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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
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

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.


Condition or disease
COVID-19

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.

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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



Primary Outcome Measures :
  1. Anti-SARS-COV-2 antibodies [ Time Frame: Day1, months 3, 6, 9, 12 ]
    Proportion of people with detectable Anti-SARS-COV-2 antibodies


Secondary Outcome Measures :
  1. 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

  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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria
  • 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.


Information from the National Library of Medicine

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


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

Locations
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United States, North Carolina
NIEHS Clinical Research Unit (CRU) Recruiting
Research Triangle Park, North Carolina, United States, 27709
Contact: Nicole Edwards    984-287-4416    nicole.edwards@nih.gov   
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Stavros Garantziotis, M.D. National Institute of Environmental Health Sciences (NIEHS)
Additional Information:
Publications:
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Responsible Party: National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier: NCT04490174    
Other Study ID Numbers: 200143
20-E-0143
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 20, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ):
SARS-CoV-2