion Criteria5

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

Exclusion Criteria4

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

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Interventions

DRUGPulmozyme/ 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

DRUG0.9%sodium chloride

Placebo of 0.9% sodium chloride every 24 hours for five (5) consecutive days; a total of 5 doses

Locations(1)

University of South Alabama

Mobile, Alabama, United States

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NCT04445285