Long-term Impact of Infection With Novel Coronavirus (LIINC): An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Proportion of participants previously hospitalized.
研究概览
简要总结
LIINC is a study of volunteers who were previously infected with SARS-CoV-2 (also known as novel coronavirus or COVID-19) who have recovered from acute infection. The study is designed to provide a specimen bank of samples with carefully characterized clinical data. LIINC specimens will be used to examine multiple questions involving the virologic, immunologic, and host factors involved in COVID-19, with a focus on understanding variability in the long-term immune response between individuals.
详细描述
LIINC is an observational, prospective study of individuals previously infected with SARS-CoV-2 who have recovered from acute illness. The overall objective of the study is to investigate the clinical consequences of SARS-CoV-2 infection. These include the pre-existence and development of medical conditions, measures of immune activation and inflammation, changes in immunologic function, and variability in host responses. There will be a specific focus on demographic differences including age, gender, and race.
Enrolled volunteers are seen at San Francisco General Hospital at baseline, monthly for 3 months and then every 3 months for up to 2 years. Visits include a detailed interview, saliva collection, and a blood draw. Baseline visits take approximately 90 minutes, and follow up visits take approximately 20-40 minutes. No personal identifiers are used for specimen bank samples.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent, and
- •Age >/= 18 years, and
- •A history of SARS-CoV-2 infection, as evidenced by:
- •Available laboratory documentation of SARS-CoV-2 RNA positivity on a nucleic acid amplification test or by serologic testing when this becomes available, or
- •Reference by the participant to a laboratory test performed on respiratory tract secretions or blood, fingerstick, or saliva test that was reported to the participant to be positive for SARS-CoV-2 or COVID-19 infection,
- •And a period of 21 days or more has elapsed since the first positive test or symptoms preceding the first positive test, whichever is earlier.
排除标准
- •Self-reported or documented chronic anemia with hemoglobin < 9 g/dL. Anemia during a preceding acute illness will not be exclusionary.
- •Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent.
- •Active drug or alcohol use or dependence that, in the opinion of the Principal Investigator, would interfere with adherence to study requirements or to give informed consent.
研究组 & 干预措施
COVID-19 positive, recovered
Individuals with positive test for COVID-19 who have recovered from acute infection (21 days after symptom onset + improvement in symptoms + resolution of fever for 72 hours without fever reducing medicines).
结局指标
主要结局
Proportion of participants previously hospitalized.
时间窗: Baseline visit
The proportion of participants who were previously hospitalized.
Participant sex
时间窗: Baseline visit
The proportion of men and women participating in the baseline visit.
Participant age
时间窗: Baseline visit
The median age of study participants at enrollment.
Participant race/ethnicity
时间窗: Baseline visit
The proportion of participants from each demographic group.
次要结局
- Long COVID Outcomes(4, 8, 12, 16, 20, and 24 months post-COVID.)