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Nebulized PL for Post-COVID-19 Syndrome

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ClinicalTrials.gov Identifier: NCT04487691
Recruitment Status : Not yet recruiting
First Posted : July 27, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Regenexx, LLC

Tracking Information
First Submitted Date  ICMJE July 23, 2020
First Posted Date  ICMJE July 27, 2020
Last Update Posted Date August 5, 2020
Estimated Study Start Date  ICMJE August 3, 2020
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
Spirometry-FVC and FEV1/FVC tests [ Time Frame: 4 weeks; 8 weeks ]
Changes in pre and post treatment spirometry measures
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • Spirometry-FVC and FEV1/FVC tests [ Time Frame: 3 months, 6 months ]
    Changes from pre and post treatment spirometry measures
  • 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
  • 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
  • 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
  • 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
  • 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
  • Medications [ Time Frame: 4 weeks; 8 weeks; 3 months; 6 months ]
    changes in medications from pre to post treatment
  • Incidence of adverse events [ Time Frame: 4 weeks; 8 weeks; 3 months; 6 months ]
    Incidence of adverse events after treatment
  • Incidence of surgical/other treatment interventions [ Time Frame: 4 weeks; 8 weeks; 3 months; 6 months ]
    Incidence of surgical/other treatment interventions after treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2020)
  • Spirometry-FVC and FEV1/FVC tests [ Time Frame: 3 months, 6 months ]
    Changes from pre and post treatment spirometry measures
  • 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
  • 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
  • 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
  • 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
  • Modified Single Assessment Numeric Evaluation (SANE) [ Time Frame: 4 weeks; 8 weeks; 3 months; 6 months ]
    Average SANE score post treatment
  • Medications [ Time Frame: 4 weeks; 8 weeks; 3 months; 6 months ]
    changes in medications from pre to post treatment
  • Incidence of adverse events [ Time Frame: 4 weeks; 8 weeks; 3 months; 6 months ]
    Incidence of adverse events after treatment
  • Incidence of surgical/other treatment interventions [ Time Frame: 4 weeks; 8 weeks; 3 months; 6 months ]
    Incidence of surgical/other treatment interventions after treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nebulized PL for Post-COVID-19 Syndrome
Official Title  ICMJE Autologous Nebulized Platelet Lysate for Post COVID-19 Syndrome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Platelet Lysate
    Inhaled nebulized platelet lysate (PL), 2-ml 1x per day for 8 weeks.
    Intervention: Biological: Nebulized Platelet Lysate
  • Active Comparator: Saline
    Inhaled nebulized normal sterile saline, 2-ml 1x per day for 8-weeks.
    Intervention: Other: Nebulized Sterile Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ehren Dodson, PhD 7202877199 edodson@regenexx.com
Contact: Neven Steinmetz, PhD nsteinmetz@regenexx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04487691
Other Study ID Numbers  ICMJE RGX2020-RCT01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Regenexx, LLC
Study Sponsor  ICMJE Regenexx, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Centeno, MD Centeno-Schultz Clinic
PRS Account Regenexx, LLC
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP