Overview
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.
ObjectiveTo 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.
EligibilityNIH staff members age 18 and older who had recent contact with a person who has a SARS-CoV-2 infection
DesignParticipants 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.
ObjectivesPrimary 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).
Eligibility
- INCLUSION CRITERIA:
To be eligible to participate in this study, an individual must meet all of the following
criteria- Works at an NIH facility and is able to come to the NIH campus for study visits.
- Age greater than or equal to 18 years.
- Meets one or both of the following:
- Current or previous SARS-CoV-2 infection (either clinical or laboratory based) but currently asymptomatic.
- History of SARS-CoV-2 risk exposure, defined as one of the following:
- Is or has been on the NIH OMS-qualified SARS-CoV-2/COVID-19 contact list.
ii. Has had contact at home or in the workplace with a person with known or suspected SARS-CoV-2 infection.
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:
- Inability or unwillingness to have NP sampling.
- Inability or unwillingness to have blood sampling.
- Exhibiting any of the following COVID-19 symptoms within the previous 48 hours:
- Fever or chills (shaking chills)
- Sore throat
- Cough
- Difficulty breathing
- Loss of taste
- Loss of smell