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

NCT05172024 | Completed DMC

• 1 other identifier: 21-01226
• Study Type: observational
• Target: 15,172
• Locations: 2 countries
• Sites: 86

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.

Conditions

SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (2)

• Incidence of candidate PASC symptoms over time

  Up to 4 Years

• Prevalence of candidate PASC symptoms over time

  Up to 4 Years

Secondary Outcomes (2)

• Incidence of organ injury

  Up to 4 Years

• Incidence of clinical disease

  Up to 4 Years

Study Arms (2)

Participants with SARS-CoV-2 Infection

Participants without SARS-CoV-2 Infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (86)

University of Alabama at Birmingham (Pregnancy Cohort)

Birmingham, Alabama, 35294, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of South Alabama

Mobile, Alabama, 36688, United States

Location

Banner University Medical Center (BUMC) - Phoenix

Phoenix, Arizona, 85006, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California San Francisco (Pregnancy Cohort)

San Francisco, California, 94115, United States

Location

University of California, San Francisco (UCSF)

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

University of Colorado Denver

Denver, Colorado, 80204, United States

Location

Yale School of Medicine (YSM)

New Haven, Connecticut, 06510, United States

Location

ChristianaCare Health System

Newark, Delaware, 19718, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Howard University

Washington D.C., District of Columbia, 20059, United States

Location

Kaiser Permanente Georgia

Atlanta, Georgia, 30305, United States

Location

Morehouse School of Medicine (MSM)

Atlanta, Georgia, 30310, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Hawai'i - Mānoa's John A. Burns School of Medicine

Honolulu, Hawaii, 96822, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60608, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Northshore University HealthSystem

Glenview, Illinois, 60026, United States

Location

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, 66160, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Louisiana State University - Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Louisiana State University (LSU)

New Orleans, Louisiana, 70112, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70115, United States

Location

Tulane University

New Orleans, Louisiana, 70118, United States

Location

MaineHealth

Portland, Maine, 04101, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Mass General Brigham - Harvard University

Boston, Massachusetts, 02114, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

Harvard School Of Public Health

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, 02215, United States

Location

Boston University

Boston, Massachusetts, 02215, United States

Location

Cambridge Health Alliance (CHA)

Cambridge, Massachusetts, 02139, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center (UMMC)

Jackson, Mississippi, 39216, United States

Location

University Of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87102, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University (Pregnancy)

New York, New York, 10032, United States

Location

Columbia University

New York, New York, 10032, United States

Location

NewYork-Presbyterian Hospital

Queens, New York, 11355, United States

Location

University of North Carolina (UNC) at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States

Location

University of North Dakota

Grand Forks, North Dakota, 58202, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University Hospitals MacDonald's Women's Hospital

Cleveland, Ohio, 44106, United States

Location

Metrohealth System

Cleveland, Ohio, 44109, United States

Location

The MetroHealth System (Pregnancy Cohort)

Cleveland, Ohio, 44109, United States

Location

The Ohio State University - Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

University of Oklahoma Health Sciences Center (OUHSC)

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Prisma Health Upstate

Greenville, South Carolina, 29605, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57106, United States

Location

St. David's Health Care

Austin, Texas, 78758, United States

Location

University of Texas Medical Branch (UTMB) Galveston

Galveston, Texas, 77555, United States

Location

Memorial Hermann Health System

Houston, Texas, 77024, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77024, United States

Location

UTMB Health League City Campus Hospital & Clinics

League City, Texas, 77573, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

McKay-Dee Hospital

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center

Provo, Utah, 84604, United States

Location

Bateman Horne Center

Salt Lake City, Utah, 84102, United States

Location

Intermountain Medical Center (Intermountain Healthcare)

Salt Lake City, Utah, 84107, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Utah Health

Salt Lake City, Utah, 84132, United States

Location

LDS Hospital - Intermountain Healthcare

Salt Lake City, Utah, 84143, United States

Location

Providence Regional Medical Center Everett

Everett, Washington, 98201, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Institute for Systems Biology (ISB)

Seattle, Washington, 98109, United States

Location

Swedish Medical Center

Seattle, Washington, 98109, United States

Location

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Hispanic Alliance for Clinical and Translational Research

San Juan, 00927, Puerto Rico

Location

Related Publications (5)

• Kulik GL, Zheng T, Jolley SE, Ashktorab H, Brim H, Feuerriegel EM, Hafner JW, Hess R, Horne BD, Hornig M, Johnson B, Kim C, Laiyemo AO, McComsey GA, Nikolich JZ, Reid K, Scherry J, Sherif ZA, Tran HG, Verduzco-Gutierrez M, West S, Erlandson KM; RECOVER Adult Cohort Consortium. Physical Function Differences by COVID-19 Status: A Cross-sectional Analysis From the RECOVER Adult Cohort. Phys Ther. 2025 Jul 1;105(7):pzaf063. doi: 10.1093/ptj/pzaf063.

