Recruiting
Phase 2

Dornase Alpha

Sponsor:

Jon Simmons

Code:

NCT04445285

Conditions

Covid19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)

0.9%sodium chloride

Study Details

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.

Conditions

Covid19

Study ID

NCT04445285

Start date

Apr 28, 2020

Status verified date

May, 2021

Completion date

Feb 28, 2022

Anticipated

Primary completion date

Nov 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

0.9%sodium chloride

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

Primary outcome measure

  • Mortality at 28 days [ Time Frame: 28 days after enrollment ]
  • Systemic Therapeutic Response [ Time Frame: 5 days after enrollment ]

Central Contacts and Locations

Central contacts

Jon D Simmons, M.D.

12514459834jdsimmons@health.southalabama.edu

Wendy Blount, RN, MSN

2514554566wlblount@health.southalabama.edu

Locations

University of South Alabama

Recruiting

Mobile, Alabama, United States, 36617

Contacts

Jon Simmons, M.D.

251-471-7971jsimmons@health.southalabama.edu

Wendy Blount, RN, MSN

251-445-9834wlblount@health.southalabama.edu

More Information

Sponsor

Jon Simmons

Last update posted

May 28, 2021

Last verified

May, 2021

Keywords

  • Covid-19, Coronavirus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jon Simmons on 2021-05-28.