Post-Acute COVID-19, Inflammation, and Depression

NCT05346120 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: COVID long
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 cells/kg allogeneic marrow stromal cells (MSCs).

Conditions

Post COVID -19 Depression

Outcome Measures

Primary Outcomes (1)

• Quick Inventory of Depressive Symptomatology (QIDS-SR)

  depression rating scale

  from pre-infusion to Day 90

Secondary Outcomes (1)

• PROMIS

  from pre-infusion to Day 90

Study Arms (2)

Intervention

EXPERIMENTAL

Single IV infusion of 6 million cells/kg allogeneic marrow stromal cells (MSCs) lasting approximately 30 minutes

Biological: allogeneic marrow stromal cells (MSCs)

Placebo controlled

PLACEBO COMPARATOR

PlasmaLyte A supplemented with 5% HSA

Biological: allogeneic marrow stromal cells (MSCs)

Interventions

allogeneic marrow stromal cells (MSCs) BIOLOGICAL

stem cell infusion

Intervention; Placebo controlled

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Sean Savitz: lead

Study Officials

• Susan E Alderman, PhD

  UTHealth Science Center Houston

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind for subject and investigator. Only unblinded is the Cellular Therapy Core which manufactures, randomizes and dispenses MSCs
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurologist

Model Details: Single site, double blind, placebo-controlled, longitudinal study with a 1:1 ratio randomization

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: April 26, 2022
• Study Start: May 25, 2022
• Primary Completion: December 20, 2023
• Study Completion: May 1, 2024
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share