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

Study Overview
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Brief Summary
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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.

Official Title
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Double Blind Randomized Phase 2 Placebo Controlled Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure

Conditions
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Covid19

Intervention / Treatment
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* Drug: Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)
* Drug: 0.9%sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Patient will receive 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. | Drug: Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)<br>* 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<br>|
| Placebo Comparator: Placebo Arm 0.9% sodium chloride<br>Patient will receive 2.5ml of Sodium Chloride 0.9% aerosolized treatment once every 24 hours for five (5) consecutive days; a total of five (5) doses. | Drug: 0.9%sodium chloride<br>* Placebo of 0.9% sodium chloride every 24 hours for five (5) consecutive days; a total of 5 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at 28 days | All Cause Mortality at 28 days | 28 days after enrollment | 
| Systemic Therapeutic Response | To assess the effect of Pulmozyme® on the severity of respiratory failure, systemic inflammatory response, and multi-organ failure. | 5 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Response | Proportion of patients alive and free of invasive mechanical ventilation at 28 days invasive mechanical ventilation at 28 days | 28 days | 
| Legnth of ICU Stay | Proportion of patients alive and discharged from the ICU at 28 days discharged from the ICU at 28 days | 28 days | 
| Legnth of Hospital Stay | Proportion of patients alive and discharged from the hospital at 28 days | 28 days | 
| Respiratory Response | Alive, respiratory failure-free days at 28 days | 28 days | 
| Pulmonary Function | Pulmonary Function Ratio at 5 days | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, Coronavirus