Status:
TERMINATED
Nebulized PL for Post-COVID-19 Syndrome
Lead Sponsor:
Regenexx, LLC
Conditions:
Covid19
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
To evaluate and compare nebulized platelet lysate to placebo control of saline administered via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in patients with post-C...
Detailed Description
This is a double-blind, randomized, placebo controlled single-center study using nebulized platelet lysate compared to placebo control of saline administered via handheld nebulizer 1x daily for eight ...
Eligibility Criteria
Inclusion
- Voluntary signature of the IRB approved Informed Consent
- At least 4-weeks post ventilator or oxygen dependent ARDS treated for at least 48 hours in the ICU
- Patient is stable enough to have been discharged home
- Male or female ages 18-85
- Two weeks to 1-year post hospital discharge
- Ongoing activity intolerance due to dyspnea related to ARDS
- Is independent, ambulatory, and can comply with all post-operative evaluations and visits
- 6-minute walk test distance of \< 450 M
- SF-36 physical component score \< 60
- ARDS caused by viral pneumonia including COVID-19 confirmed through an RNA anti-body test
- Normal to mild post-ARDS reactive airway disease
Exclusion
- Oxygen dependent on nasal canula greater than 2-L per minute
- Dependent on inhaled corticosteroid at the discretion of the physician
- Unable to complete any of the outcomes measured (Spirometry, 6MWD, SF-36, etc.)
- Active known secondary bacterial or viral infection
- Active moderate or severe post-ARDS reactive airway disease at the discretion of the physician
- Pre-morbid COPD
- Medication list will be reviewed on a case by case basis to allow for flexibility as post-COVID-19 patients' medication list may vary
- Other medical comorbidities/conditions that may preclude participation in the study
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04487691
Start Date
December 8 2020
End Date
June 15 2021
Last Update
February 4 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centeno-Schultz Clinic
Broomfield, Colorado, United States, 80021