Serological Surveillance for COVID-19 in Central North Carolina
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04490174|
Recruitment Status : Recruiting
First Posted : July 29, 2020
Last Update Posted : October 26, 2020
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.
To learn how many people from a sampling of adults in North Carolina develop antibodies to the SARS-CoV-2 virus over 1 year.
Healthy people age 18 and older who do not currently have COVID-19
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 or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||2500 participants|
|Official Title:||Serological Surveillance for COVID-19 in Central North Carolina|
|Actual Study Start Date :||August 26, 2020|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2022|
Healthy adults without a current active COVID-19 infection or current symptoms consistent with COVID-19 at the first clinic visit
- Anti-SARS-COV-2 antibodies [ Time Frame: Day1, months 3, 6, 9, 12 ]Proportion of people with detectable Anti-SARS-COV-2 antibodies
- Positive SARS-CoV-2 PCR [ Time Frame: Day1, months 3, 6, 9, 12 ]To identify the rate of asymptomatic carriers of SARS-CoV-2 (PCR positive) among participants with detectable antibodies to SARS-CoV-2
- Clinical questionnaires and ELISA antibody testing resu [ Time Frame: Day1, months 3, 6, 9, 12 ]To associate presence or absence of detectable antibodies to SARS-CoV-2 with respiratory symptoms and future diagnosis with COVID-19
- Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm [ Time Frame: Day1, months 3, 6, 9, 12 ]To determine the natural history of antibody titers among the participants who are found to have detectable antibodies
- Clinical questionnaires and ELISA antibody testing results [ Time Frame: Day1, months 3, 6, 9, 12 ]To associate demographic and medical factors with incidence of newly detectable antibodies to SARS-CoV-2
- Detection of Anti-SARS-CoV-2 antibodies by ELISA Assay Algorithm [ Time Frame: Day1, months 3, 6, 9, 12 ]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 learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04490174
|Contact: NIEHS Join A Study Recruitment Group||(855) email@example.com|
|United States, North Carolina|
|NIEHS Clinical Research Unit (CRU)||Recruiting|
|Research Triangle Park, North Carolina, United States, 27709|
|Contact: Nicole Edwards 984-287-4416 firstname.lastname@example.org|
|Principal Investigator:||Stavros Garantziotis, M.D.||National Institute of Environmental Health Sciences (NIEHS)|