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Surveillance of Individuals Following SARS-CoV-2 Exposure

Surveillance of Individuals Following SARS-CoV-2 Exposure

Recruiting
18 years and older
All
Phase N/A

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:

  1. Determine rate of culture positivity in individuals who persistently shed virus.
  2. 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:

  1. SARS-CoV-2 culture and RT-PCR results.
  2. 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).

Study details
    Covid 19

NCT04383444

National Institute of Allergy and Infectious Diseases (NIAID)

19 February 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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