Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nebulized PL for Post-COVID-19 Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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
Covid19 Biological: Nebulized Platelet Lysate Other: Nebulized Sterile Saline Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Study Start Date : August 3, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 30, 2021

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.




Primary Outcome Measures :
  1. Spirometry-FVC and FEV1/FVC tests [ Time Frame: 4 weeks; 8 weeks ]
    Changes in pre and post treatment spirometry measures


Secondary Outcome Measures :
  1. Spirometry-FVC and FEV1/FVC tests [ Time Frame: 3 months, 6 months ]
    Changes from pre and post treatment spirometry measures

  2. 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

  3. 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. 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

  5. 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

  6. 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

  7. Medications [ Time Frame: 4 weeks; 8 weeks; 3 months; 6 months ]
    changes in medications from pre to post treatment

  8. Incidence of adverse events [ Time Frame: 4 weeks; 8 weeks; 3 months; 6 months ]
    Incidence of adverse events after treatment

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487691


Contacts
Layout table for location contacts
Contact: Ehren Dodson, PhD 7202877199 edodson@regenexx.com
Contact: Neven Steinmetz, PhD nsteinmetz@regenexx.com

Locations
Layout table for location information
United States, Colorado
Centeno-Schultz Clinic
Broomfield, Colorado, United States, 80021
Sponsors and Collaborators
Regenexx, LLC
Investigators
Layout table for investigator information
Principal Investigator: Christopher Centeno, MD Centeno-Schultz Clinic
Publications:
Salama SM, Kamel IH, Ghanim M, Elsherif A. (2019). The Efficacy of Autologous Nebulized Platelet Rich Plasma (PRP) As an Early Adjuvant Therapeutic and Prognostic Treatment Modality in the Management of Inhalation Lung Injury. Egypt, J Plast Reconstr Surg. 43: 203-208. 10.21608/ejprs.2019.65115
Rubio MM. (2019). Beyond the Ordinary: The Effect of Cellular Therapy on Quality of Life in Chronic Lung Disease. J Clin Res Med. 2(4): 1-8. https://researchopenworld.com/beyond-the-ordinary-the-effect-of-cellular-therapy-on-quality-of-life-in-chronic-lung-disease/ Accessed 3/27/20.

Layout table for additonal information
Responsible Party: Regenexx, LLC
ClinicalTrials.gov Identifier: NCT04487691    
Other Study ID Numbers: RGX2020-RCT01
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No