Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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. Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures. 4. 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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Healthy participants Healthy adults without a current active COVID-19 infection or current symptoms consistent with COVID-19 at the first clinic visit

Recruiting Locations

NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina 27709
Contact:
Nicole Edwards
984-287-4416
nicole.edwards@nih.gov

More Details

NCT ID
NCT04490174
Status
Recruiting
Sponsor
National Institute of Environmental Health Sciences (NIEHS)

Study Contact

NIEHS Join A Study Recruitment Group
(855) 696-4347
myniehs@nih.gov

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.