COVID-19NCT04490174
Serological Surveillance for COVID-19 in Central North Carolina
An observational study of COVID-19, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 643 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2020to 5 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults >18 years age without a current active COVID-19 infection or current symptoms consistent with COVID-19 within Central North Carolina.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, 27709
About this study
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.
Read more
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.
Read the 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.
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:
- SARS-CoV-2 PCR of nasal swabs and correlation with serology
- Clinical questionnaire data and correlation with serology and PCR
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Natural History
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Healthy adults without a current active COVID-19 infection or current symptoms consistent with COVID-19 at the first clinic visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-SARS-COV-2 antibodies
Proportion of people with detectable Anti-SARS-COV-2 antibodies
Measured: Day1, months 3, 6, 9, 12
Secondary outcomes (5)
Positive SARS-CoV-2 PCR
To identify the rate of asymptomatic carriers of SARS-CoV-2 (PCR positive) among participants with detectable antibodies to SARS-CoV-2
Measured: Day1, months 3, 6, 9, 12
Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm
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
Measured: Day1, months 3, 6, 9, 12
Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm
To determine the natural history of antibody titers among the participants who are found to have detectable antibodies
Measured: Day1, months 3, 6, 9, 12
Clinical questionnaires and ELISA antibody testing results
To associate presence or absence of detectable antibodies to SARS-CoV-2 with respiratory symptoms and future diagnosis with COVID-19
Measured: Day1, months 3, 6, 9, 12
Clinical questionnaires and ELISA antibody testing results
To associate demographic and medical factors with incidence of newly detectable antibodies to SARS-CoV-2
Measured: Day1, months 3, 6, 9, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start24 Aug 2020
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stavros Garantziotis, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490174
- Sponsor's protocol ID
- 200143
- Other IDs
- 20-E-0143
- Status last verified
- Jan 2026
- First submitted
- 28 Jul 2020
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
PubMed 32064853Tandon PN. COVID-19: Impact on health of people & wealth of nations. Indian J Med Res. 2020 Feb & Mar;151(2 & 3):121-123. doi: 10.4103/ijmr.IJMR_664_20. No abstract available.
PubMed 32202260Dong L, Bouey J. Public Mental Health Crisis during COVID-19 Pandemic, China. Emerg Infect Dis. 2020 Jul;26(7):1616-1618. doi: 10.3201/eid2607.200407. Epub 2020 Jun 21.
PubMed 32202993
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serological Surveillance for COVID-19 in Central North Carolina
- ClinicalTrials.gov ID
- NCT04490174
- Acronym / sponsor ID
- 200143
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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:
- SARS-CoV-2 PCR of nasal swabs and correlation with serology
- Clinical questionnaire data and correlation with serology and PCR
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | –Healthy adults without a current active COVID-19 infection or current symptoms consistent with COVID-19 at the first clinic visit |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults >18 years age without a current active COVID-19 infection or current symptoms consistent with COVID-19 within Central North Carolina.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anti-SARS-COV-2 antibodies
Time frame: Day1, months 3, 6, 9, 12
Proportion of people with detectable Anti-SARS-COV-2 antibodies
5 secondary outcomes
Positive SARS-CoV-2 PCR
Time frame: Day1, months 3, 6, 9, 12
Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm
Time frame: Day1, months 3, 6, 9, 12
Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm
Time frame: Day1, months 3, 6, 9, 12
Clinical questionnaires and ELISA antibody testing results
Time frame: Day1, months 3, 6, 9, 12
Clinical questionnaires and ELISA antibody testing results
Time frame: Day1, months 3, 6, 9, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Background: PubMed 32064853Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
- Background: PubMed 32202260Tandon PN. COVID-19: Impact on health of people & wealth of nations. Indian J Med Res. 2020 Feb & Mar;151(2 & 3):121-123. doi: 10.4103/ijmr.IJMR_664_20. No abstract available.
- Background: PubMed 32202993Dong L, Bouey J. Public Mental Health Crisis during COVID-19 Pandemic, China. Emerg Infect Dis. 2020 Jul;26(7):1616-1618. doi: 10.3201/eid2607.200407. Epub 2020 Jun 21.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Undecided: It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stavros Garantziotis, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-SARS-COV-2 antibodies (time frame: Day1, months 3, 6, 9, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04490174, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.