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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1
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.
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.
Centeno-Schultz Clinic
Broomfield, Colorado, United States
Spirometry-FVC and FEV1/FVC tests
Changes in pre and post treatment spirometry measures
Time frame: 4 weeks; 8 weeks
Spirometry-FVC and FEV1/FVC tests
Changes from pre and post treatment spirometry measures
Time frame: 3 months, 6 months
6 Minute Walk Distance test (6MWD)
Changes in distance walked during 6MWD test from pre to post treatment
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
Distance-desaturation product from 6MWD
Changes in distance-desaturation product from 6MWD from pre to post treatment
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
San Diego Shortness of Breath Questionnaire (SOBQ)
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
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
Short Form-36 (SF-36)
Changes in SF-36 scores from pre to post treatment; 8 subscales 0-100 range where lower scores equal more disability
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
Modified Single Assessment Numeric Evaluation (SANE)
Average SANE score post treatment; scores range from 0-100 where 0=no improvement and 100=100% improvement in breathing condition
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
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Medications
changes in medications from pre to post treatment
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
Incidence of adverse events
Incidence of adverse events after treatment
Time frame: 4 weeks; 8 weeks; 3 months; 6 months
Incidence of surgical/other treatment interventions
Incidence of surgical/other treatment interventions after treatment
Time frame: 4 weeks; 8 weeks; 3 months; 6 months