Observational Study of Immunological and INFLAMmatory BiomarkErs in COVID-19 Naïve and Infected Participants and Severity of Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To identify immunological and inflammatory biomarkers in participants with and without COVID-19 that may predict a participant's potential risk for severity of disease.
研究概览
简要总结
Observational Study of the Association of Immunological and Inflammatory Biomarkers in COVID-19 Naïve and Infected Participants and Severity of Disease. Thirty naive and 30 COVID positive participants will have a blood sample taken after informed consent and be assessed for COVID symptoms according to WHO classification. Participants will be followed monthly for 6 months. At each contact, participants will be assessed for COVID symptoms and progress since the previous visit.
详细描述
This is an observational study of participants who are being or have been tested for COVID-19. Participants with or without COVID-19 will be entered into one of two groups for Stage 1 and one of three groups for Stage 2.
Stage 1:
- Group 1: Participants whose COVID-19 test is negative and who do not have symptoms of COVID-19 disease.
- Group 2: Participants whose COVID-19 test is positive and who have Severe or Critical symptoms of COVID-19 disease.
Stage 2:
- Group 1: Participants whose COVID-19 test is negative and who do not have symptoms of COVID-19 disease.
- Group 2: Participants whose COVID-19 test is positive and who have Mild or Moderate symptoms of COVID-19 disease.
- Group 3: Participants whose COVID-19 test is positive and who have Severe or Critical symptoms of COVID-19 disease.
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
- 否
入选标准
- •Signed informed consent (IC) within 4 days of COVID-19 test.
- •Age 18 or older
- •COVID-19 test
- •Group 1: negative COVID-19 test Group 2: positive COVID-19 test with Severe or Critical symptoms of disease (per WHO Guidance).
排除标准
- •Any autoimmune disease or immune-modulator therapy.
- •Mild or Moderate symptoms of COVID-19 disease (per WHO Guidance).
结局指标
主要结局
To identify immunological and inflammatory biomarkers in participants with and without COVID-19 that may predict a participant's potential risk for severity of disease.
时间窗: 30 days
Correlation of biomarkers at baseline with severity of COVID-19 disease at baseline and on Day 30 according to WHO classification of COVID-19 symptoms
次要结局
- To correlate the biomarkers at baseline with the duration of symptoms up to six months in participants who develop COVID-19.(6 months)