Nebulized PL for Post-COVID-19 Syndrome

Regenexx

Status: Terminated

Conditions: Covid19

Treatments: Biological: Nebulized Platelet Lysate; Other: Nebulized Sterile Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT04487691

RGX2020-RCT01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups

Platelet Lysate

Experimental group

Description:

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

Treatment:

Biological: Nebulized Platelet Lysate

Saline

Active Comparator group

Description:

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

Treatment:

Other: Nebulized Sterile Saline