STUDY TO EVALUATE THE ROLE OF T CELL-DYSFUNCTION IN SYMPTOMS ASSOCIATED WITH LONG COVID, LYME DISEASE AND MYALGIC ENCEPHALOMYELITIS/CHRONIC FATIGUE SYNDROME USING THE VIRAXIMMUNE FLUOROSPOT T CELL ASSAY
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Performance of the ViraxImmune FluoroSpot T cell assay (PPA / NPA - predicted outcome)
研究概览
简要总结
This is a longitudinal observational study recruiting individuals that have attended three clinical sites with symptoms associated with a diagnosis of long COVID, PTLDS or ME/CFS. The study will be a multi-centre study, with up to 160 male and female participants enrolled. Participants that experience symptoms considered to be associated with a diagnosis of long COVID, PTLDS or ME/CFS will consent to the study, and attend for two study visits (at study entry and 6 months) to complete a questionnaire related to their symptoms, and to have a blood sample taken. Blood samples will be taken either at the clinical site or at the participant's home if they are unable to attend due to the severity of their illness. . Participants will be allocated to one of the following groups:
Group 1: Long COVID Group 2: ME/CFS Group 3: PTLDS Group 4: Healthy Control
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or older
- •History of acute COVID-19 infection (medically recorded)
- •Symptoms of fatigue and, shortness of breath and/or, joint pain and/or, problems with memory and concentration which have been present for more than a period of 6 months post infection
- •Nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac, aspirin, etc.) must have been stopped at least 48 hours prior to admission to the clinical research centre (evaluation through questionnaire).
- •Willing and able to sign the ICF and comply with study procedures.
排除标准
- •Taking immunosuppressive medication (including corticosteroids), or receiving chemotherapy, cytokine or anti-cytokine therapy, or antithrombotic medication (evaluation through questionnaire).
- •Significant and/or acute illness within 5 days prior to admission that may impact safety assessments, in the opinion of the Investigator.
- •Participants who are, in the opinion of the Investigator, not suitable for enrolment for another reason. For example, participants with: cognitive impairment or severe mental health conditions that might affect their ability to provide informed consent or follow study procedures; non-adherence risk where participants are unlikely to follow study protocols; participants with other chronic inflammatory conditions not under investigation e.g. inflammatory bowel disease, COPD that may have immune profiles that differ from the study's intended populationI
结局指标
主要结局
Performance of the ViraxImmune FluoroSpot T cell assay (PPA / NPA - predicted outcome)
时间窗: 18 months
To evaluate the performance of the ViraxImmune FluoroSpot T cell assay to identify T cell dysfunction in participants diagnosed with long COVID, post treatment Lyme disease (PTLD) and Myalgic Encephalomyelitis/Chronic Fatigue (ME/CFS)
次要结局
未报告次要终点