Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04445285
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 29, 2020
Sponsor:
Collaborator:
University of South Alabama
Information provided by (Responsible Party):
Jon Simmons, University of South Alabama

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 28, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Mortality at 28 days [ Time Frame: 28 days after enrollment ]
    All Cause Mortality at 28 days

  2. Systemic Therapeutic Response [ Time Frame: 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 :
  1. Respiratory Response [ Time Frame: 28 days ]
    Proportion of patients alive and free of invasive mechanical ventilation at 28 days invasive mechanical ventilation at 28 days

  2. Legnth of ICU Stay [ Time Frame: 28 days ]
    Proportion of patients alive and discharged from the ICU at 28 days discharged from the ICU at 28 days

  3. Legnth of Hospital Stay [ Time Frame: 28 days ]
    Proportion of patients alive and discharged from the hospital at 28 days

  4. Respiratory Response [ Time Frame: 28 days ]
    Alive, respiratory failure-free days at 28 days

  5. Pulmonary Function [ Time Frame: 5 days ]
    Pulmonary Function Ratio at 5 days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445285


Contacts
Layout table for location contacts
Contact: Jon D Simmons, M.D. 12514459834 jdsimmons@health.southalabama.edu
Contact: Wendy Blount, RN, MSN 2514554566 wlblount@health.southalabama.edu

Locations
Layout table for location information
United States, Alabama
University of South Alabama Recruiting
Mobile, Alabama, United States, 36617
Contact: Jon Simmons, M.D.    251-471-7971    jsimmons@health.southalabama.edu   
Contact: Wendy Blount, RN, MSN    251-445-9834    wlblount@health.southalabama.edu   
Sponsors and Collaborators
Jon Simmons
University of South Alabama
Publications:

Layout table for additonal information
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: June 24, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jon Simmons, University of South Alabama:
Covid-19, Coronavirus
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases