Clinical Trial 44186

Broomfield, CO 80021


Summary:

Double-blind, randomized, placebo-controlled single-center study. 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 Acute Respiratory Disease Syndrome (ARDS).

Platelet lysate will be created from your own blood.

Enrolled participants will have in-person follow-up visits at the clinical site at 1-month, 2-months, 3-months and 6-months from the start of the study.

Only enrolling patients local to the Denver, CO area or surrounding 50 miles.

Criteria:

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

ARDS caused by COVID-19 confirmed through an RNA anti-body test

(other criteria apply)


Qualified Participants May Receive:

Participants in the treatment group will receive 8 weeks of treatment. Participants in the control group will receive saline control treatment. Participants in the control group will have opportunity to receive study treatment after study completion if it is deemed safe and effective.

 


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.