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Covid19Phase 2DAMPENCOVIDNCT04445285

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

A Phase 2 study testing Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) and 0.9%sodium chloride in people with Covid19, run by Jon Simmons at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) and 0.9%sodium chloride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteUnited States
Study dates
28 Apr 2020to 28 Feb 2022
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jon D Simmons, M.D. contact

12514459834

jdsimmons@health.southalabama.edu

Wendy Blount, RN, MSN contact

2514554566

wlblount@health.southalabama.edu

United States1 site, 1 recruiting

  • University of South Alabama

    Mobile, Alabama, 36617

    Jon Simmons, M.D., 251-471-7971, jsimmons@health.southalabama.edu

    Wendy Blount, RN, MSN, 251-445-9834, wlblount@health.southalabama.edu

    Recruiting

Other trials in United States

About this study

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

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.

Conditions
Covid19
Being tested
Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase), 0.9%sodium chloride
Keywords
Covid-19, Coronavirus
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)Drug

    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

  • 0.9%sodium chlorideDrug

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

Study groups in NCT04445285
Study groupRoleWhat they receive
Treatment ArmExperimentalPatient 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.
Receives: Drug: Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)
Placebo Arm 0.9% sodium chloridePlacebo comparatorPatient 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.
Receives: Drug: 0.9%sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality at 28 days

    All Cause Mortality at 28 days

    Measured: 28 days after enrollment

  2. Systemic Therapeutic Response

    To assess the effect of Pulmozyme® on the severity of respiratory failure, systemic inflammatory response, and multi-organ failure.

    Measured: 5 days after enrollment

Secondary outcomes (5)

  1. Respiratory Response

    Proportion of patients alive and free of invasive mechanical ventilation at 28 days invasive mechanical ventilation at 28 days

    Measured: 28 days

  2. Legnth of ICU Stay

    Proportion of patients alive and discharged from the ICU at 28 days discharged from the ICU at 28 days

    Measured: 28 days

  3. Legnth of Hospital Stay

    Proportion of patients alive and discharged from the hospital at 28 days

    Measured: 28 days

  4. Respiratory Response

    Alive, respiratory failure-free days at 28 days

    Measured: 28 days

  5. Pulmonary Function

    Pulmonary Function Ratio at 5 days

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2020
  2. Study start28 Apr 2020
  3. Primary completion30 Nov 2021 (estimated)
  4. Study completion28 Feb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04445285
Sponsor's protocol ID
USAH 1002 000
Acronym
DAMPENCOVID
Status last verified
May 2021
First submitted
22 Jun 2020
Last updated
28 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23979273

  • 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.

    PubMed 20203610

  • 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.

    PubMed 24748601

  • 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.

    PubMed 25795724

  • 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.

    PubMed 12060578

  • 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.

    PubMed 20969951

  • 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.

    PubMed 21890512

  • 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.

    PubMed 23154780

  • 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.

    PubMed 23241530

  • 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.

    PubMed 27787436

  • 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.

    PubMed 11350811

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) and 0.9%sodium chloride in people with Covid19, run by Jon Simmons at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jon D Simmons, M.D. (12514459834, jdsimmons@health.southalabama.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality at 28 days (time frame: 28 days after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04445285, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.

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