Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04445285

Phase 2 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of South Alabama

Mobile, Alabama, 36617, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 chloride

Drug

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

Primary outcomes

  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 outcomes

  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

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Jon Simmons

Other

Collaborators

  • University of South Alabama

Registry information

Official study title

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

Acronym: DAMPENCOVID

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 24, 2020
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.