Surveillance of Individuals Following SARS-CoV-2 Infection

NCT04383444 | Completed

• 2 other identifiers: 20011720-I-0117
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

1. 1.a swab will be inserted deep into the back of the nose and
2. 2.a swab will be inserted to the middle of your nose.

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Results of SARS-CoV-2 RT- PCR testing, antibody assay, and culture

  Correlate results of SARS-CoV-2 RT-PCR using various sample types, antibody assays, and culture.

  Days 1, 14, then every 2-4 weeks as needed

Secondary Outcomes (2)

• SARS-CoV-2 culture and RT-PCR results

  Days 1, 14, then ever 2-4 weeks as needed

• Symptom checklist and RT-PCR cycle threshold

  Days 1, 14, then every 2-4 weeks as applicable

Study Arms (1)

SARS-CoV-2 exposure

NIH staff exposed to SARS-CoV-2 or current or previous SARS-CoV-2 infection, but currently asymptomatic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NIH staff or contractors working at an NIH facility and able to come to the NIH campus for study visits.

You may qualify if:

• To be eligible to participate in this study, an individual must meet all of the following criteria:
• Able to attent study visits at the NIH.
• Age greater than or equal to 18 years.
• Meets one of the following case definitions:
• Confirmed case: At lease one current or recent (within past 14 days positive RT-PCR test for SARS-CoV-2.
• 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.
• Able to provide informed consent.
• Willing to allow storage of samples for future research..

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• The most recent RT-PCR tests have yielded two negatives.
• Inability or unwillingness to have NP sampling, mid-turbinate, or saliva sampling
• Inability or unwillingness to have blood sampling.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Steven M Holland, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2020
• First Posted: May 12, 2020
• Study Start: July 7, 2020
• Primary Completion: March 1, 2021
• Study Completion: February 10, 2022
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

US (1)