SARS-COV2 Pandemic Serosurvey and Blood Sampling

NCT04334954 | Completed

• 2 other identifiers: 20008320-I-0083
• Study Type: observational
• Target: 11,363
• Locations: 1 country
• Sites: 3

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.

Conditions

SARS-COV2 Virus

Keywords

COVID-19; Immunity; Antibodies; Respiratory Virus; Virus; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy Volunteers

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• \>= 18 years of age.
• Willing and able to complete a verbal telephone consent.
• Willing to undergo one blood draw or home blood sampling.
• Willing to have blood samples stored for future research.
• Co-enrollment Guidelines
• Participants may be co-enrolled in other research studies.

You may not qualify if:

• Current symptoms consistent with COVID19 infection
• Any condition or event that, in the PI s opinion, may substantially increase the risk associated with study participation or compromise the study's scientific objectives. Conditions that exclude a subject are considered to be unlikely, but an example would include having a blood clotting disorder that would make it unsafe to obtain blood samples.
• Not willing to have blood samples stored for future research.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

• 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.

  PMID: 33532807 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19; Virus Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Matthew J Memoli, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 6, 2020
• Study Start: August 26, 2020
• Primary Completion: December 31, 2021
• Study Completion: January 21, 2022
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD will be shared starting a maximum of 1 year after publication.
• Access Criteria: The IPD will be available publicly.

Locations

US (3)