Status:
COMPLETED
Serological Surveillance for COVID-19 in Central North Carolina
Lead Sponsor:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
COVID-19
Eligibility:
All Genders
18-100 years
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 ...
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 world...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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
- EXCLUSION CRITERIA:
- 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 Adults who become prisoners or decisionally impaired while on study will be withdrawn.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 Women who become pregnant during the study will be withdrawn.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
Exclusion
Key Trial Info
Start Date :
August 24 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 5 2023
Estimated Enrollment :
643 Patients enrolled
Trial Details
Trial ID
NCT04490174
Start Date
August 24 2020
End Date
December 5 2023
Last Update
September 12 2025
Active Locations (1)
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1
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States, 27709