Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)

December 10, 2025 updated by: NYU Langone Health

NIH RECOVER: A Multi-site Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

15172

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Hispanic Alliance for Clinical and Translational Research
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham (Pregnancy Cohort)
      • Mobile, Alabama, United States, 36688
        • University Of South Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center (BUMC) - Phoenix
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • San Francisco, California, United States, 94143
        • University of California, San Francisco (UCSF)
      • San Francisco, California, United States, 94115
        • University of California San Francisco (Pregnancy Cohort)
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Denver, Colorado, United States, 80204
        • University of Colorado Denver
      • Denver, Colorado, United States, 80204
        • Denver Health and Hospital Authority
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale School of Medicine (YSM)
    • Delaware
      • Newark, Delaware, United States, 19718
        • ChristianaCare Health System
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20052
        • George Washington University
      • Washington D.C., District of Columbia, United States, 20059
        • Howard University
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30305
        • Kaiser Permanente Georgia
      • Atlanta, Georgia, United States, 30310
        • Morehouse School of Medicine (MSM)
    • Hawaii
      • Honolulu, Hawaii, United States, 96822
        • University of Hawai'i - Mānoa's John A. Burns School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60608
        • University of Illinois at Chicago
      • Evanston, Illinois, United States, 60208
        • Northwestern University
      • Glenview, Illinois, United States, 60026
        • NorthShore University HealthSystem
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center (KUMC)
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Louisiana State University - Pennington Biomedical Research Center
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
      • New Orleans, Louisiana, United States, 70118
        • Tulane University
      • New Orleans, Louisiana, United States, 70115
        • Ochsner Health System
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University (LSU)
    • Maine
      • Portland, Maine, United States, 04101
        • MaineHealth
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02215
        • Boston University
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center (BIDMC)
      • Boston, Massachusetts, United States, 02115
        • Harvard Medical School
      • Boston, Massachusetts, United States, 02115
        • Harvard School of Public Health
      • Boston, Massachusetts, United States, 02114
        • Mass General Brigham - Harvard University
      • Cambridge, Massachusetts, United States, 02139
        • Cambridge Health Alliance (CHA)
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center (UMMC)
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peter's University Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Health Sciences Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10032
        • Columbia University (Pregnancy)
      • Queens, New York, United States, 11355
        • NewYork-Presbyterian Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • University of North Carolina (UNC) at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Health & Hospitals
    • North Dakota
      • Grand Forks, North Dakota, United States, 58202
        • University of North Dakota
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44109
        • MetroHealth System
      • Cleveland, Ohio, United States, 44106
        • University Hospitals MacDonald's Women's Hospital
      • Cleveland, Ohio, United States, 44109
        • The MetroHealth System (Pregnancy Cohort)
      • Columbus, Ohio, United States, 43210
        • The Ohio State University - Wexner Medical Center
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center (OUHSC)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center (UPMC)
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women & Infants Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Upstate
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57106
        • Sanford Health
    • Texas
      • Austin, Texas, United States, 78758
        • St. David's Health Care
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch (UTMB) Galveston
      • Houston, Texas, United States, 77024
        • Memorial Hermann Health System
      • Houston, Texas, United States, 77024
        • University of Texas Health Science Center at Houston
      • League City, Texas, United States, 77573
        • UTMB Health League City Campus Hospital & Clinics
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center
      • Salt Lake City, Utah, United States, 84112
        • University of Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health
      • Salt Lake City, Utah, United States, 84102
        • Bateman Horne Center
      • Salt Lake City, Utah, United States, 84107
        • Intermountain Medical Center (Intermountain Healthcare)
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital - Intermountain Healthcare
    • Washington
      • Everett, Washington, United States, 98201
        • Providence Regional Medical Center Everett
      • Seattle, Washington, United States, 98104
        • University of Washington
      • Seattle, Washington, United States, 98109
        • Institute for Systems Biology (ISB)
      • Seattle, Washington, United States, 98109
        • Swedish Medical Center
      • Spokane, Washington, United States, 99204
        • Providence Sacred Heart Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Participants with SARS-CoV-2 Infection
Participants without SARS-CoV-2 Infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of candidate PASC symptoms over time
Time Frame: Up to 4 Years
Up to 4 Years
Prevalence of candidate PASC symptoms over time
Time Frame: Up to 4 Years
Up to 4 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of organ injury
Time Frame: Up to 4 Years
Up to 4 Years
Incidence of clinical disease
Time Frame: Up to 4 Years
Up to 4 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2021

Primary Completion (Actual)

October 31, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

December 27, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Estimated)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-01226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

IPD Sharing Time Frame

Beginning 9 months and no end date.

IPD Sharing Access Criteria

The investigator who proposed to use the data and investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose will have access to the data upon reasonable request. Requests should be directed to RECOVER_CSC@NYULangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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