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SARS-COV2 Pandemic Serosurvey and Blood Sampling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334954
Recruitment Status : Completed
First Posted : April 6, 2020
Last Update Posted : July 7, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Description
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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.


Condition or disease
SARS-COV2 Virus

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.
Study Design
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Study Type : Observational
Actual Enrollment : 11363 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: SARS-COV2 Pandemic Serosurvey and Blood Sampling
Actual Study Start Date : August 26, 2020
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : January 21, 2022
Groups and Cohorts
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Group/Cohort
Healthy Volunteers
Healthy Volunteers


Outcome Measures
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Primary Outcome Measures :
  1. Number of people with detectable antibodies to SARS-COV2 and follow them over one year to evaluate change over a 12 month period [ Time Frame: 2 years ]
    Anti-SARS-COV2 IgG and IgM ELISA


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334954


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Matthew J Memoli, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04334954    
Other Study ID Numbers: 200083
20-I-0083
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: May 12, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .Data will be shared per existing DUA with RDCRN and study sites. @@@@@@Unidentifiable IPD will also be made public through NCI seronet.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
COVID-19
Immunity
Antibodies
 Respiratory Virus
Virus
Natural History