Covid19
Conditions
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-COVID-19 ARDS syndrome.
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 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.
Interventions
BIOLOGICALNebulized 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.
OTHERNebulized 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.
Sponsors
Regenexx, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spirometry-FVC and FEV1/FVC tests | 4 weeks; 8 weeks | Changes in pre and post treatment spirometry measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walk Distance test (6MWD) | 4 weeks; 8 weeks; 3 months; 6 months | Changes in distance walked during 6MWD test from pre to post treatment |
| Distance-desaturation product from 6MWD | 4 weeks; 8 weeks; 3 months; 6 months | Changes in distance-desaturation product from 6MWD from pre to post treatment |
| San Diego Shortness of Breath Questionnaire (SOBQ) | 4 weeks; 8 weeks; 3 months; 6 months | Changes in San Diego Shortness of Breath Questionnaire (SOBQ) score from pre to post; treatment; scores range from 0-120 with higher scores equaling greater breathing impairment |
| Short Form-36 (SF-36) | 4 weeks; 8 weeks; 3 months; 6 months | Changes in SF-36 scores from pre to post treatment; 8 subscales 0-100 range where lower scores equal more disability |
| Spirometry-FVC and FEV1/FVC tests | 3 months, 6 months | Changes from pre and post treatment spirometry measures |
| Medications | 4 weeks; 8 weeks; 3 months; 6 months | changes in medications from pre to post treatment |
| Incidence of adverse events | 4 weeks; 8 weeks; 3 months; 6 months | Incidence of adverse events after treatment |
| Incidence of surgical/other treatment interventions | 4 weeks; 8 weeks; 3 months; 6 months | Incidence of surgical/other treatment interventions after treatment |
| Modified Single Assessment Numeric Evaluation (SANE) | 4 weeks; 8 weeks; 3 months; 6 months | Average SANE score post treatment; scores range from 0-100 where 0=no improvement and 100=100% improvement in breathing condition |
Countries
United States
Outcome results
None listed