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临床试验/NCT05131594
NCT05131594Unknown不适用

Immune Response to Post Acute Sequelae of SARSCoV2: A Correlation of Clinical Symptoms and Inflammatory Pathways

Huntington Memorial Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Correlation of symptomatology with inflammatory profiles in patients with Post-Acute Sequelae of SARS-CoV2 (PASC)

研究概览

简要总结

Many people who have had COVID 19 continue to experience symptoms long after they have recovered from the acute infection. This study will examine the clinical symptoms of people with "Long COVID" and measure various markers of inflammation in their blood.

详细描述

Patients who attend the Long Covid Recovery Clinic at Huntington Hospital will be offered participation in the study. After giving written informed consent, their medical history along with a description of clinical symptoms given through an extensive questionnaire will be accessed. Venous blood will be collected as a baseline and then at follow up visits (as dictated by changes in clinical symptomatology) for evaluation of corollary immune parameters. Patients will be followed at a minimum of every 2 months for 2 years.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Enrolled in Huntington Hospital's Long Covid Recovery Clinic
  • Documented previous infection with SARS-CoV2
  • Symptoms suggestive of post-acute sequelae of SARS-CoV2 (including but not limited to chronic fatigue, brain fog, muscle and joint pain, cardiac and pulmonary issues, or other factors related to their acute COVID-19 event)
  • Signed Informed Consent Form

排除标准

  • No documented positive SARS-CoV2 serologies
  • No post-acute sequelae of SARS-CoV2 symptomatology
  • Incarcerated

结局指标

主要结局

Correlation of symptomatology with inflammatory profiles in patients with Post-Acute Sequelae of SARS-CoV2 (PASC)

时间窗: From onset of infection to 24 months

Do patient symptoms correlate with abnormalities in inflammatory profiles?

Identification of immunologic and inflammatory features of PASC based on results of immunologic and inflammatory assays

时间窗: From onset of infection to 24 months

Are there abnormalities in immunologic and inflammatory assays unique to PASC?

Evaluation and delineation of the pathologic pathways and long-term effects of SARS-CoV2 infection

时间窗: From onset of infection to 60 months

What are the pathological pathways and long-term effects of SARS-CoV2?

Identification of risks factor for PASC

时间窗: From onset of infection to 24 months

What are the risk factors for PASC?

Identification of potential sites of therapeutic intervention to ameliorate symptomatology of PASC

时间窗: From onset of infection to 60 months

Are there potential sites of therapeutic intervention to relieve the symptoms of PASC?

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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