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. ...
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:
- To identify the incidence of newly detectable antibodies to SARS-CoV-2 in the recruited
cohort of adults in North Carolina over 12 months after enrollment
- To identify the rate of asymptomatic carriers of SARS-CoV-2 (PCR positive) among
participants with detectable antibodies to SARS-CoV-2
- To associate presence or absence of detectable antibodies to SARS-CoV-2 with respiratory
symptoms and future diagnosis with COVID-19
- To determine the natural history of antibody titers among the participants who are found
to have detectable antibodies
- To associate demographic and medical factors with incidence of newly detectable
antibodies to SARS-CoV-2
Endpoints: Primary Endpoint:
- Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm
Exploratory Endpoints:
1. SARS-CoV-2 PCR of nasal swabs and correlation with serology
2. Clinical questionnaire data and correlation with serology and PCR
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the
following criteria:
1. Male and females
2. greater than or equal to 18 years of age
3. Able to read and speak English
4. Ability to provide informed consent
5. Able to travel to study visits at the NIEHS CRU for required study visits
6. Stated willingness to comply with all study procedures and availability for the
duration of the study
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation
in this study:
1. Current symptoms consistent with COVID-19 infection at the point of Antibody Visit 1
2. Inability to provide a blood sample
3. Current pregnancy or lactation, by participant verbal confirmation.
4. Any condition that, in the investigator's opinion, places the participant at undue
risk for complications associated with required study procedures.
5. 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
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States
Investigator: NIEHS Join A Study Recruitment Group
Contact: 855-696-4347
myniehs@nih.gov
NIEHS Join A Study Recruitment Group
(855) 696-4347
myniehs@nih.gov
Stavros Garantziotis, M.D.
(984) 287-4412
garantziotis@mail.nih.gov
Stavros Garantziotis, M.D., Principal Investigator
National Institute of Environmental Health Sciences (NIEHS)