This is a combined retrospective and prospective, longitudinal, observational meta-cohortof individuals who will enter the cohort with and without SARS-CoV-2 infection and atvarying stages before and after infection. Individuals with and without SARS-CoV-2infection and with or without Post-Acute Sequelae of COVID-19 (PASC) symptoms will befollowed to identify risk factors and occurrence of PASC. This study will be conducted inthe United States and subjects will be recruited through inpatient, outpatient, andcommunity-based settings. Study data including age, demographics, social determinants ofhealth, medical history, vaccination history, details of acute SARS-CoV-2 infection,overall health and physical function, and PASC symptom screen will be reported bysubjects or collected from the electronic health record using a case report form atspecified intervals. Biologic specimens will be collected at specified intervals, withsome tests performed in local clinical laboratories and others performed by centralizedresearch centers or banked in the Biospecimen Repository. Advanced clinical examinationsand radiologic examinations will be performed at local study sites with cross-sitestandardization.
Ambidirectional longitudinal meta-cohort study (combined retrospective and prospective)
with nested case-control studies.
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
University of Alabama at Birmingham (Pregnancy Cohort)
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
Banner University Medical Center (BUMC) - Phoenix
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California San Francisco (Pregnancy Cohort)
San Francisco, California, United States
University of California, San Francisco (UCSF)
San Francisco, California, United States
Stanford University
Stanford, California, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
University of Colorado Denver
Denver, Colorado, United States
Yale School of Medicine (YSM)
New Haven, Connecticut, United States
ChristianaCare Health System
Newark, Delaware, United States
George Washington University
Washington, District of Columbia, United States
Howard University
Washington, District of Columbia, United States
Kaiser Permanente Georgia
Atlanta, Georgia, United States
Morehouse School of Medicine (MSM)
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
University of Hawai'i - Mānoa's John A. Burns School of Medicine
Honolulu, Hawaii, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
Northshore University HealthSystem
Glenview, Illinois, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Louisiana State University - Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Louisiana State University (LSU)
New Orleans, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Ochsner Health System
New Orleans, Louisiana, United States
Tulane University
New Orleans, Louisiana, United States
MaineHealth
Portland, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Mass General Brigham - Harvard University
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Harvard Medical School
Boston, Massachusetts, United States
Harvard School Of Public Health
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
Boston University
Boston, Massachusetts, United States
Cambridge Health Alliance (CHA)
Cambridge, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center (UMMC)
Jackson, Mississippi, United States
University Of Nebraska Medical Center
Omaha, Nebraska, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University (Pregnancy)
New York, New York, United States
Columbia University
New York, New York, United States
NewYork-Presbyterian Hospital
Queens, New York, United States
University of North Carolina (UNC) at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
WakeMed Health & Hospitals
Raleigh, North Carolina, United States
University of North Dakota
Grand Forks, North Dakota, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
University Hospitals MacDonald's Women's Hospital
Cleveland, Ohio, United States
Metrohealth System
Cleveland, Ohio, United States
The MetroHealth System (Pregnancy Cohort)
Cleveland, Ohio, United States
The Ohio State University - Wexner Medical Center
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
University of Oklahoma Health Sciences Center (OUHSC)
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
Women & Infants Hospital
Providence, Rhode Island, United States
Prisma Health Upstate
Greenville, South Carolina, United States
Sanford Health
Sioux Falls, South Dakota, United States
St. David's Health Care
Austin, Texas, United States
University of Texas Medical Branch (UTMB) Galveston
Galveston, Texas, United States
Memorial Hermann Health System
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
UTMB Health League City Campus Hospital & Clinics
League City, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
McKay-Dee Hospital
Ogden, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
Bateman Horne Center
Salt Lake City, Utah, United States
Intermountain Medical Center (Intermountain Healthcare)
Salt Lake City, Utah, United States
University of Utah
Salt Lake City, Utah, United States
University of Utah Health
Salt Lake City, Utah, United States
LDS Hospital - Intermountain Healthcare
Salt Lake City, Utah, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
University of Washington
Seattle, Washington, United States
Institute for Systems Biology (ISB)
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Providence Sacred Heart Medical Center
Spokane, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States
Hispanic Alliance for Clinical and Translational Research
San Juan, Puerto Rico