©2022 Stanford Medicine
Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)
Recruiting
Trial ID: NCT05172024
Purpose
This is a combined retrospective and prospective, longitudinal, observational meta-cohort of
individuals who will enter the cohort with and without SARS-CoV-2 infection and at varying
stages before and after infection. Individuals with and without SARS-CoV-2 infection and with
or without Post-Acute Sequelae of COVID-19 (PASC) symptoms will be followed to identify risk
factors and occurrence of PASC. This study will be conducted in the United States and
subjects will be recruited through inpatient, outpatient, and community-based settings. Study
data including age, demographics, social determinants of health, medical history, vaccination
history, details of acute SARS-CoV-2 infection, overall health and physical function, and
PASC symptom screen will be reported by subjects or collected from the electronic health
record using a case report form at specified intervals. Biologic specimens will be collected
at specified intervals, with some tests performed in local clinical laboratories and others
performed by centralized research centers or banked in the Biospecimen Repository. Advanced
clinical examinations and radiologic examinations will be performed at local study sites with
cross-site standardization.
Official Title
NIH RECOVER: A Multi-site Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults
Stanford Investigator(s)
Upinder Singh
Stanford Medicine Professor of Infectious Disease and Professor of Medicine (Infectious Diseases & Geographic Medicine) and of Microbiology and Immunology
Eligibility
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 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:
1. 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
2. Residing or travel to an area with community transmission anytime within the 14
days before symptom onset; or
3. Working in any health care setting, including within health facilities or within
the community; anytime within the 14 days before symptom onset.
2. 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).
3. 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:
1. 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;
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) in
the absence of any other identified cause;
4. 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:
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 antibody
test* 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 a
probable or confirmed case
4. 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
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305