Nebulized PL for Post-COVID-19 Syndrome

January 25, 2022 updated by: Regenexx, LLC

Autologous Nebulized Platelet Lysate for Post COVID-19 Syndrome

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Broomfield, Colorado, United States, 80021
        • Centeno-Schultz Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry-FVC and FEV1/FVC tests
Time Frame: 4 weeks; 8 weeks
Changes in pre and post treatment spirometry measures
4 weeks; 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry-FVC and FEV1/FVC tests
Time Frame: 3 months, 6 months
Changes from pre and post treatment spirometry measures
3 months, 6 months
6 Minute Walk Distance test (6MWD)
Time Frame: 4 weeks; 8 weeks; 3 months; 6 months
Changes in distance walked during 6MWD test from pre to post treatment
4 weeks; 8 weeks; 3 months; 6 months
Distance-desaturation product from 6MWD
Time Frame: 4 weeks; 8 weeks; 3 months; 6 months
Changes in distance-desaturation product from 6MWD from pre to post treatment
4 weeks; 8 weeks; 3 months; 6 months
San Diego Shortness of Breath Questionnaire (SOBQ)
Time Frame: 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
4 weeks; 8 weeks; 3 months; 6 months
Short Form-36 (SF-36)
Time Frame: 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
4 weeks; 8 weeks; 3 months; 6 months
Modified Single Assessment Numeric Evaluation (SANE)
Time Frame: 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
4 weeks; 8 weeks; 3 months; 6 months
Medications
Time Frame: 4 weeks; 8 weeks; 3 months; 6 months
changes in medications from pre to post treatment
4 weeks; 8 weeks; 3 months; 6 months
Incidence of adverse events
Time Frame: 4 weeks; 8 weeks; 3 months; 6 months
Incidence of adverse events after treatment
4 weeks; 8 weeks; 3 months; 6 months
Incidence of surgical/other treatment interventions
Time Frame: 4 weeks; 8 weeks; 3 months; 6 months
Incidence of surgical/other treatment interventions after treatment
4 weeks; 8 weeks; 3 months; 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regenexx, LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2020

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 24, 2020

First Posted (Actual)

July 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGX2020-RCT01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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