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

Sponsor

Jon Simmons (Other)

Overall Status

Recruiting

CT.gov ID

NCT04445285

Collaborator

University of South Alabama (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) Drug: 0.9%sodium chloride	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 28, 2020

Anticipated Primary Completion Date :

Nov 30, 2021

Anticipated Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm 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) 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 Comparator: Placebo Arm 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.	Drug: 0.9%sodium chloride Placebo of 0.9% sodium chloride every 24 hours for five (5) consecutive days; a total of 5 doses

Arm

Intervention/Treatment

Experimental: Treatment Arm

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)

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 Comparator: Placebo Arm 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.

Drug: 0.9%sodium chloride

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

Outcome Measures

Primary Outcome Measures

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

Respiratory Response [28 days]
Proportion of patients alive and free of invasive mechanical ventilation at 28 days invasive mechanical ventilation 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
Respiratory Response [28 days]
Alive, respiratory failure-free days at 28 days
Pulmonary Function [5 days]
Pulmonary Function Ratio at 5 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Alabama	Mobile	Alabama	United States	36617

Sponsors and Collaborators

Jon Simmons
University of South Alabama

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Jon Simmons, Chief, Division of Trauma & Acute Care Surgery, University of South Alabama

ClinicalTrials.gov Identifier:

NCT04445285

Other Study ID Numbers:

USAH 1002 000

First Posted:

Jun 24, 2020

Last Update Posted:

May 28, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jon Simmons, Chief, Division of Trauma & Acute Care Surgery, University of South Alabama

Covid-19, Coronavirus

Additional relevant MeSH terms:

COVID-19

Respiratory Insufficiency

Study Results

No Results Posted as of May 28, 2021