This study is NOT currently recruiting participants.
Number
20-I-0083
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
None
Keywords
COVID-19; Immunity; Antibodies; Respiratory Virus; Virus; Natural History
Recruitment Keyword(s)
Condition(s)
SARS-COV2 Virus
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Allergy and Infectious Diseases
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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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.
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.
Principal Investigator
Referral Contact
For more information: