Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection

Summary

The purpose of the study is to understand how COVID affects the body and why some individuals who contract COVID are still sick for many months after being infected. This condition is called PASC (post-acute sequelae of SARS-CoV-2), know also as Long COVID. Participants will be 18 years or older and can have a current or history of COVID infection or can be enrolled as controls who have never had a COVID infection. Researchers aim to determine who is at greatest risk of experiencing long-term effects of COVID by studying individuals with and without a history of COVID-19 over several years.

Participants will be asked to answer basic questions (race, ethnic group, sex), in addition to questions about their health, behaviors, medical problems, medications, conditions that may affect the chances of having long-term effects of COVID-19, vaccination status, and any symptoms they may have. Blood, saliva, urine and other samples will also be collected.

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:

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:
Patients who meet the following clinical criteria plus one of the epidemiological criteria:
Clinical Criteria: Acute onset of fever and cough OR acute onset of any three of 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:
Residing or working in an area with a high risk of transmission of virus: closed residential settings, humanitarian settings such as camp and camp-like settings for displaced persons; anytime within the 14 days before symptom onset; or
Residing or travel to an area with community transmission anytime within the 14 days before symptom onset; or
Working in any health care setting, including within health facilities or within the community; anytime within the 14 days before symptom onset.
A patient with severe acute respiratory illness: (acute respiratory infection with history of fever or measured fever of ≥38C°; and cough; with onset within the last 10 days; and requires hospitalization).
An asymptomatic person not meeting epidemiologic criteria with a positive SARS-CoV-2 Antigen-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:
A patient who meets clinical criteria for suspected SARS-CoV-2 AND is a contact of a probable or confirmed case or linked to a COVID-19 cluster;
A suspect case with chest imaging showing findings suggestive of COVID-19 disease;
A person with recent onset of anosmia (loss of smell) or ageusia (loss of taste) in the absence of any other identified cause;
Death, not otherwise explained, in an adult with respiratory distress preceding death AND was a contact of a probable or confirmed case or linked to a COVID-19 cluster
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:
Any person with a positive Nucleic Acid Amplification Test (NAAT);
Any person with a positive SARS-CoV-2 Antigen-RDT OR positive SARS-CoV-2 antibody test* AND meeting either the probable case definition or suspect criteria A OR B;
An asymptomatic person with a positive SARS-CoV-2 Antigen-RDT who is a contact of a probable or confirmed case
Any person with a positive SARS-CoV-2 nucleocapsid protein antibody test OR a positive SARS-CoV-2 spike protein antibody test IF not vaccinated
(*)This protocol modifies the WHO criterion b to add detectable SARS-CoV-2 antibody 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 of SARS-CoV-2 infection, AND
Has a documented negative SARS-CoV-2 PCR test from a respiratory specimen in the past, 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 the time of enrollment/screening, AND
Has a negative SARS-CoV-2 nucleocapsid protein antibody and spike protein antibody test (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 the SARS-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 the long-term impact of COVID on children and families
Incarcerated individuals