Status:
UNKNOWN
Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 Infection
Lead Sponsor:
Black Tie Medical, Inc.
Collaborating Sponsors:
Robert W. Alexander, MD
Conditions:
Pulmonary Alveolar Proteinosis
COPD
Eligibility:
All Genders
18-90 years
Phase:
EARLY_PHASE1
Brief Summary
COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure a...
Detailed Description
COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure a...
Eligibility Criteria
Inclusion
- Must have confirmed and documented Coronaviral (COVID-19) infection history with involvement of lung tissues
- Must be clear of any viral shed residual confirmed by negative viral testing protocol accepted by the Center for Disease Control (CDC) and/or the FDA
- Must have discharge confirmation from infectious disease managing Provider declaring freedom of viral load or active infection
- Must have a written Medical History of Physical and discharge summary (if hospitalized) from appropriate Center or Licensed Medical Provider
- Must agree to provide a HRCT LUNG study done at baseline (before), 3 months and 6 months
- Must be able to provide full Informed Consent (ICF)
Exclusion
- Active or positive testing of COVID-19 With Clinical Report and Discharge Summary from Hospital or Treatment Facility
- Lung disorder without prior confirmation by approved test protocol of history of COVID-19
- Patient health or condition deemed dangerous or inappropriate for transport, exceeding acceptable stress for transport or care needed to achieve access to the clinical facility, at the discretion of the Providers
- Expected lifespan of \< 6 months
- Serious of life threatening co-morbidities, that in the opinion of the investigators, may compromise the safety or compliance with the study guidelines and tracking
Key Trial Info
Start Date :
March 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04326036
Start Date
March 25 2020
End Date
January 31 2024
Last Update
February 22 2023
Active Locations (1)
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1
Robert W. Alexander, MD, FICS, LLC
Stevensville, Montana, United States, 59870