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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Platelet Lysate 		Inhaled nebulized platelet lysate (PL), 2-ml 1x per day for 8 weeks.
  • 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.
Active Comparator
Saline 		Inhaled nebulized normal sterile saline, 2-ml 1x per 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.

Recruiting Locations

More Details

NCT ID
NCT04487691
Status
Terminated
Sponsor
Regenexx, LLC

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.