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.
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 weeks to determine effect on lung function in patients with post-COVID-19
ARDS syndrome.
20 patients randomized to Treatment group: Inhaled nebulized platelet lysate (PL) 1x daily
for eight weeks 20 patients randomized to Control group: Inhaled nebulized saline, 1x daily
for eight weeks.
Outcomes will be measured at 4-weeks, 8-weeks, 3-months, 6- months
Goals for this study are as follows:
1. Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic
nebulizer, 2-ml once per day for 4-weeks compared to saline control (Phase 1), early
treatment timepoint.
2. Investigate and compare the efficacy of autologous PL inhaled via handheld ultrasonic
nebulizer, 2-ml once per day for 8-weeks compared to saline control (Phase 1), final
treatment timepoint.
3. Investigate, compare, and monitor long term function and quality of life through
6-months for treatment arm compared to control.
Biological: Nebulized Platelet Lysate
Approximately 520 cc of autologous venous blood (within AABB guideline limits) will be drawn and platelet lysate (PL), maximizing the patients baseline platelet levels (~2-4x baseline) will be produced in a clean room setting using the Regenexx, LLC proprietary lab protocols (PL-M) utilizing a double lysis technique. From that sample, a high growth factor lysate will be created using a double lysis technique, and a sample will be retained to quantify the protein profile of the PL via ELISA quantitative analysis. The PL will be aliquoted into 56 (n=28x2) 2-ml ampules using sterile technique which will then be frozen at -20°C. The patient will unfreeze each ampule and place it into a handheld ultrasonic nebulizer and inhale the platelet lysate following the nebulizer manufacture's protocol until the treatment is completed. The treatment will be applied once a day for 8-weeks.
Other: Nebulized Sterile Saline
Approximately 520 cc of autologous venous blood (within AABB guideline limits) will be drawn and donated for research purposes to keep patient blinded to group allocation. Sterile normal saline to mimic the appearance of the platelet lysate will be aliquoted into 56 (n=28x2) 2-ml ampules using sterile technique which will then be frozen at -20°C. The patient will unfreeze each ampule and place it into a handheld ultrasonic nebulizer and inhale the sterile saline following the nebulizer manufacture's protocol until the treatment is completed. The treatment will be applied once a day for 8-weeks.
Inclusion Criteria:
1. Voluntary signature of the IRB approved Informed Consent
2. At least 4-weeks post ventilator or oxygen dependent ARDS treated for at least 48
hours in the ICU
3. Patient is stable enough to have been discharged home
4. Male or female ages 18-85
5. Two weeks to 1-year post hospital discharge
6. Ongoing activity intolerance due to dyspnea related to ARDS
7. Is independent, ambulatory, and can comply with all post-operative evaluations and
visits
8. 6-minute walk test distance of < 450 M
9. SF-36 physical component score < 60
10. ARDS caused by viral pneumonia including COVID-19 confirmed through an RNA anti-body
test
11. Normal to mild post-ARDS reactive airway disease
Exclusion Criteria:
1. Oxygen dependent on nasal canula greater than 2-L per minute
2. Dependent on inhaled corticosteroid at the discretion of the physician
3. Unable to complete any of the outcomes measured (Spirometry, 6MWD, SF-36, etc.)
4. Active known secondary bacterial or viral infection
5. Active moderate or severe post-ARDS reactive airway disease at the discretion of the
physician
6. Pre-morbid COPD
7. Medication list will be reviewed on a case by case basis to allow for flexibility as
post-COVID-19 patients' medication list may vary
8. Other medical comorbidities/conditions that may preclude participation in the study
Centeno-Schultz Clinic
Broomfield, Colorado, United States
Christopher Centeno, MD, Principal Investigator
Centeno-Schultz Clinic