Nebulized PL for Post-COVID-19 Syndrome
Stopped early · Not applicable
Conditions studied: Covid19
In brief
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-COVID-19 ARDS syndrome.
Key facts
- Study ID
- NCT04487691
- Run by
- Regenexx, LLC
- People needed
- 1
- Starts
- 2020-12-08
- Expected to finish
- 2021-06-15
- Last updated by the study team
- 2022-02-04
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Centeno-Schultz Clinic — Broomfield, Colorado, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.