Cellular Senescence and Its Contribution to COVID-19 Long-Hauler Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Correlation between features of Long-Hauler Syndrome with markers of cellular senescence and SASP factors
研究概览
简要总结
The purpose of this study is to test if senescent cells and their secretome contribute to Long-Hauler Syndrome and if a clinical trial of senolytic drugs, which selectively eliminate senescent cells, should be initiated.
详细描述
Assays for cellular senescence markers, SASP factors, inflammatory mediators, pro-fibrotic factors, and auto-antibodies in blood and urine will be conducted in patients who provide informed consent. Data will be related to subject age, date of COVID-19 infection, severity of that infection, current Long-Hauler Syndrome symptoms), physical examination findings, underlying conditions, and laboratory data. To understand if an association between features of Long-Hauler Syndrome with markers of cellular senescence and SASP factors can be demonstrated, or SASP factors are higher in Long-Hauler Syndrome clinic patients than controls in this pilot study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Longhauler's Cohort -
- •Inclusion Criteria:
- •Ability to give informed consent or LAR.
- •At least 18 years old.
- •Ability of subject or LAR to read and speak the English language.
- •Positive PCR or antibody test within 12 months of initial study visit.
- •Patient of the Long-Hauler Syndrome clinic and differential diagnosis of Long-Hauler Syndrome.
排除标准
- •Any potential participant who refuses medical record review.
- •Pregnant females.
- •Incarcerated individuals.
- •Inability to cooperate or any medical condition that, in the opinion of the investigator, interferes with the evaluation of the study objectives or increases the subject's risk by participating in the study.
- •Control Cohort -
- •Inclusion Criteria:
- •Ability to give informed consent
- •At least 18 years old
- •Ability of subject to read and speak the English language
- •Exclusion Criteria:
- •Known case of COVID-
- •Any potential participant who refuses medical record review.
- •Pregnant females.
- •Incarcerated individuals.
- •Inability to cooperate or any medical condition that interferes with the evaluation of the study objectives or increases the subject's risk by participating in the study.
- •COVID-19 Control Cohort
- •Inclusion Criteria:
- •Ability to give informed consent.
- •At least 18 years old.
- •Ability of subject to read and speak the English language.
- •Known case of COVID-
- •Exclusion Criteria:
- •Known Longhauler's syndrome/Post-COVID
- •Any potential participant who refuses medical record review.
- •Pregnant females.
- •Incarcerated individuals.
- •Inability to cooperate or any medical condition that interferes with the evaluation of the study objectives or increases the subject's risk by participating in the study.
研究组 & 干预措施
Longhauler's Syndrome Cohort
Subject's with longhaulers
Control Cohort
Control cohort will not have had a known case of COVID-19 or Longhauler's syndrome
COVID Control Cohort
Subjects who have had COVID-19 but no known Longhauler's syndrome
结局指标
主要结局
Correlation between features of Long-Hauler Syndrome with markers of cellular senescence and SASP factors
时间窗: 6 months
If a correlation between features of Long-Hauler Syndrome with markers of cellular senescence and SASP factors can be demonstrated, or SASP factors are higher in Long-Hauler Syndrome clinic patients than age- and sex-matched controls (using archived samples) in this pilot study, a protocol will be submitted to the IRB for a trial in Long-Hauler Syndrome patients of senolytic drugs.
次要结局
未报告次要终点
研究者
Ryan T. Hurt, M.D., Ph.D.
Principal Investigator
Mayo Clinic