Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)
- Conditions
- SARS-CoV2 Infection
- Registration Number
- NCT05172024
- Lead Sponsor
- NYU Langone Health
- Brief Summary
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.
- Detailed Description
Ambidirectional longitudinal meta-cohort study (combined retrospective and prospective) with nested case-control studies.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 15178
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of candidate PASC symptoms over time Up to 4 Years Incidence of candidate PASC symptoms over time Up to 4 Years
- Secondary Outcome Measures
Name Time Method Incidence of organ injury Up to 4 Years Incidence of clinical disease Up to 4 Years
Trial Locations
- Locations (86)
The Ohio State University - Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center (UPMC)
🇺🇸Pittsburgh, Pennsylvania, United States
Northshore University HealthSystem
🇺🇸Glenview, Illinois, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Metrohealth System
🇺🇸Cleveland, Ohio, United States
Institute for Systems Biology (ISB)
🇺🇸Seattle, Washington, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Memorial Hermann Health System
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Intermountain Medical Center (Intermountain Healthcare)
🇺🇸Salt Lake City, Utah, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
LDS Hospital - Intermountain Healthcare
🇺🇸Salt Lake City, Utah, United States
University of California, San Francisco (UCSF)
🇺🇸San Francisco, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
University of California San Francisco (Pregnancy Cohort)
🇺🇸San Francisco, California, United States
Morehouse School of Medicine (MSM)
🇺🇸Atlanta, Georgia, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Howard University
🇺🇸Washington, District of Columbia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Kaiser Permanente Georgia
🇺🇸Atlanta, Georgia, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
🇺🇸Boston, Massachusetts, United States
Columbia University (Pregnancy)
🇺🇸New York, New York, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Stanford University
🇺🇸Stanford, California, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
NewYork-Presbyterian Hospital
🇺🇸Queens, New York, United States
University of North Dakota
🇺🇸Grand Forks, North Dakota, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Harvard Medical School
🇺🇸Boston, Massachusetts, United States
Prisma Health Upstate
🇺🇸Greenville, South Carolina, United States
Sanford Health
🇺🇸Sioux Falls, South Dakota, United States
ChristianaCare Health System
🇺🇸Newark, Delaware, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
University of Kansas Medical Center (KUMC)
🇺🇸Kansas City, Kansas, United States
Louisiana State University - Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
Utah Valley Regional Medical Center
🇺🇸Provo, Utah, United States
Columbia University
🇺🇸New York, New York, United States
WakeMed Health & Hospitals
🇺🇸Raleigh, North Carolina, United States
MaineHealth
🇺🇸Portland, Maine, United States
Cambridge Health Alliance (CHA)
🇺🇸Cambridge, Massachusetts, United States
Mass General Brigham - Harvard University
🇺🇸Boston, Massachusetts, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Harvard School Of Public Health
🇺🇸Boston, Massachusetts, United States
University Hospitals MacDonald's Women's Hospital
🇺🇸Cleveland, Ohio, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Bateman Horne Center
🇺🇸Salt Lake City, Utah, United States
University of Mississippi Medical Center (UMMC)
🇺🇸Jackson, Mississippi, United States
The MetroHealth System (Pregnancy Cohort)
🇺🇸Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center (OUHSC)
🇺🇸Oklahoma City, Oklahoma, United States
McKay-Dee Hospital
🇺🇸Ogden, Utah, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States
Women & Infants Hospital
🇺🇸Providence, Rhode Island, United States
Providence Regional Medical Center Everett
🇺🇸Everett, Washington, United States
UTMB Health League City Campus Hospital & Clinics
🇺🇸League City, Texas, United States
University of Texas Medical Branch (UTMB) Galveston
🇺🇸Galveston, Texas, United States
Hispanic Alliance for Clinical and Translational Research
🇵🇷San Juan, Puerto Rico
University of Washington
🇺🇸Seattle, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Providence Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Banner University Medical Center (BUMC) - Phoenix
🇺🇸Phoenix, Arizona, United States
University of Alabama at Birmingham (Pregnancy Cohort)
🇺🇸Birmingham, Alabama, United States
University of Colorado Denver
🇺🇸Denver, Colorado, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Denver Health and Hospital Authority
🇺🇸Denver, Colorado, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University Of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Medical College Of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Boston University
🇺🇸Boston, Massachusetts, 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
Louisiana State University (LSU)
🇺🇸New Orleans, Louisiana, United States
St. David's Health Care
🇺🇸Austin, Texas, United States
University of North Carolina (UNC) at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Yale School of Medicine (YSM)
🇺🇸New Haven, Connecticut, United States
University of Hawai'i - Mānoa's John A. Burns School of Medicine
🇺🇸Honolulu, Hawaii, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of New Mexico Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States