Eligibility

Eligible Ages

Over 18 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

Patients with suspected SARS-CoV-2 infection

1. Patients who meet the clinical and epidemiological criteria listed below:

Clinical criteria: Acute onset of fever and cough or acute onset of ANY THREE OR
MORE of the following signs or symptoms: fever, cough, general weakness/fatigue,
headache, myalgia, sore throat, coryza, dyspnea, anorexia/nausea/vomiting, diarrhea,
altered mental status.

Epidemiological criteria:

1. Having resided or worked in an area with a high risk of transmission of virus:
closed residential, school, or camp settings any time within the 14 days before
symptom onset; or

2. Having resided or traveled to an area with community transmission any time
within the 14 days before symptom onset; or

3. Any known household contact or any member of the household working in any
health care setting, including within health facilities or within the
community, any time within the 14 days before symptom onset.

2. An asymptomatic person not meeting epidemiologic criteria with a positive SARS-CoV-2
Antigen-RDT.

Patients with probable SARS-CoV-2 infection

1. A patient who meets clinical criteria above AND is a contact of a probable or
confirmed case or linked to a COVID-19 cluster; or

2. A suspected case with chest imaging showing findings suggestive of COVID-19 disease;
or

3. A person with recent onset of anosmia (loss of smell) or ageusia (loss of taste) in
the absence of any other identified cause; or

4. Death, not otherwise explained, in an adult with respiratory distress preceding
death AND who was a contact of a probable or confirmed case or linked to a COVID-19
cluster.

Patients with confirmed SARS-CoV-2 infection

1. A person with a positive Nucleic Acid Amplification Test (NAAT); or

2. A person with a positive SARS-CoV-2 Antigen-RDT AND meeting either the probable case
definition or suspected criteria a) or b); or

3. An asymptomatic person with a positive SARS-CoV-2 Antigen-RDT who was a contact of a
probable or confirmed case.

General Eligibility Notes:

1. Decedents with or without history of MIS-A or MIS-C are eligible;

2. Decedents with or without history of SARS-CoV-2 vaccination are eligible;

3. Decedents with recurrent SARS-CoV-2 infections and those with post-vaccination
(breakthrough) infections are eligible;

4. Decedents are eligible without exclusion related to sex, race/ethnicity, geography,
nationality, severity of disease, or underlying health conditions.