COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04487691

Ehren Dodson, PhD

edodson@regenexx.com

2020-07-27

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Long covid

inclusion criteria: voluntary signature of the irb approved informed consent 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 is independent, ambulatory, and can comply with all post-operative evaluations and visits 6-minute walk test distance of < 450 m sf-36 physical component score < 60 ards caused by viral pneumonia including covid-19 confirmed through an rna anti-body test normal to mild post-ards reactive airway disease

oxygen dependent on nasal canula greater than 2-l per minute dependent on inhaled corticosteroid at the discretion of the physician unable to complete any of the outcomes measured (spirometry, 6mwd, sf-36, etc.) active known secondary bacterial or viral infection active moderate or severe post-ards reactive airway disease at the discretion of the physician pre-morbid copd medication list will be reviewed on a case by case basis to allow for flexibility as post-covid-19 patients' medication list may vary other medical comorbidities/conditions that may preclude participation in the study

2

Regenexx, LLC

18

85

United States

Patients recovered from covid

N/A

1

Spirometry-FVC and FEV1/FVC tests

None

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 874, "treatment_name": "Nebulized platelet lysate", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]