Surveillance of Individuals Following SARS-CoV-2 Exposure
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- STATUS
- Recruiting
-
- participants needed
- 1050
-
- sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Summary
- 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.
- a swab will be inserted deep into the back of the nose &
- a swab will be inserted to the middle of your nose.
Participation lasts 3 to 4 weeks.
Description
Study Description:
This is a prospective longitudinal cohort study of contacts of individuals with exposure to severe acute respiratory syndromecoronavirus-2 (SARS-CoV-2). The aim is to correlate results of reverse transcriptionpolymerase chain reaction (RT-PCR) using various sample types, assays, and culture. We will perform serial screenings of NIH employees who have had contact with reported, suspected, or known cases. We will also enroll individuals with previous or current infection who are asymptomatic at enrollment. The serial screenings will be done at multiple timepoints over 2 days using (RT-PCR) tests of nasopharyngeal (NP) swabs, saliva samples, midturbinate swabs, antibody assays, and culture.
- Objectives
Primary Objective:
Correlate results of SARS-CoV-2 RT-PCR using various sample types, antibody assays, and culture.
Secondary Objectives:
- Determine rate of culture positivity in individuals who persistently shed virus.
- Determine proportion of individuals who develop asymptomatic infections.
- Endpoints
Primary Endpoint:
Results of SARS-CoV-2 RT-PCR using NP swab, saliva, and midturbinate swab, antibody assay, and culture.
Secondary Endpoint:
- SARS-CoV-2 culture and RT-PCR results.
- Symptom checklist.
Study Population:
We will enroll up to 1,000 (accrual ceiling: 1,050) adult NIH staff members with exposure to SARS-CoV-2, and those with previous or current infections who are asymptomatic at enrollment.
Facilities Enrolling Participants: NIH CC.
Study Duration: 3 years.
Participant Duration: 28 days (with 35 additional extension visits every 2 to 4 weeks until the participant has 2 consecutive negative RT-PCR results).
Details
| Condition | Covid 19 |
|---|---|
| Age | 18-100 years |
| Clinical Study Identifier | NCT04383444 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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