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Trial record 2 of 10 for:    DNAse | Covid19

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

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ClinicalTrials.gov Identifier: NCT04445285
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : May 28, 2021
Sponsor:
Collaborator:
University of South Alabama
Information provided by (Responsible Party):
Jon Simmons, University of South Alabama

Tracking Information
First Submitted Date  ICMJE June 22, 2020
First Posted Date  ICMJE June 24, 2020
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE April 28, 2020
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
  • Mortality at 28 days [ Time Frame: 28 days after enrollment ]
    All Cause Mortality at 28 days
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2020)
  • 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
  • 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
  • Legnth of Hospital Stay [ Time Frame: 28 days ]
    Proportion of patients alive and discharged from the hospital at 28 days
  • Respiratory Response [ Time Frame: 28 days ]
    Alive, respiratory failure-free days at 28 days
  • Pulmonary Function [ Time Frame: 5 days ]
    Pulmonary Function Ratio at 5 days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
Official Title  ICMJE Double Blind Randomized Phase 2 Placebo Controlled Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • 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
  • Drug: 0.9%sodium chloride
    Placebo of 0.9% sodium chloride every 24 hours for five (5) consecutive days; a total of 5 doses
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)
  • 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.
    Intervention: Drug: 0.9%sodium chloride
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2020)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2022
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jon D Simmons, M.D. 12514459834 jdsimmons@health.southalabama.edu
Contact: Wendy Blount, RN, MSN 2514554566 wlblount@health.southalabama.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04445285
Other Study ID Numbers  ICMJE USAH 1002 000
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jon Simmons, University of South Alabama
Study Sponsor  ICMJE Jon Simmons
Collaborators  ICMJE University of South Alabama
Investigators  ICMJE Not Provided
PRS Account University of South Alabama
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP