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Understanding the Long-term Impact of COVID-19 in Adults

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05172024
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
17,680
Enrollment
86
Locations
42.8
Anticipated Duration (Months)
205.6
Patients Per Site
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Ambidirectional longitudinal meta-cohort study (combined retrospective and prospective) with nested case-control studies.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    17680 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    NIH RECOVER: A Multi-site Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults
    Actual Study Start Date :
    Oct 29, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2025
    Anticipated Study Completion Date :
    May 23, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Participants with SARS-CoV-2 Infection
    Participants without SARS-CoV-2 Infection

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of candidate PASC symptoms over time [Up to 4 Years]

    2. Prevalence of candidate PASC symptoms over time [Up to 4 Years]

    Secondary Outcome Measures

    1. Incidence of organ injury [Up to 4 Years]

    2. Incidence of clinical disease [Up to 4 Years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    4. 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).

    5. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham (Pregnancy Cohort) Birmingham Alabama United States 35294
    2 University of Alabama at Birmingham Birmingham Alabama United States 35294
    3 University of South Alabama Mobile Alabama United States 36688
    4 Banner University Medical Center (BUMC) - Phoenix Phoenix Arizona United States 85006
    5 University of Arizona Tucson Arizona United States 85724
    6 Cedars-Sinai Medical Center Los Angeles California United States 90048
    7 University of California San Francisco (Pregnancy Cohort) San Francisco California United States 94115
    8 University of California, San Francisco (UCSF) San Francisco California United States 94143
    9 Stanford University Stanford California United States 94305
    10 Denver Health and Hospital Authority Denver Colorado United States 80204
    11 University of Colorado Denver Denver Colorado United States 80204
    12 Yale School of Medicine (YSM) New Haven Connecticut United States 06510
    13 ChristianaCare Health System Newark Delaware United States 19718
    14 George Washington University Washington District of Columbia United States 20052
    15 Howard University Washington District of Columbia United States 20059
    16 Kaiser Permanente Georgia Atlanta Georgia United States 30305
    17 Morehouse School of Medicine (MSM) Atlanta Georgia United States 30310
    18 Emory University Atlanta Georgia United States 30322
    19 University of Hawai'i - Mānoa's John A. Burns School of Medicine Honolulu Hawaii United States 96822
    20 University of Illinois at Chicago Chicago Illinois United States 60608
    21 Northwestern University Evanston Illinois United States 60208
    22 Northshore University HealthSystem Glenview Illinois United States 60026
    23 University of Kansas Medical Center (KUMC) Kansas City Kansas United States 66160
    24 University of Kentucky Lexington Kentucky United States 40506
    25 Louisiana State University - Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808
    26 Louisiana State University (LSU) New Orleans Louisiana United States 70112
    27 University Medical Center New Orleans New Orleans Louisiana United States 70112
    28 Ochsner Health System New Orleans Louisiana United States 70115
    29 Tulane University New Orleans Louisiana United States 70118
    30 MaineHealth Portland Maine United States 04101
    31 Tufts Medical Center Boston Massachusetts United States 02111
    32 Mass General Brigham - Harvard University Boston Massachusetts United States 02114
    33 Massachusetts General Hospital Boston Massachusetts United States 02114
    34 Brigham and Women's Hospital Boston Massachusetts United States 02115
    35 Harvard Medical School Boston Massachusetts United States 02115
    36 Harvard School Of Public Health Boston Massachusetts United States 02115
    37 Beth Israel Deaconess Medical Center (BIDMC) Boston Massachusetts United States 02215
    38 Boston University Boston Massachusetts United States 02215
    39 Cambridge Health Alliance (CHA) Cambridge Massachusetts United States 02139
    40 Mayo Clinic Rochester Minnesota United States 55905
    41 University of Mississippi Medical Center (UMMC) Jackson Mississippi United States 39216
    42 University Of Nebraska Medical Center Omaha Nebraska United States 68198
    43 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
    44 University of New Mexico Health Sciences Center Albuquerque New Mexico United States 87102
    45 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    46 Columbia University (Pregnancy) New York New York United States 10032
    47 Columbia University New York New York United States 10032
    48 NewYork-Presbyterian Hospital Queens New York United States 11355
    49 University of North Carolina (UNC) at Chapel Hill Chapel Hill North Carolina United States 27516
    50 Duke University Medical Center Durham North Carolina United States 27710
    51 WakeMed Health & Hospitals Raleigh North Carolina United States 27610
    52 University of North Dakota Grand Forks North Dakota United States 58202
    53 Good Samaritan Hospital Cincinnati Ohio United States 45220
    54 Case Western Reserve University Cleveland Ohio United States 44106
    55 University Hospitals MacDonald's Women's Hospital Cleveland Ohio United States 44106
    56 Metrohealth System Cleveland Ohio United States 44109
    57 The MetroHealth System (Pregnancy Cohort) Cleveland Ohio United States 44109
    58 The Ohio State University - Wexner Medical Center Columbus Ohio United States 43210
    59 Miami Valley Hospital Dayton Ohio United States 45409
    60 University of Oklahoma Health Sciences Center (OUHSC) Oklahoma City Oklahoma United States 73104
    61 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    62 University of Pittsburgh Medical Center (UPMC) Pittsburgh Pennsylvania United States 15213
    63 Women & Infants Hospital Providence Rhode Island United States 02905
    64 Prisma Health Upstate Greenville South Carolina United States 29605
    65 Sanford Health Sioux Falls South Dakota United States 57106
    66 St. David's Health Care Austin Texas United States 78758
    67 University of Texas Medical Branch (UTMB) Galveston Galveston Texas United States 77555
    68 Memorial Hermann Health System Houston Texas United States 77024
    69 University of Texas Health Science Center at Houston Houston Texas United States 77024
    70 UTMB Health League City Campus Hospital & Clinics League City Texas United States 77573
    71 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    72 McKay-Dee Hospital Ogden Utah United States 84403
    73 Utah Valley Regional Medical Center Provo Utah United States 84604
    74 Bateman Horne Center Salt Lake City Utah United States 84102
    75 Intermountain Medical Center (Intermountain Healthcare) Salt Lake City Utah United States 84107
    76 University of Utah Salt Lake City Utah United States 84112
    77 University of Utah Health Salt Lake City Utah United States 84132
    78 LDS Hospital - Intermountain Healthcare Salt Lake City Utah United States 84143
    79 Providence Regional Medical Center Everett Everett Washington United States 98201
    80 University of Washington Seattle Washington United States 98104
    81 Institute for Systems Biology (ISB) Seattle Washington United States 98109
    82 Swedish Medical Center Seattle Washington United States 98109
    83 Providence Sacred Heart Medical Center Spokane Washington United States 99204
    84 West Virginia University Morgantown West Virginia United States 26506
    85 Medical College Of Wisconsin Milwaukee Wisconsin United States 53226
    86 Hispanic Alliance for Clinical and Translational Research San Juan Puerto Rico 00927

    Sponsors and Collaborators

    • NYU Langone Health
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Stuart Katz, MD, MS, NYU Langone Health
    • Principal Investigator: Leora Horwitz, MD, NYU Langone Health
    • Principal Investigator: Andrea Troxel, ScD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT05172024
    Other Study ID Numbers:
    • 21-01226
    First Posted:
    Dec 29, 2021
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    COVID-19

    Study Results

    No Results Posted as of May 20, 2022