SARS-COV2 Pandemic Serosurvey and Blood Sampling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11363 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-26

Study Completion Date

2022-01-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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SARS-COV2 Virus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy Volunteers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. \>= 18 years of age.
2. Willing and able to complete a verbal telephone consent.
3. Willing to undergo one blood draw or home blood sampling.
4. Willing to have blood samples stored for future research.
5. Have previously participated in Phase 1 of this study (inclusion for Phase II only)

Co-enrollment Guidelines

Participants may be co-enrolled in other research studies.

Exclusion Criteria

1. Confirmed history of COVID19 infection or exposure (exclusion for Phase I only)
2. Current symptoms consistent with COVID19 infection
3. 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.
4. Not willing to have blood samples stored for future research.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No