Clinical trial NCT04445285: Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
Official title: Double Blind Randomized Phase 2 Placebo Controlled Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Covid19
Keywords: Covid-19, Coronavirus
Lead sponsor: University of South Alabama
Sponsor class: OTHER
Collaborators: name: University of South Alabama
First posted: 2020-06-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Mortality at 28 days
timeFrame: 28 days after enrollment
measure: Systemic Therapeutic Response
timeFrame: 5 days after enrollment
Secondary outcomes:
measure: Respiratory Response
timeFrame: 28 days
measure: Legnth of ICU Stay
timeFrame: 28 days
measure: Legnth of Hospital Stay
timeFrame: 28 days
measure: Respiratory Response
timeFrame: 28 days
measure: Pulmonary Function
timeFrame: 5 days
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
Study officials:
References:
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