Clinical trial NCT05172024: Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)
Official title: NIH RECOVER: A Multi-site Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: SARS-CoV2 Infection
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-12-29
Enrollment: 15178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infected: Individuals at least 18 years of age meet WHO criteria for suspected, probable or confirmed SARS-CoV-2 infection on or after March 1, 2020.

Uninfected: Individuals at least 18 years of age who have never met any of the WHO criteria for suspected, probable or confirmed SARS-CoV-2 infection.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of candidate PASC symptoms over time
timeFrame: Up to 4 Years
measure: Prevalence of candidate PASC symptoms over time
timeFrame: Up to 4 Years
Secondary outcomes:
measure: Incidence of organ injury
timeFrame: Up to 4 Years
measure: Incidence of clinical disease
timeFrame: Up to 4 Years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (Pregnancy Cohort)
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Phoenix
country: United States
facility: Banner University Medical Center (BUMC) - Phoenix
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco (Pregnancy Cohort)
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF)
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine (YSM)
state: Connecticut
city: Newark
country: United States
facility: ChristianaCare Health System
state: Delaware
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Atlanta
country: United States
facility: Kaiser Permanente Georgia
state: Georgia
city: Atlanta
country: United States
facility: Morehouse School of Medicine (MSM)
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Honolulu
country: United States
facility: University of Hawai'i - Mānoa's John A. Burns School of Medicine
state: Hawaii
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Glenview
country: United States
facility: Northshore University HealthSystem
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center (KUMC)
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baton Rouge
country: United States
facility: Louisiana State University - Pennington Biomedical Research Center
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana State University (LSU)
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Portland
country: United States
facility: MaineHealth
state: Maine
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Mass General Brigham - Harvard University
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Harvard Medical School
state: Massachusetts
city: Boston
country: United States
facility: Harvard School Of Public Health
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (BIDMC)
state: Massachusetts
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Cambridge
country: United States
facility: Cambridge Health Alliance (CHA)
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center (UMMC)
state: Mississippi
city: Omaha
country: United States
facility: University Of Nebraska Medical Center
state: Nebraska
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University (Pregnancy)
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Queens
country: United States
facility: NewYork-Presbyterian Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina (UNC) at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Health & Hospitals
state: North Carolina
city: Grand Forks
country: United States
facility: University of North Dakota
state: North Dakota
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals MacDonald's Women's Hospital
state: Ohio
city: Cleveland
country: United States
facility: Metrohealth System
state: Ohio
city: Cleveland
country: United States
facility: The MetroHealth System (Pregnancy Cohort)
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University - Wexner Medical Center
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center (OUHSC)
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC)
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Prisma Health Upstate
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Austin
country: United States
facility: St. David's Health Care
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch (UTMB) Galveston
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Health System
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: League City
country: United States
facility: UTMB Health League City Campus Hospital & Clinics
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Ogden
country: United States
facility: McKay-Dee Hospital
state: Utah
city: Provo
country: United States
facility: Utah Valley Regional Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: Bateman Horne Center
state: Utah
city: Salt Lake City
country: United States
facility: Intermountain Medical Center (Intermountain Healthcare)
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital - Intermountain Healthcare
state: Utah
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Seattle
country: United States
facility: Institute for Systems Biology (ISB)
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Hispanic Alliance for Clinical and Translational Research
Study officials:
affiliation: NYU Langone Health
name: Stuart Katz, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Leora Horwitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Andrea Troxel, ScD
role: PRINCIPAL_INVESTIGATOR
References: