Post-Acute COVID-19, Inflammation, and Depression (COVID Long)
Study Overview
Status
Conditions
Intervention / Treatment
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, and fatigue occur after COVID-19 infection. These impairments, likely arise from multiple factors that may include cell/organ damage due to direct viral infection or inflammatory process. The current proposal hypothesizes that the inflammatory response is a critical mechanism underlying these neuropsychiatric conditions.
After recovery from COVID-19, the hyperimmune activity secondary to tissue damages and endothelial activation may leave post-acute COVID-19 patients vulnerable to the neural consequences of proinflammatory cytokines Heightened inflammation can alert the central nervous system to induce sickness behaviors and elevated risk of depression.
We hypothesize that allogeneic marrow stromal cells (MSCs) will attenuate post-covid inflammation and reduce the resulting neuropsychiatric symptoms.
Aim 1: Evaluate the feasibility and acceptability of recruiting, providing MSC/sham infusions, and following participants to collect biomarker and clinical outcomes.
• MSC's infusions, baseline and follow-up measurements will be feasible and acceptable to participants.
Aim 2: Estimate the probability of demonstrating improvement in depression (i.e. > 30% reduction on the MADRS) among adult patients experiencing post-COVID depression randomized to MSC Infusion versus Sham Infusion. To determine (obtain, evaluate, verify, etc.) …
• MSC Infusion will out-perform Sham Infusion on the proportion of MADRS responders.
Aim 3: Relative to usual care, estimate the differential improvement of MSC-treated participants on cognitive measures and PROMIS (Health-Related Quality of Life; HRQOL) scales (e.g. Fatigue, Pain, Anger, Anxiety, etc.).
• MSC Infusion will out-perform Sham Infusion +on improvements in cognitive function and HRQOL measures.
Aim 4: Estimate the change attributable to MSC treatment on a panel of inflammatory biomarkers relative to usual care.
• Relative to Sham Infusion, MSC Infusion will down-regulate pro-inflammatory processes while upregulating anti-inflammatory processes, and this modulation will be related to improvement in depression, cognitive and PROMIS measures. Relative to Sham Infusion, MSC Infusion will down-regulate pro-inflammatory processes while upregulating anti-inflammatory processes, and this modulation will be related to improvement in depression, cognitive, and PROMIS measures.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Single IV infusion of 6 million cells/kg allogeneic marrow stromal cells (MSCs) lasting approximately 30 minutes
|
stem cell infusion
|
|
Placebo Comparator: Placebo controlled
PlasmaLyte A supplemented with 5% HSA
|
stem cell infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quick Inventory of Depressive Symptomatology (QIDS-SR)
Time Frame: from pre-infusion to Day 90
|
depression rating scale
|
from pre-infusion to Day 90
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PROMIS
Time Frame: from pre-infusion to Day 90
|
Health related quality of life and scales measuring fatigue, pain, anger, anxiety
|
from pre-infusion to Day 90
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Susan E Alderman, PhD, UTHealth Science Center Houston
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVID long
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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