Study Details

Protocol Status: Enrolling
Study Purpose:
Study Design:

Observational cohort study

Study Population:

Approximately 400 volunteers aged 18 or older

Study Size:
Study Duration:

Minimum one visit (1-8 weeks post resolution of COVID-19 OR 2-10 weeks post most recent positive SARS-CoV-2 test, if symptomatic) and optional visits approximately 2 months, 4 months, and 1 year later. Additional follow up visit(s) may be added over time in response to evolving information regarding SARSCoV-2 infection and COVID-19.

15 months (includes enrollment) with possible extension in response to evolving information regarding SARS-CoV-2 infection and COVID-19.

Treatment Regimen:
Primary Objectives:

Primary objective 1:
To identify serologic reactivities that differentiate SARS-CoV-2 infection from
Primary objective 2:
To develop and formally qualify a suite of immunologic assays and reference
reagents that permit detailed interrogations of the immune response to SARSCoV-2 infection in preparation for similar assessments of vaccine-elicited
immune responses and immunotherapeutics.
Primary objective 3:
To measure SARS-CoV-2-specific adaptive immune responses in order to
identify immune markers of COVID-19 disease severity and duration in different
demographic groups (eg, age, gender) and in people with different medical
histories, including pre-existing conditions, new acute or chronic medical
conditions, and concomitant medications.
Primary objective 4:
To characterize presentations of SARS-CoV-2 infection, including the clinical
course of COVID-19, among convalescent individuals.