Nebulized PL for Post-COVID-19 Syndrome

Not Applicable

Terminated

• Conditions: Covid19

• Registration Number: NCT04487691
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-27
• Study Start: 2020-12-08
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Spirometry-FVC and FEV1/FVC tests	4 weeks; 8 weeks	Changes in pre and post treatment spirometry measures

Secondary Outcome Measures

Name	Time	Method
San Diego Shortness of Breath Questionnaire (SOBQ)	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
6 Minute Walk Distance test (6MWD)	4 weeks; 8 weeks; 3 months; 6 months	Changes in distance walked during 6MWD test from pre to post treatment
Short Form-36 (SF-36)	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
Spirometry-FVC and FEV1/FVC tests	3 months, 6 months	Changes from pre and post treatment spirometry measures
Distance-desaturation product from 6MWD	4 weeks; 8 weeks; 3 months; 6 months	Changes in distance-desaturation product from 6MWD from pre to post treatment
Modified Single Assessment Numeric Evaluation (SANE)	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
Medications	4 weeks; 8 weeks; 3 months; 6 months	changes in medications from pre to post treatment
Incidence of surgical/other treatment interventions	4 weeks; 8 weeks; 3 months; 6 months	Incidence of surgical/other treatment interventions after treatment
Incidence of adverse events	4 weeks; 8 weeks; 3 months; 6 months	Incidence of adverse events after treatment

Trial Locations

Locations (1)

Centeno-Schultz Clinic; 🇺🇸 Broomfield, Colorado, United States