Post-Acute COVID-19, Inflammation, and Depression
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 主要终点
- Quick Inventory of Depressive Symptomatology (QIDS-SR)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind for subject and investigator. Only unblinded is the Cellular Therapy Core which manufactures, randomizes and dispenses MSCs
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject, or legally authorized representative, must be able to understand and voluntarily sign an informed consent document
- •Diagnosed with COVID-19 within the last 90 days
- •Age 18 to 80 years
- •QIDS-SR> 11
排除标准
- •A pre-COVID-19 history of cognitive dysfunction, or chronic fatigue
- •Exclude Recurrent episodes of depression (allowed: a prior episode but completed medication at least 3 months before enrollment)
- •Any medical or psychiatric condition which could confound study assessments
- •Stroke within the last 3 months
- •Developmental delay
- •Any other condition that the investigator feels would pose a significant hazard to the patient if enrolled
- •Current participation in any interventional research study
- •Unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation
结局指标
主要结局
Quick Inventory of Depressive Symptomatology (QIDS-SR)
时间窗: from pre-infusion to Day 90
depression rating scale
次要结局
- PROMIS(from pre-infusion to Day 90)
研究者
Sean Savitz
Neurologist
The University of Texas Health Science Center, Houston