Back to resultsPhase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure (DAMPENCOVID)
Primary Purpose
Covid19
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)
0.9%sodium chloride
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring Covid-19, Coronavirus
Eligibility Criteria
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
Sites / Locations
- University of South AlabamaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Arm
Placebo Arm 0.9% sodium chloride
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Mortality at 28 days
All Cause Mortality at 28 days
Systemic Therapeutic Response
To assess the effect of Pulmozyme® on the severity of respiratory failure, systemic inflammatory response, and multi-organ failure.
Secondary Outcome Measures
Respiratory Response
Proportion of patients alive and free of invasive mechanical ventilation at 28 days invasive mechanical ventilation at 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
Legnth of Hospital Stay
Proportion of patients alive and discharged from the hospital at 28 days
Respiratory Response
Alive, respiratory failure-free days at 28 days
Pulmonary Function
Pulmonary Function Ratio at 5 days
Full Information
NCT ID
NCT04445285
First Posted
June 22, 2020
Last Updated
May 26, 2021
Sponsor
Jon Simmons
Collaborators
University of South Alabama
1. Study Identification
Unique Protocol Identification Number
NCT04445285
Brief Title
Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
Acronym
DAMPENCOVID
Official Title
Double Blind Randomized Phase 2 Placebo Controlled Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jon Simmons
Collaborators
University of South Alabama
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Covid-19, Coronavirus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Arm 0.9% sodium chloride
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)
Intervention Description
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 Type
Drug
Intervention Name(s)
0.9%sodium chloride
Intervention Description
Placebo of 0.9% sodium chloride every 24 hours for five (5) consecutive days; a total of 5 doses
Primary Outcome Measure Information:
Title
Mortality at 28 days
Description
All Cause Mortality at 28 days
Time Frame
28 days after enrollment
Title
Systemic Therapeutic Response
Description
To assess the effect of Pulmozyme® on the severity of respiratory failure, systemic inflammatory response, and multi-organ failure.
Time Frame
5 days after enrollment
Secondary Outcome Measure Information:
Title
Respiratory Response
Description
Proportion of patients alive and free of invasive mechanical ventilation at 28 days invasive mechanical ventilation at 28 days
Time Frame
28 days
Title
Legnth of ICU Stay
Description
Proportion of patients alive and discharged from the ICU at 28 days discharged from the ICU at 28 days
Time Frame
28 days
Title
Legnth of Hospital Stay
Description
Proportion of patients alive and discharged from the hospital at 28 days
Time Frame
28 days
Title
Respiratory Response
Description
Alive, respiratory failure-free days at 28 days
Time Frame
28 days
Title
Pulmonary Function
Description
Pulmonary Function Ratio at 5 days
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jon D Simmons, M.D.
Phone
12514459834
Email
jdsimmons@health.southalabama.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Blount, RN, MSN
Phone
2514554566
Email
wlblount@health.southalabama.edu
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jon Simmons, M.D.
Phone
251-471-7971
Email
jsimmons@health.southalabama.edu
First Name & Middle Initial & Last Name & Degree
Wendy Blount, RN, MSN
Phone
251-445-9834
Email
wlblount@health.southalabama.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23979273
Citation
Simmons JD, Lee YL, Mulekar S, Kuck JL, Brevard SB, Gonzalez RP, Gillespie MN, Richards WO. Elevated levels of plasma mitochondrial DNA DAMPs are linked to clinical outcome in severely injured human subjects. Ann Surg. 2013 Oct;258(4):591-6; discussion 596-8. doi: 10.1097/SLA.0b013e3182a4ea46.
Results Reference
background
PubMed Identifier
20203610
Citation
Zhang Q, Raoof M, Chen Y, Sumi Y, Sursal T, Junger W, Brohi K, Itagaki K, Hauser CJ. Circulating mitochondrial DAMPs cause inflammatory responses to injury. Nature. 2010 Mar 4;464(7285):104-7. doi: 10.1038/nature08780.
