Clinical trial NCT04487691: Nebulized PL for Post-COVID-19 Syndrome
Official title: Autologous Nebulized Platelet Lysate for Post COVID-19 Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Covid19
Lead sponsor: Regenexx, LLC
Sponsor class: INDUSTRY
First posted: 2020-07-27
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Spirometry-FVC and FEV1/FVC tests
timeFrame: 4 weeks; 8 weeks
Secondary outcomes:
measure: Spirometry-FVC and FEV1/FVC tests
timeFrame: 3 months, 6 months
measure: 6 Minute Walk Distance test (6MWD)
timeFrame: 4 weeks; 8 weeks; 3 months; 6 months
measure: Distance-desaturation product from 6MWD
timeFrame: 4 weeks; 8 weeks; 3 months; 6 months
measure: San Diego Shortness of Breath Questionnaire (SOBQ)
timeFrame: 4 weeks; 8 weeks; 3 months; 6 months
measure: Short Form-36 (SF-36)
timeFrame: 4 weeks; 8 weeks; 3 months; 6 months
measure: Modified Single Assessment Numeric Evaluation (SANE)
timeFrame: 4 weeks; 8 weeks; 3 months; 6 months
measure: Medications
timeFrame: 4 weeks; 8 weeks; 3 months; 6 months
measure: Incidence of adverse events
timeFrame: 4 weeks; 8 weeks; 3 months; 6 months
measure: Incidence of surgical/other treatment interventions
timeFrame: 4 weeks; 8 weeks; 3 months; 6 months
Other outcomes:
Locations:
city: Broomfield
country: United States
facility: Centeno-Schultz Clinic
state: Colorado
Study officials:
affiliation: Centeno-Schultz Clinic
name: Christopher Centeno, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
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