SARS-COV2 Pandemic Serosurvey and Blood Sampling
- Conditions
- SARS-COV2 Virus
- Registration Number
- NCT04334954
- Brief Summary
Background:
Respiratory virus outbreaks and pandemics, such as SARS, MERS, and the new SARS-COV2 virus, have major impacts worldwide. Researchers must act quickly to learn about the exposures and immunity in the general population. This can be done by studying people s blood serum to find those with antibodies to the virus. This knowledge can help in current and future pandemics. In this study, researchers want to find people who have anti-SARS-COV2 antibodies but no known exposure or illness.
Objective:
To find the number of people with detectable antibodies to SARS-COV2 from a sampling of adults who have no known exposure or clinical illness.
Eligibility:
Adults ages 18 and older without a confirmed COVID19 infection or current symptoms consistent with COVID19
Design:
Participants will enroll and give consent over the phone. They will be screened over the phone with a health assessment questionnaire. They will be screened for COVID19 using the NIH COVID19 screening questionnaire.
Participants will give a blood sample. They can go to the NIH Clinical Center or do home blood sampling. In-person collection at NIH is preferred.
If participants go to NIH, 2 tubes of blood will be taken.
If participants do home sampling, they will be sent a home sampling kit. The kit contains gauze, an alcohol pad, a lancet, collection devices, and shipping materials. It also contains detailed instructions. They will collect 80ul of blood and mail it to the NIH lab.
Participants may enroll in the study up to 4 times. They cannot enroll within 30 days of previous enrollment.
- Detailed Description
It has been demonstrated that respiratory virus outbreaks and pandemics, such as influenza, SARS, MERS, and now the newly emerged SARS-COV2 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. In this natural history study, we will collect blood from individuals to identify those who have anti-SARS-COV2 antibodies present despite no confirmed disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11363
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of people with detectable antibodies to SARS-COV2 and follow them over one year to evaluate change over a 12 month period 2 years Anti-SARS-COV2 IgG and IgM ELISA
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States