  PMID: 40302048 DERIVED

• Erlandson KM, Geng LN, Selvaggi CA, Thaweethai T, Chen P, Erdmann NB, Goldman JD, Henrich TJ, Hornig M, Karlson EW, Katz SD, Kim C, Cribbs SK, Laiyemo AO, Letts R, Lin JY, Marathe J, Parthasarathy S, Patterson TF, Taylor BD, Duffy ER, Haack M, Julg B, Maranga G, Hernandez C, Singer NG, Han J, Pemu P, Brim H, Ashktorab H, Charney AW, Wisnivesky J, Lin JJ, Chu HY, Go M, Singh U, Levitan EB, Goepfert PA, Nikolich JZ, Hsu H, Peluso MJ, Kelly JD, Okumura MJ, Flaherman VJ, Quigley JG, Krishnan JA, Scholand MB, Hess R, Metz TD, Costantine MM, Rouse DJ, Taylor BS, Goldberg MP, Marshall GD, Wood J, Warren D, Horwitz L, Foulkes AS, McComsey GA; RECOVER-Adult Cohort. Differentiation of Prior SARS-CoV-2 Infection and Postacute Sequelae by Standard Clinical Laboratory Measurements in the RECOVER Cohort. Ann Intern Med. 2024 Sep;177(9):1209-1221. doi: 10.7326/M24-0737. Epub 2024 Aug 13.

  PMID: 39133923 DERIVED

• Metz TD, Reeder HT, Clifton RG, Flaherman V, Aragon LV, Baucom LC, Beamon CJ, Braverman A, Brown J, Cao T, Chang A, Costantine MM, Dionne JA, Gibson KS, Gross RS, Guerreros E, Habli M, Hadlock J, Han J, Hess R, Hillier L, Hoffman MC, Hoffman MK, Hughes BL, Jia X, Kale M, Katz SD, Laleau V, Mallett G, Mehari A, Mendez-Figueroa H, McComsey GA, Monteiro J, Monzon V, Okumura MJ, Pant D, Pacheco LD, Palatnik A, Palomares KTS, Parry S, Pettker CM, Plunkett BA, Poppas A, Ramsey P, Reddy UM, Rouse DJ, Saade GR, Sandoval GJ, Sciurba F, Simhan HN, Skupski DW, Sowles A, Thorp JM Jr, Tita ATN, Wiegand S, Weiner SJ, Yee LM, Horwitz LI, Foulkes AS, Jacoby V; NIH Researching COVID to Enhance Recovery (RECOVER) Consortium*. Post-Acute Sequelae of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) After Infection During Pregnancy. Obstet Gynecol. 2024 Sep 1;144(3):411-420. doi: 10.1097/AOG.0000000000005670. Epub 2024 Jul 11.

