Nebulized PL for Post-COVID-19 Syndrome

Covid19 Clinical Trial

Official title: Autologous Nebulized Platelet Lysate for Post COVID-19 Syndrome

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• COVID-19
• Covid19

• NCT number: NCT04487691
• Study type: Interventional
• Source: Regenexx, LLC
• Status: Terminated
• Phase: N/A
• Start date: December 8, 2020
• Completion date: June 15, 2021