Post COVID -19 DepressionPhase 2COVID LongNCT05346120
Post-Acute COVID-19, Inflammation, and Depression
A Phase 2 study testing allogeneic marrow stromal cells (MSCs) in people with Post COVID -19 Depression, run by Sean Savitz.
Trial 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 cells/kg allogeneic marrow stromal cells (MSCs). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post COVID -19 Depression
- What is being tested?
- allogeneic marrow stromal cells (MSCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2022to 1 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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 cells/kg allogeneic marrow stromal cells (MSCs).
Read the 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.
- Conditions
- Post COVID -19 Depression
- Being tested
- allogeneic marrow stromal cells (MSCs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic marrow stromal cells (MSCs)Biological
stem cell infusion
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Single IV infusion of 6 million cells/kg allogeneic marrow stromal cells (MSCs) lasting approximately 30 minutes Receives: Biological: allogeneic marrow stromal cells (MSCs) |
| Placebo controlled | Placebo comparator | PlasmaLyte A supplemented with 5% HSA Receives: Biological: allogeneic marrow stromal cells (MSCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptomatology (QIDS-SR)
depression rating scale
Measured: from pre-infusion to Day 90
Secondary outcomes (1)
PROMIS
Health related quality of life and scales measuring fatigue, pain, anger, anxiety
Measured: from pre-infusion to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start25 May 2022 (estimated)
- Primary completion20 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID -19 DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single site, double blind, placebo-controlled, longitudinal study with a 1:1 ratio randomization
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sean Savitz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sean Savitz, The University of Texas Health Science Center, Houston
- Investigators
- Susan E Alderman, PhD, Study director, UTHealth Science Center Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346120
- Sponsor's protocol ID
- COVID long
- Acronym
- COVID Long
- Status last verified
- Dec 2023
- First submitted
- 24 Apr 2022
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Acute COVID-19, Inflammation, and Depression
- ClinicalTrials.gov ID
- NCT05346120
- Acronym / sponsor ID
- COVID Long / COVID long
- Conditions
- Post COVID -19 Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sean SavitzUniversity, hospital or other
- Study start
- 25 May 2022 (estimated)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 cells/kg allogeneic marrow stromal cells (MSCs).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single site, double blind, placebo-controlled, longitudinal study with a 1:1 ratio randomization
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: allogeneic marrow stromal cells (MSCs)Single IV infusion of 6 million cells/kg allogeneic marrow stromal cells (MSCs) lasting approximately 30 minutes |
| Placebo controlled | Placebo comparator | Biological: allogeneic marrow stromal cells (MSCs)PlasmaLyte A supplemented with 5% HSA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic marrow stromal cells (MSCs)stem cell infusion | Biological | Intervention, Placebo controlled |
Primary outcome
Quick Inventory of Depressive Symptomatology (QIDS-SR)
Time frame: from pre-infusion to Day 90
depression rating scale
1 secondary outcome
PROMIS
Time frame: from pre-infusion to Day 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan E Alderman, PhD study director
UTHealth Science Center Houston
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing allogeneic marrow stromal cells (MSCs) in people with Post COVID -19 Depression, run by Sean Savitz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Inventory of Depressive Symptomatology (QIDS-SR) (time frame: from pre-infusion to Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.