  PMID: 38991216 DERIVED

• Horwitz LI, Thaweethai T, Brosnahan SB, Cicek MS, Fitzgerald ML, Goldman JD, Hess R, Hodder SL, Jacoby VL, Jordan MR, Krishnan JA, Laiyemo AO, Metz TD, Nichols L, Patzer RE, Sekar A, Singer NG, Stiles LE, Taylor BS, Ahmed S, Algren HA, Anglin K, Aponte-Soto L, Ashktorab H, Bassett IV, Bedi B, Bhadelia N, Bime C, Bind MC, Black LJ, Blomkalns AL, Brim H, Castro M, Chan J, Charney AW, Chen BK, Chen LQ, Chen P, Chestek D, Chibnik LB, Chow DC, Chu HY, Clifton RG, Collins S, Costantine MM, Cribbs SK, Deeks SG, Dickinson JD, Donohue SE, Durstenfeld MS, Emery IF, Erlandson KM, Facelli JC, Farah-Abraham R, Finn AV, Fischer MS, Flaherman VJ, Fleurimont J, Fonseca V, Gallagher EJ, Gander JC, Gennaro ML, Gibson KS, Go M, Goodman SN, Granger JP, Greenway FL, Hafner JW, Han JE, Harkins MS, Hauser KSP, Heath JR, Hernandez CR, Ho O, Hoffman MK, Hoover SE, Horowitz CR, Hsu H, Hsue PY, Hughes BL, Jagannathan P, James JA, John J, Jolley S, Judd SE, Juskowich JJ, Kanjilal DG, Karlson EW, Katz SD, Kelly JD, Kelly SW, Kim AY, Kirwan JP, Knox KS, Kumar A, Lamendola-Essel MF, Lanca M, Lee-Lannotti JK, Lefebvre RC, Levy BD, Lin JY, Logarbo BP Jr, Logue JK, Longo MT, Luciano CA, Lutrick K, Malakooti SK, Mallett G, Maranga G, Marathe JG, Marconi VC, Marshall GD, Martin CF, Martin JN, May HT, McComsey GA, McDonald D, Mendez-Figueroa H, Miele L, Mittleman MA, Mohandas S, Mouchati C, Mullington JM, Nadkarni GN, Nahin ER, Neuman RB, Newman LT, Nguyen A, Nikolich JZ, Ofotokun I, Ogbogu PU, Palatnik A, Palomares KTS, Parimon T, Parry S, Parthasarathy S, Patterson TF, Pearman A, Peluso MJ, Pemu P, Pettker CM, Plunkett BA, Pogreba-Brown K, Poppas A, Porterfield JZ, Quigley JG, Quinn DK, Raissy H, Rebello CJ, Reddy UM, Reece R, Reeder HT, Rischard FP, Rosas JM, Rosen CJ, Rouphael NG, Rouse DJ, Ruff AM, Saint Jean C, Sandoval GJ, Santana JL, Schlater SM, Sciurba FC, Selvaggi C, Seshadri S, Sesso HD, Shah DP, Shemesh E, Sherif ZA, Shinnick DJ, Simhan HN, Singh U, Sowles A, Subbian V, Sun J, Suthar MS, Teunis LJ, Thorp JM Jr, Ticotsky A, Tita ATN, Tragus R, Tuttle KR, Urdaneta AE, Utz PJ, VanWagoner TM, Vasey A, Vernon SD, Vidal C, Walker T, Ward HD, Warren DE, Weeks RM, Weiner SJ, Weyer JC, Wheeler JL, Whiteheart SW, Wiley Z, Williams NJ, Wisnivesky JP, Wood JC, Yee LM, Young NM, Zisis SN, Foulkes AS. Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design. PLoS One. 2023 Jun 23;18(6):e0286297. doi: 10.1371/journal.pone.0286297. eCollection 2023.

  PMID: 37352211 DERIVED

• Metz TD, Clifton RG, Gallagher R, Gross RS, Horwitz LI, Jacoby VL, Martin-Herz SP, Peralta-Carcelen M, Reeder HT, Beamon CJ, Bind MA, Chan J, Chang AA, Chibnik LB, Costantine MM, Fitzgerald ML, Foulkes AS, Gibson KS, Guthe N, Habli M, Hackney DN, Hoffman MK, Hoffman MC, Hughes BL, Katz SD, Laleau V, Mallett G, Mendez-Figueroa H, Monzon V, Palatnik A, Palomares KTS, Parry S, Peralta-Carcelen M, Pettker CM, Plunkett BA, Poppas A, Reddy UM, Rouse DJ, Saade GR, Sandoval GJ, Schlater SM, Sciurba FC, Simhan HN, Skupski DW, Sowles A, Thaweethai T, Thomas GL, Thorp JM Jr, Tita AT, Weiner SJ, Weigand S, Yee LM, Flaherman VJ. Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design. medRxiv [Preprint]. 2023 Apr 24:2023.04.24.23289025. doi: 10.1101/2023.04.24.23289025.

  PMID: 37162923 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Nasal swabs in freeze medium, blood, saliva, stool and urine. For patients undergoing Tier 3 invasive testing through additional consent, or undergoing additional tests as part of routine clinical care, residual samples collected for clinical purposes will whenever possible be collected and sent to the biospecimen core, including: cerebrospinal fluid (CSF), biopsy specimens, bronchoalveolar lavage (BAL), lymph node aspirants

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stuart Katz, MD, MS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Leora Horwitz, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Andrea Troxel, ScD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: December 29, 2021
• Study Start: October 29, 2021
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 9 months and no end date.
• 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.

Locations

US (85); PR (1)