NCT04487691

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

December 8, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

July 23, 2020

Last Update Submit

January 25, 2022

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Spirometry-FVC and FEV1/FVC tests

    Changes in pre and post treatment spirometry measures

    4 weeks; 8 weeks

Secondary Outcomes (9)

  • Spirometry-FVC and FEV1/FVC tests

    3 months, 6 months

  • 6 Minute Walk Distance test (6MWD)

    4 weeks; 8 weeks; 3 months; 6 months

  • Distance-desaturation product from 6MWD

    4 weeks; 8 weeks; 3 months; 6 months

  • San Diego Shortness of Breath Questionnaire (SOBQ)

    4 weeks; 8 weeks; 3 months; 6 months

  • Short Form-36 (SF-36)

    4 weeks; 8 weeks; 3 months; 6 months

  • +4 more secondary outcomes

Study Arms (2)

Platelet Lysate

EXPERIMENTAL

Inhaled nebulized platelet lysate (PL), 2-ml 1x per day for 8 weeks.

Biological: Nebulized Platelet Lysate

Saline

ACTIVE COMPARATOR

Inhaled nebulized normal sterile saline, 2-ml 1x per day for 8-weeks.

Other: Nebulized Sterile Saline

Interventions

Nebulized Platelet LysateBIOLOGICAL

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.

Platelet Lysate
Nebulized Sterile SalineOTHER

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.

Saline

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary signature of the IRB approved Informed Consent
  • At least 4-weeks post ventilator or oxygen dependent ARDS treated for at least 48 hours in the ICU
  • Patient is stable enough to have been discharged home
  • Male or female ages 18-85
  • Two weeks to 1-year post hospital discharge
  • Ongoing activity intolerance due to dyspnea related to ARDS
  • Is independent, ambulatory, and can comply with all post-operative evaluations and visits
  • minute walk test distance of \< 450 M
  • SF-36 physical component score \< 60
  • ARDS caused by viral pneumonia including COVID-19 confirmed through an RNA anti-body test
  • Normal to mild post-ARDS reactive airway disease

You may not qualify if:

  • Oxygen dependent on nasal canula greater than 2-L per minute
  • Dependent on inhaled corticosteroid at the discretion of the physician
  • Unable to complete any of the outcomes measured (Spirometry, 6MWD, SF-36, etc.)
  • Active known secondary bacterial or viral infection
  • Active moderate or severe post-ARDS reactive airway disease at the discretion of the physician
  • Pre-morbid COPD
  • Medication list will be reviewed on a case by case basis to allow for flexibility as post-COVID-19 patients' medication list may vary
  • Other medical comorbidities/conditions that may preclude participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021, United States

Location

Related Publications (9)

  • Prem K, Liu Y, Russell TW, Kucharski AJ, Eggo RM, Davies N; Centre for the Mathematical Modelling of Infectious Diseases COVID-19 Working Group; Jit M, Klepac P. The effect of control strategies to reduce social mixing on outcomes of the COVID-19 epidemic in Wuhan, China: a modelling study. Lancet Public Health. 2020 May;5(5):e261-e270. doi: 10.1016/S2468-2667(20)30073-6. Epub 2020 Mar 25.

    PMID: 32220655BACKGROUND

  • Chan KS, Pfoh ER, Denehy L, Elliott D, Holland AE, Dinglas VD, Needham DM. Construct validity and minimal important difference of 6-minute walk distance in survivors of acute respiratory failure. Chest. 2015 May;147(5):1316-1326. doi: 10.1378/chest.14-1808.

    PMID: 25742048BACKGROUND

  • Hopkins RO, Weaver LK, Collingridge D, Parkinson RB, Chan KJ, Orme JF Jr. Two-year cognitive, emotional, and quality-of-life outcomes in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2005 Feb 15;171(4):340-7. doi: 10.1164/rccm.200406-763OC. Epub 2004 Nov 12.

    PMID: 15542793BACKGROUND

  • 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

    BACKGROUND

  • Geiger S, Hirsch D, Hermann FG. Cell therapy for lung disease. Eur Respir Rev. 2017 Jun 28;26(144):170044. doi: 10.1183/16000617.0044-2017. Print 2017 Jun 30.

    PMID: 28659506BACKGROUND

  • 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.

    BACKGROUND

  • Mammoto T, Chen Z, Jiang A, Jiang E, Ingber DE, Mammoto A. Acceleration of Lung Regeneration by Platelet-Rich Plasma Extract through the Low-Density Lipoprotein Receptor-Related Protein 5-Tie2 Pathway. Am J Respir Cell Mol Biol. 2016 Jan;54(1):103-13. doi: 10.1165/rcmb.2015-0045OC.

    PMID: 26091161BACKGROUND

  • Centeno C, Markle J, Dodson E, Stemper I, Hyzy M, Williams C, Freeman M. The use of lumbar epidural injection of platelet lysate for treatment of radicular pain. J Exp Orthop. 2017 Nov 25;4(1):38. doi: 10.1186/s40634-017-0113-5.

    PMID: 29177632BACKGROUND

  • Del Fante C, Perotti C, Bonferoni MC, Rossi S, Sandri G, Ferrari F, Scudeller L, Caramella CM. Platelet lysate mucohadesive formulation to treat oral mucositis in graft versus host disease patients: a new therapeutic approach. AAPS PharmSciTech. 2011 Sep;12(3):893-9. doi: 10.1208/s12249-011-9649-3. Epub 2011 Jul 6.

    PMID: 21732159BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Christopher Centeno, MD

    Centeno-Schultz Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2020

First Posted

July 27, 2020

Study Start

December 8, 2020

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

February 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)