Serological Surveillance for COVID-19 in Central North Carolina

NCT04490174 | Completed

• 2 other identifiers: 20014320-E-0143
• Study Type: observational
• Target: 643
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

COVID-19

Keywords

SARS-CoV-2; Natural History

Outcome Measures

Primary Outcomes (1)

• Anti-SARS-COV-2 antibodies

  Proportion of people with detectable Anti-SARS-COV-2 antibodies

  Day1, months 3, 6, 9, 12

Secondary Outcomes (5)

• 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

• 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

• Clinical questionnaires and ELISA antibody testing results

  Day1, months 3, 6, 9, 12

Study Arms (1)

Healthy participants

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (3)

• 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.

  PMID: 32064853 BACKGROUND

• Tandon 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.

  PMID: 32202260 BACKGROUND

• Dong 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.

  PMID: 32202993 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stavros Garantziotis, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 29, 2020
• Study Start: August 24, 2020
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)