Nebulized Platelet Lysate (PL) Study

Nebulized Platelet Lysate (PL) Study Requirements

Patients must be able to visit the clinic in Broomfield, CO to see if they are a candidate and for all study visits (evaluation, 4-weeks, 8-weeks, 3 months and 6 months).

For this study, we are looking for patients that have activity intolerance due to persistent breathing difficulties from having acute respiratory distress syndrome (ARDS) which may have occurred as a result of contracting COVID-19. This is a randomized-controlled clinical trial, meaning that patients have an equal chance of being assigned to either the active treatment or the placebo control of saline. Patients enrolled into the study will be asked to complete daily doses of an inhaled treatment using a nebulizer of either platelet lysate or the saline for 8 weeks. Platelet lysate (PL) is created from a blood draw. Patients will not know which group they have been assigned.

The first round of treatment will last for 4-weeks. At that time, patients will return to the clinic to complete several tests of lung function and patient-reported questionnaires. Patients will then complete the next 4 weeks of treatment. Another set of lung function tests will be completed at 8-weeks, 3-months, and 6-months. Patients will be unblinded to which treatment they received after completing the tests at the 3-month visit.

Inclusion Criteria

Candidates must meet ALL of the following:

• 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 Criteria

Candidates will be excluded if they meet ANY of the following:

• 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

*Recruiting local patients only

If you are interested in seeing if you are a candidate for participating in this study, please email us at [email protected] or call 720-287-7199.