Sponsor study identifier
Secondary identifiers
observational
11,363
1 country
3
Study Start
August 26, 2020
Actual (reported)Primary Completion
December 31, 2021
Actual (reported)Study Completion
January 21, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 21, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 3, 2020
Actual (reported)April 6, 2020
Actual (reported)August 26, 2020
Actual (reported)December 31, 2021
Actual (reported)January 21, 2022
Actual (reported)Number of people with detectable antibodies to SARS-COV2 and follow them over one year to evaluate change over a 12 month period
Anti-SARS-COV2 IgG and IgM ELISA
2 years
Healthy Volunteers
Community sample
University of Alabama
Birmingham, Alabama, 35233, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Kalish H, Klumpp-Thomas C, Hunsberger S, Baus HA, Fay MP, Siripong N, Wang J, Hicks J, Mehalko J, Travers J, Drew M, Pauly K, Spathies J, Ngo T, Adusei KM, Karkanitsa M, Croker JA, Li Y, Graubard BI, Czajkowski L, Belliveau O, Chairez C, Snead K, Frank P, Shunmugavel A, Han A, Giurgea LT, Rosas LA, Bean R, Athota R, Cervantes-Medina A, Gouzoulis M, Heffelfinger B, Valenti S, Caldararo R, Kolberg MM, Kelly A, Simon R, Shafiq S, Wall V, Reed S, Ford EW, Lokwani R, Denson JP, Messing S, Michael SG, Gillette W, Kimberly RP, Reis SE, Hall MD, Esposito D, Memoli MJ, Sadtler K. Mapping a Pandemic: SARS-CoV-2 Seropositivity in the United States. medRxiv [Preprint]. 2021 Jan 31:2021.01.27.21250570. doi: 10.1101/2021.01.27.21250570.
Matthew J Memoli, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
11,363 participants (actual enrollment reported by the registry).
First Submitted
April 3, 2020
First Posted
April 6, 2020
Study Start
August 26, 2020
Actual (reported)Rapid SARS-CoV-2 IgG Antibody Testing in High Risk Healthcare Workers
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2021
Actual (reported)Study Completion
January 21, 2022
Actual (reported)Last Updated
January 26, 2024
Record last verified: 2024-01
.Data will be shared per existing DUA with RDCRN and study sites. @@@@@@Unidentifiable IPD will also be made public through NCI seronet.
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Source: ClinicalTrials.gov.
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