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

May 26, 2021 updated by: Jon Simmons

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at 28 days
Time Frame: 28 days after enrollment
All Cause Mortality at 28 days
28 days after enrollment
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.
5 days after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
28 days
Legnth of Hospital Stay
Time Frame: 28 days
Proportion of patients alive and discharged from the hospital at 28 days
28 days
Respiratory Response
Time Frame: 28 days
Alive, respiratory failure-free days at 28 days
28 days
Pulmonary Function
Time Frame: 5 days
Pulmonary Function Ratio at 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jon Simmons

Collaborators

University of South Alabama

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 28, 2020

Primary Completion (ANTICIPATED)

November 30, 2021

Study Completion (ANTICIPATED)

February 28, 2022

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (ACTUAL)

June 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2021

Last Update Submitted That Met QC Criteria

May 26, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USAH 1002 000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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