RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-04-28
Study Completion:2022-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04445285

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or Female age 18 or older
  2. 2. On high flow oxygen =/\> 6 liters nasal cannula (or)
  3. 3. On mechanical ventilation
  4. 4. Clinical diagnosis of COVID-19 \& positive PCR test (or)
  5. 5. Clinical diagnosis of COVID-19 \& negative PCR test with clinical symptoms of COVID-19 and pathognomonic lesions on a chest CT scan
  1. 1. Known allergy to Pulmozyme
  2. 2. Less than 18 years of age
  3. 3. Grave condition with anticipated death within 48 hours; at the discretion of treating physician.
  4. 4. Enrollment in another clinical trial receiving investigatory drugs

Contacts and Locations

Study Contact

Jon D Simmons, M.D.
CONTACT
12514459834
jdsimmons@health.southalabama.edu
Wendy Blount, RN, MSN
CONTACT
2514554566
wlblount@health.southalabama.edu

Study Locations (Sites)

University of South Alabama
Mobile, Alabama, 36617
United States

Collaborators and Investigators

Sponsor: Jon Simmons

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 Registration Dates

Study Start Date2020-04-28
Study Completion Date2022-02-28

Study Record Updates

Study Start Date2020-04-28
Study Completion Date2022-02-28

Terms related to this study

Keywords Provided by Researchers

  • Covid-19, Coronavirus

Additional Relevant MeSH Terms

  • Covid19