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

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Jon Simmons
Study ID
NCT04445285
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Apr 28, 2020
Status verified
May 2021
Primary completion
Nov 30, 2021
Completion
Feb 28, 2022

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Mortality at 28 days [ Time Frame: 28 days after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South AlabamaMobileAlabama36617
Jon Simmons, M.D.
[email protected]
251-471-7971
Wendy Blount, RN, MSN
[email protected]
251-445-9834

Find similar trials in Mobile, AL

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
University of South Alabama· Mobile, AL

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