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Nebulized PL for Post-COVID-19 Syndrome

Sponsor
Regenexx, LLC (Industry)
Overall Status
Terminated
CT.gov ID
NCT04487691
Collaborator
(none)
1
Enrollment
1
Location
2
Arms
6.2
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Nebulized Platelet Lysate
  • Other: Nebulized Sterile Saline
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Autologous Nebulized Platelet Lysate for Post COVID-19 Syndrome
Actual Study Start Date :
Dec 8, 2020
Actual Primary Completion Date :
Jun 15, 2021
Actual Study Completion Date :
Jun 15, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Spirometry-FVC and FEV1/FVC tests [4 weeks; 8 weeks]

    Changes in pre and post treatment spirometry measures

Secondary Outcome Measures

  1. Spirometry-FVC and FEV1/FVC tests [3 months, 6 months]

    Changes from pre and post treatment spirometry measures

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Medications [4 weeks; 8 weeks; 3 months; 6 months]

    changes in medications from pre to post treatment

  8. Incidence of adverse events [4 weeks; 8 weeks; 3 months; 6 months]

    Incidence of adverse events after treatment

  9. Incidence of surgical/other treatment interventions [4 weeks; 8 weeks; 3 months; 6 months]

    Incidence of surgical/other treatment interventions after treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centeno-Schultz Clinic Broomfield Colorado United States 80021

Sponsors and Collaborators

  • Regenexx, LLC

Investigators

  • Principal Investigator: Christopher Centeno, MD, Centeno-Schultz Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Regenexx, LLC
ClinicalTrials.gov Identifier:
NCT04487691
Other Study ID Numbers:
  • RGX2020-RCT01
First Posted:
Jul 27, 2020
Last Update Posted:
Feb 4, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Feb 4, 2022