Surveillance of Individuals Following SARS-CoV-2 Infection

Study Description: This is a prospective longitudinal cohort study of individuals who have recently tested positive or are highly suspected to be positive for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV- 2) infection. The aim is to correlate results of reverse transcription-polymerase chain reaction (RT-PCR) using various sample types, assays, and culture. We will enroll individuals with at least one recent positive RT-PCR test result (confirmed cases) and individuals whose referring physician highly suspects current or recent SARS-CoV-2 infection but the individual has not had access to testing (probable cases). At baseline, participants will undergo collection of nasopharyngeal (NP) swabs, saliva samples, and midturbinate swabs for SARS-CoV-2 RT-PCR and culture, and blood draw for antibody assay. Subjects enrolled as probable cases who have a positive baseline RT-PCR result and all subjects enrolled as confirmed cases (regardless of baseline result) will be followed with serial screenings until they have 2 consecutive negative RT-PCR test results. 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. Correlate symptoms with culture positivity and RT-PCR cycle threshold. 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 and RT-PCR cycle threshold value. Study Population: We will enroll up to 1,000 (accrual ceiling: 1,050) adults who have had one or more positive RT-PCR test result(s) within the last two weeks (confirmed cases) and those who have not been tested within the last two weeks but meet a high index of clinical suspicion for current or recent SARS-CoV-2 infection (probable cases). Facilities Enrolling Participants: NIH CC. Study Duration: 3 years. Participant Duration: Probable cases who have negative RT-PCR results at baseline will have a single (baseline) visit. Probable cases with positive baseline RT-PCR and all confirmed cases will continue in the