Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)

Inclusion Criteria:

INFECTED COHORT -- ADULTS WITH SUSPECTED SARS-COV-2 INFECTION --

An adult qualifies as having suspected SARS-CoV-2 infection if meeting criteria a, b or c below:

1. Patients who meet the following clinical criteria plus one of the epidemiologicalcriteria: Clinical Criteria: Acute onset of fever and cough OR acute onset of any three ofmore 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:

2. Residing or working in an area with a high risk of transmission of virus:closed residential settings, humanitarian settings such as camp and camp-likesettings for displaced persons; anytime within the 14 days before symptomonset; or

3. Residing or travel to an area with community transmission anytime within the 14days before symptom onset; or

4. Working in any health care setting, including within health facilities orwithin the community; anytime within the 14 days before symptom onset.

5. A patient with severe acute respiratory illness: (acute respiratory infection withhistory of fever or measured fever of ≥38C°; and cough; with onset within the last 10 days; and requires hospitalization).

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

ADULTS WITH PROBABLE SARS-COV-2 INFECTION --

An adult qualifies as having probable SARS-CoV-2 infection if meeting any one of a-d below:

1. A patient who meets clinical criteria for suspected SARS-CoV-2 AND is a contact of aprobable or confirmed case or linked to a COVID-19 cluster;

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

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

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

ADULTS WITH CONFIRMED SARS-COV-2 INFECTION --

An adult qualifies as having confirmed SARS-CoV-2 infection if meeting any one of a-d below:

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

2. Any person with a positive SARS-CoV-2 Antigen-RDT OR positive SARS-CoV-2 antibodytest* AND meeting either the probable case definition or suspect criteria A OR B;

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

4. Any person with a positive SARS-CoV-2 nucleocapsid protein antibody test OR apositive SARS-CoV-2 spike protein antibody test IF not vaccinated

• (*)This protocol modifies the WHO criterion b to add detectable SARS-CoV-2antibody as a qualifying test.

UNINFECTED COHORT -- ADULTS WITH NO SARS-COV-2 INFECTION --

• Does not meet WHO criteria for a suspected, probable, or confirmed case ofSARS-CoV-2 infection, AND

• Has a documented negative SARS-CoV-2 PCR test from a respiratory specimen in thepast, if being enrolled as a post-acute control (see XII.H), AND

• Has a documented negative SARS-CoV-2 PCR test from a respiratory specimen at thetime of enrollment/screening, AND

• Has a negative SARS-CoV-2 nucleocapsid protein antibody and spike protein antibodytest (spike only if not vaccinated) at the time of enrollment, AND

• Live in the same communities or recruited from the same sources as those in theSARS-CoV-2 infected cohort, AND

• Note: uninfected individuals may participate independent of their vaccination status

Exclusion Criteria:

• Individuals who have not yet reached the age of majority

• Unable to provide consent

• Individuals in hospice care

• Any serious medical condition which would prevent long-term participation

• Individuals participating in the study NIH RECOVER-Pediatric: Understanding thelong-term impact of COVID on children and families

• Incarcerated individuals