Status:
WITHDRAWN
Post-Acute COVID-19, Inflammation, and Depression
Lead Sponsor:
Sean Savitz
Conditions:
Post COVID -19 Depression
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Single site, double blind, placebo-controlled, longitudinal study of depression in Subjects with COVID- 19 long haulers syndrome using a 1:1 ratio randomization for a single IV infusion of 6 million c...
Detailed Description
A prospective study evaluating depression in COVID- 19 long haulers syndrome treated with allogeneic marrow stromal cells. Accruing evidence suggests cognitive and affective dysfunction, depression, a...
Eligibility Criteria
Inclusion
- 1\. The subject, or legally authorized representative, must be able to understand and voluntarily sign an informed consent document 2. Diagnosed with COVID-19 within the last 90 days 3. Age 18 to 80 years 4. QIDS-SR\> 11
Exclusion
- 1\. A pre-COVID-19 history of cognitive dysfunction, or chronic fatigue 2. Exclude Recurrent episodes of depression (allowed: a prior episode but completed medication at least 3 months before enrollment) 3. Any medical or psychiatric condition which could confound study assessments 4. Stroke within the last 3 months 5. Developmental delay 6. Any other condition that the investigator feels would pose a significant hazard to the patient if enrolled 7. Current participation in any interventional research study 8. Unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05346120
Start Date
May 25 2022
End Date
May 1 2024
Last Update
December 13 2023
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