A Study of Immune Responses to the Virus That Causes COVID-19

Inclusion Criteria:

- Age 18 years or older.

- Test result indicating presence of SARS-CoV-2 virus. Sites must have results from
assays that are approved as FDA-emergency use authorized or as standard-of-care by
other applicable regional governing bodies. For timing of testing, please see group
specific criteria below.

- Ability and willingness to provide informed consent.

- Willingness to have clinical research staff come to place of residence or hospital if
needed.

- Willingness to be followed for the planned duration of the study.

- Assessment of understanding: volunteer demonstrates understanding of this study.

- Agreement to allow access to medical records.

- Asymptomatic participants:

- No current symptoms.

- No symptoms consistent with COVID-19 within 2 weeks prior to positive test
according to the clinical judgement of the investigating clinician. Symptoms
include, but are not limited to, fever, headache, sore throat, cough, dyspnea,
rhinorrhea, diarrhea, myalgias, chills, and anosmia. Please refer to
https://www.cdc.gov/coronavirus/2019-ncov/symptomstesting/symptoms.html for the
current list of symptoms consistent with COVID-19.

- Positive SARS-CoV-2 RNA test or antigen test within six days prior to enrollment
(target time) up to 10 days prior to enrollment (upper allowable window).

- Symptomatic (non-hospitalized) participants:

- Onset of mild symptoms consistent with COVID-19 within 6 days prior to enrollment
(target time) up to 14 days prior to enrollment (upper allowable window).
Symptoms of COVID-19 to be determined by the clinical judgement of the
investigating clinician including-- but not limited to-- fever, headache, sore
throat, cough, dyspnea, rhinorrhea, diarrhea myalgias, chills, and anosmia.
Please refer to
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html for the
current list of symptoms consistent with COVID-19.

- Positive SARS-CoV-2 RNA test or antigen test within six days prior to enrollment
(target time) up to 10 days prior to enrollment (upper allowable window).

- Symptomatic (hospitalized) participants

- Participant hospitalized for COVID-19 within 3 days prior to enrollment (note:
there is no timeframe for either symptom onset or timing of SARS-CoV-2 PCR or
antigen testing for hospitalized participants)

Exclusion Criteria:

- Any medical, psychiatric, occupational, or other condition that, in the judgment of
the investigator, would interfere with, or serve as a contraindication to, protocol
adherence or a volunteer's ability to give informed consent.