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

Phase 2

Recruiting

• Conditions: Covid19
• Interventions: Drug: Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase); Drug: 0.9%sodium chloride

• Registration Number: NCT04445285
• Lead Sponsor: Jon Simmons

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-28
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-28
• Primary Completion: 2021-11-30
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)	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.
Placebo Arm 0.9% sodium chloride	0.9%sodium chloride	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Respiratory Response	28 days	Alive, respiratory failure-free days at 28 days
Legnth of ICU Stay	28 days	Proportion of patients alive and discharged from the ICU at 28 days discharged from the ICU at 28 days
Legnth of Hospital Stay	28 days	Proportion of patients alive and discharged from the hospital at 28 days
Pulmonary Function	5 days	Pulmonary Function Ratio at 5 days

Trial Locations

Locations (1)

University of South Alabama; 🇺🇸 Mobile, Alabama, United States