NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Surveillance of Individuals Following SARS-CoV-2 infection

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-I-0117

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

COVID-19;
Coronavirus;
Antibody Testing;
Severe Acute Respiratory Syndrome-Coronavirus-2 infection;
Natural History

Recruitment Keyword(s)

None

Condition(s)

COVID-19

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

Background:

People who have had contact with a person with a known SARS-CoV-2 infection are being told to self-quarantine for 14 days. This is done to avoid potential virus spread. But the actual time it takes for a person to develop an infection after being exposed to the virus is not well known. The proper quarantine time could be less or more than 2 weeks. Researchers hope this study can be used to help improve public health guidelines for quarantines, social distancing, and returning to work after a possible SARS-CoV-2 exposure.

Objective:

To better understand how long it takes a person to develop (or not develop) an infection with the SARS-CoV-2 virus after they have had contact with a person who has a confirmed infection.

Eligibility:

NIH staff members age 18 and older who had recent contact with a person who has a SARS-CoV-2 infection

Design:

Participants will have 3 study visits at the NIH Clinical Center. They may be asked to have an extra visit depending on the test results at the third visit.

At each visit, participants will give a blood and saliva sample. It will be used to test for SARS-CoV-2 antibodies. Their temperature will be taken. They will complete a short survey to collect data about possible COVID-19 symptoms. At the first visit only, they will also complete a survey that asks about their recent social contacts.

Two types of nasal samples will be collected at each visit. These samples will be tested for the SARS-CoV-2 virus.

1. a swab will be inserted deep into the back of the nose and

2. a swab will be inserted to the middle of your nose.

Participation lasts 3 to 4 weeks.

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Eligibility

INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. Able to attent study visits at the NIH.

2. Age greater than or equal to 18 years.

3. Meets one of the following case definitions:

a. Confirmed case: At lease one current or recent (within past 14 days positive RT-PCR test for SARS-CoV-2.

b.Probable case: Suspected current or recent (within the past 14 days) SARS-CoV-2 infection by referring physician but no availability of confirmatory test results.

4. Able to provide informed consent.

5. Willing to allow storage of samples for future research..

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. The most recent RT-PCR tests have yielded two negatives.

2. Inability or unwillingness to have NP sampling, mid-turbinate, or saliva sampling

3. Inability or unwillingness to have blood sampling.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Steven M. Holland, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 11N248A
10 CENTER DR
BETHESDA MD 20892
(301) 402-7684
sholland@mail.nih.gov

Lisa A. Barnhart, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 11N234
10 Center Drive
Bethesda, Maryland 20892
(301) 496-5270
lbarnhart@niaid.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04383444

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NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Surveillance of Individuals Following SARS-CoV-2 infection

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-I-0117

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

COVID-19;
Coronavirus;
Antibody Testing;
Severe Acute Respiratory Syndrome-Coronavirus-2 infection;
Natural History

Recruitment Keyword(s)

None

Condition(s)

COVID-19

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

Background:

People who have had contact with a person with a known SARS-CoV-2 infection are being told to self-quarantine for 14 days. This is done to avoid potential virus spread. But the actual time it takes for a person to develop an infection after being exposed to the virus is not well known. The proper quarantine time could be less or more than 2 weeks. Researchers hope this study can be used to help improve public health guidelines for quarantines, social distancing, and returning to work after a possible SARS-CoV-2 exposure.

Objective:

To better understand how long it takes a person to develop (or not develop) an infection with the SARS-CoV-2 virus after they have had contact with a person who has a confirmed infection.

Eligibility:

NIH staff members age 18 and older who had recent contact with a person who has a SARS-CoV-2 infection

Design:

Participants will have 3 study visits at the NIH Clinical Center. They may be asked to have an extra visit depending on the test results at the third visit.

At each visit, participants will give a blood and saliva sample. It will be used to test for SARS-CoV-2 antibodies. Their temperature will be taken. They will complete a short survey to collect data about possible COVID-19 symptoms. At the first visit only, they will also complete a survey that asks about their recent social contacts.

Two types of nasal samples will be collected at each visit. These samples will be tested for the SARS-CoV-2 virus.

1. a swab will be inserted deep into the back of the nose and

2. a swab will be inserted to the middle of your nose.

Participation lasts 3 to 4 weeks.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. Able to attent study visits at the NIH.

2. Age greater than or equal to 18 years.

3. Meets one of the following case definitions:

a. Confirmed case: At lease one current or recent (within past 14 days positive RT-PCR test for SARS-CoV-2.

b.Probable case: Suspected current or recent (within the past 14 days) SARS-CoV-2 infection by referring physician but no availability of confirmatory test results.

4. Able to provide informed consent.

5. Willing to allow storage of samples for future research..

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. The most recent RT-PCR tests have yielded two negatives.

2. Inability or unwillingness to have NP sampling, mid-turbinate, or saliva sampling

3. Inability or unwillingness to have blood sampling.


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Steven M. Holland, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 11N248A
10 CENTER DR
BETHESDA MD 20892
(301) 402-7684
sholland@mail.nih.gov

Lisa A. Barnhart, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 11N234
10 Center Drive
Bethesda, Maryland 20892
(301) 496-5270
lbarnhart@niaid.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04383444

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