Results Reference
background
PubMed Identifier
24748601
Citation
Schumacker PT, Gillespie MN, Nakahira K, Choi AM, Crouser ED, Piantadosi CA, Bhattacharya J. Mitochondria in lung biology and pathology: more than just a powerhouse. Am J Physiol Lung Cell Mol Physiol. 2014 Jun 1;306(11):L962-74. doi: 10.1152/ajplung.00073.2014. Epub 2014 Apr 18.
Results Reference
background
PubMed Identifier
25795724
Citation
Kuck JL, Obiako BO, Gorodnya OM, Pastukh VM, Kua J, Simmons JD, Gillespie MN. Mitochondrial DNA damage-associated molecular patterns mediate a feed-forward cycle of bacteria-induced vascular injury in perfused rat lungs. Am J Physiol Lung Cell Mol Physiol. 2015 May 15;308(10):L1078-85. doi: 10.1152/ajplung.00015.2015. Epub 2015 Mar 20.
Results Reference
background
PubMed Identifier
12060578
Citation
Dobson AW, Grishko V, LeDoux SP, Kelley MR, Wilson GL, Gillespie MN. Enhanced mtDNA repair capacity protects pulmonary artery endothelial cells from oxidant-mediated death. Am J Physiol Lung Cell Mol Physiol. 2002 Jul;283(1):L205-10. doi: 10.1152/ajplung.00443.2001.
Results Reference
background
PubMed Identifier
20969951
Citation
Ruchko MV, Gorodnya OM, Zuleta A, Pastukh VM, Gillespie MN. The DNA glycosylase Ogg1 defends against oxidant-induced mtDNA damage and apoptosis in pulmonary artery endothelial cells. Free Radic Biol Med. 2011 May 1;50(9):1107-13. doi: 10.1016/j.freeradbiomed.2010.10.692. Epub 2010 Oct 20.
Results Reference
background
PubMed Identifier
21890512
Citation
Chouteau JM, Obiako B, Gorodnya OM, Pastukh VM, Ruchko MV, Wright AJ, Wilson GL, Gillespie MN. Mitochondrial DNA integrity may be a determinant of endothelial barrier properties in oxidant-challenged rat lungs. Am J Physiol Lung Cell Mol Physiol. 2011 Dec;301(6):L892-8. doi: 10.1152/ajplung.00210.2011. Epub 2011 Sep 2.
Results Reference
background
PubMed Identifier
23154780
Citation
Gebb SA, Decoux A, Waggoner A, Wilson GL, Gillespie MN. Mitochondrial DNA damage mediates hyperoxic dysmorphogenesis in rat fetal lung explants. Neonatology. 2013;103(2):91-7. doi: 10.1159/000342632. Epub 2012 Nov 15.
Results Reference
background
PubMed Identifier
23241530
Citation
Hashizume M, Mouner M, Chouteau JM, Gorodnya OM, Ruchko MV, Potter BJ, Wilson GL, Gillespie MN, Parker JC. Mitochondrial-targeted DNA repair enzyme 8-oxoguanine DNA glycosylase 1 protects against ventilator-induced lung injury in intact mice. Am J Physiol Lung Cell Mol Physiol. 2013 Feb 15;304(4):L287-97. doi: 10.1152/ajplung.00071.2012. Epub 2012 Dec 14.
Results Reference
background
PubMed Identifier
27787436
Citation
Simmons JD, Freno DR, Muscat CA, Obiako B, Lee YL, Pastukh VM, Brevard SB, Gillespie MN. Mitochondrial DNA damage associated molecular patterns in ventilator-associated pneumonia: Prevention and reversal by intratracheal DNase I. J Trauma Acute Care Surg. 2017 Jan;82(1):120-125. doi: 10.1097/TA.0000000000001269.
Results Reference
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PubMed Identifier
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Citation
Grishko V, Solomon M, Wilson GL, LeDoux SP, Gillespie MN. Oxygen radical-induced mitochondrial DNA damage and repair in pulmonary vascular endothelial cell phenotypes. Am J Physiol Lung Cell Mol Physiol. 2001 Jun;280(6):L1300-8. doi: 10.1152/ajplung.2001.280.6.L1300.
Results Reference
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Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
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