Serological Surveillance for COVID-19 in Central North Carolina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 643
- 试验地点
- 2
- 主要终点
- Anti-SARS-COV-2 antibodies
研究概览
简要总结
Background:
The SARS-CoV-2 virus has caused a pandemic. Little is known about the virus, so data is needed to form an effective public health response. Researchers want to count how many people have been exposed to COVID-19, learn about symptoms, and find out how many antibodies to the SARS-CoV-2 virus a person may have in their blood over 1 year. This data could affect the response to current and future pandemics.
Objective:
To learn how many people from a sampling of adults in North Carolina develop antibodies to the SARS-CoV-2 virus over 1 year.
Eligibility:
Healthy people age 18 and older who do not currently have COVID-19
Design:
Participants will be screened with questions about their health.
Participants will have five 30-minute visits at the Clinical Research Unit. At each visit, they will have blood drawn to see if they have SARS-CoV-2 antibodies.
If the test result is positive for antibodies, the participant will be tested to see if they currently have COVID-19. For this, a nasal or throat swab will be done, or saliva will be collected. They may do this test at the same visit as the blood draw, or they may schedule an extra visit.
Around the time of their study visits, participants will take an online survey about themselves, their health, and COVID-19. It takes 10 minutes to complete. Every week for 52 weeks, they will also take a brief online survey about their symptoms. It takes 2 minutes to complete. They will be emailed a link to log in and fill out the surveys on a secure website.
Participation will last for 1 year.
详细描述
It has been demonstrated that respiratory virus outbreaks and pandemics, such as influenza, SARS, MERS, and now the newly emerged SARS-CoV-2 virus, have a major impact on morbidity and mortality worldwide, as well as having devastating global economic and societal impact. During these outbreaks it is critical to gain a rapid understanding of the exposures and immunity in the general population. Identifying exposures can be accomplished through analysis of serum during an outbreak to identify those with specific antibodies to the pathogen.The knowledge of the level of exposures could greatly impact the response to current and future pandemics.
This study is a prospective, longitudinal, observational, single-center, exploratory, natural history study to collect samples and data from individuals to identify the presence and rate of development of anti-SARS-CoV-2 antibodies in North Carolina.
Objectives: Primary Objective:
To characterize the proportion of people with detectable antibodies to SARS-CoV-2 from a sampling of adults in North Carolina.
Exploratory Objectives:
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
- 是
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Male and females
- •greater than or equal to 18 years of age
- •Able to read and speak English
- •Ability to provide informed consent
- •Able to travel to study visits at the NIEHS CRU for required study visits
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Current symptoms consistent with COVID-19 infection at the point of Antibody Visit 1
- •Inability to provide a blood sample
- •Current pregnancy or lactation, by participant verbal confirmation.
- •Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures.
- •Not willing to have blood samples stored for future research
- •Participants who have Limited English Proficiency will be excluded from the study because the informed consent form is only available in English. The study documents (Demographic and Health Assessment Questionnaire, and Weekly Symptom Questionnaire) and FDA Fact Sheets for Tests with Emergency Use Authorization are only available in English.
- •Decisionally impaired adults and prisoners will be excluded due to the inability to complete necessary study procedures. Adults who become prisoners or decisionally impaired while on study will be withdrawn.
- •Pregnant women are excluded due to the need to have participants venture out during the COVID-19 pandemic. Women who become pregnant during the study will be withdrawn.
- •Children will be excluded from enrolling in this study as immunity in children is different than
- •adults and we are focusing on adult immunity and in this trial
研究组 & 干预措施
Healthy participants
Healthy adults without a current active COVID-19 infection or current symptoms consistent with COVID-19 at the first clinic visit
结局指标
主要结局
Anti-SARS-COV-2 antibodies
时间窗: Day1, months 3, 6, 9, 12
Proportion of people with detectable Anti-SARS-COV-2 antibodies
次要结局
- Positive SARS-CoV-2 PCR(Day1, months 3, 6, 9, 12)
- Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm(Day1, months 3, 6, 9, 12)
- Clinical questionnaires and ELISA antibody testing results(Day1, months 3, 6, 9, 12)