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Nebulized PL for Post-COVID-19 Syndrome

Primary Purpose

Covid19

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nebulized Platelet Lysate

Nebulized Sterile Saline

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
6-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

Exclusion Criteria:

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

Sites / Locations

Centeno-Schultz Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Platelet Lysate

Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Spirometry-FVC and FEV1/FVC tests

Changes in pre and post treatment spirometry measures

Secondary Outcome Measures

Spirometry-FVC and FEV1/FVC tests

Changes from pre and post treatment spirometry measures

6 Minute Walk Distance test (6MWD)

Changes in distance walked during 6MWD test from pre to post treatment

Distance-desaturation product from 6MWD

Changes in distance-desaturation product from 6MWD from pre to post treatment

San Diego Shortness of Breath Questionnaire (SOBQ)

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)

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)

Average SANE score post treatment; scores range from 0-100 where 0=no improvement and 100=100% improvement in breathing condition

Medications

changes in medications from pre to post treatment

Incidence of adverse events

Incidence of adverse events after treatment

Incidence of surgical/other treatment interventions

Incidence of surgical/other treatment interventions after treatment

Full Information

NCT ID

NCT04487691

First Posted

July 23, 2020

Last Updated

January 25, 2022

Sponsor

Regenexx, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04487691

Brief Title

Nebulized PL for Post-COVID-19 Syndrome

Official Title

Autologous Nebulized Platelet Lysate for Post COVID-19 Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Terminated

Why Stopped

Low enrollment

Study Start Date

December 8, 2020 (Actual)

Primary Completion Date

June 15, 2021 (Actual)

Study Completion Date

June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regenexx, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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: 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. 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. Investigate, compare, and monitor long term function and quality of life through 6-months for treatment arm compared to control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Platelet Lysate

Arm Type

Experimental

Arm Description

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

Arm Title

Saline

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Nebulized Platelet Lysate

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Nebulized Sterile Saline

Intervention Description

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 Measure Information:

Title

Spirometry-FVC and FEV1/FVC tests

Description

Changes in pre and post treatment spirometry measures

Time Frame

4 weeks; 8 weeks

Secondary Outcome Measure Information:

Title

Spirometry-FVC and FEV1/FVC tests

Description

Changes from pre and post treatment spirometry measures

Time Frame

3 months, 6 months

Title

6 Minute Walk Distance test (6MWD)

Description

Changes in distance walked during 6MWD test from pre to post treatment

Time Frame