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SARS-CoV2 InfectionNCT05172024

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

An observational study of SARS-CoV2 Infection, run by NYU Langone Health at 86 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-CoV2 Infection
How many people
15,172 participants
Where
86 sitesin 2 countries
Study dates
29 Oct 2021to 31 Oct 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 30Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

86 sites in 2 countries.

86 sites in 2 countries

United States85 sites

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87102

  • Kaiser Permanente Georgia

    Atlanta, Georgia, 30305

  • Morehouse School of Medicine (MSM)

    Atlanta, Georgia, 30310

  • Emory University

    Atlanta, Georgia, 30322

  • St. David's Health Care

    Austin, Texas, 78758

  • Louisiana State University - Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • University of Alabama at Birmingham (Pregnancy Cohort)

    Birmingham, Alabama, 35294

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Mass General Brigham - Harvard University

    Boston, Massachusetts, 02114

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Harvard Medical School

    Boston, Massachusetts, 02115

  • Harvard School Of Public Health

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02215

  • Boston University

    Boston, Massachusetts, 02215

  • Cambridge Health Alliance (CHA)

    Cambridge, Massachusetts, 02139

  • University of North Carolina (UNC) at Chapel Hill

    Chapel Hill, North Carolina, 27516

  • University of Illinois at Chicago

    Chicago, Illinois, 60608

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • University Hospitals MacDonald's Women's Hospital

    Cleveland, Ohio, 44106

  • Metrohealth System

    Cleveland, Ohio, 44109

  • The MetroHealth System (Pregnancy Cohort)

    Cleveland, Ohio, 44109

  • The Ohio State University - Wexner Medical Center

    Columbus, Ohio, 43210

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204

  • University of Colorado Denver

    Denver, Colorado, 80204

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Northwestern University

    Evanston, Illinois, 60208

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201

  • University of Texas Medical Branch (UTMB) Galveston

    Galveston, Texas, 77555

  • Northshore University HealthSystem

    Glenview, Illinois, 60026

  • University of North Dakota

    Grand Forks, North Dakota, 58202

  • Prisma Health Upstate

    Greenville, South Carolina, 29605

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

    Honolulu, Hawaii, 96822

  • Memorial Hermann Health System

    Houston, Texas, 77024

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77024

  • University of Mississippi Medical Center (UMMC)

    Jackson, Mississippi, 39216

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160

  • UTMB Health League City Campus Hospital & Clinics

    League City, Texas, 77573

  • University of Kentucky

    Lexington, Kentucky, 40506

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of South Alabama

    Mobile, Alabama, 36688

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Yale School of Medicine (YSM)

    New Haven, Connecticut, 06510

  • Louisiana State University (LSU)

    New Orleans, Louisiana, 70112

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • Ochsner Health System

    New Orleans, Louisiana, 70115

  • Tulane University

    New Orleans, Louisiana, 70118

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University (Pregnancy)

    New York, New York, 10032

  • Columbia University

    New York, New York, 10032

  • ChristianaCare Health System

    Newark, Delaware, 19718

  • McKay-Dee Hospital

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center (OUHSC)

    Oklahoma City, Oklahoma, 73104

  • University Of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Banner University Medical Center (BUMC) - Phoenix

    Phoenix, Arizona, 85006

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15213

  • MaineHealth

    Portland, Maine, 04101

  • Women & Infants Hospital

    Providence, Rhode Island, 02905

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • NewYork-Presbyterian Hospital

    Queens, New York, 11355

  • WakeMed Health & Hospitals

    Raleigh, North Carolina, 27610

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Bateman Horne Center

    Salt Lake City, Utah, 84102

  • Intermountain Medical Center (Intermountain Healthcare)

    Salt Lake City, Utah, 84107

  • University of Utah

    Salt Lake City, Utah, 84112

  • University of Utah Health

    Salt Lake City, Utah, 84132

  • LDS Hospital - Intermountain Healthcare

    Salt Lake City, Utah, 84143

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • University of California San Francisco (Pregnancy Cohort)

    San Francisco, California, 94115

  • University of California, San Francisco (UCSF)

    San Francisco, California, 94143

  • University of Washington

    Seattle, Washington, 98104

  • Institute for Systems Biology (ISB)

    Seattle, Washington, 98109

  • Swedish Medical Center

    Seattle, Washington, 98109

  • Sanford Health

    Sioux Falls, South Dakota, 57106

  • Providence Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Stanford University

    Stanford, California, 94305

  • University of Arizona

    Tucson, Arizona, 85724

  • George Washington University

    Washington D.C., District of Columbia, 20052

  • Howard University

    Washington D.C., District of Columbia, 20059

Other trials in United States

Puerto Rico1 site

  • Hispanic Alliance for Clinical and Translational Research

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: 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.

Read the detailed description

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

Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05172024
Study groupRoleWhat they receive
Participants with SARS-CoV-2 InfectionNot described
Participants without SARS-CoV-2 InfectionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of candidate PASC symptoms over time

    Measured: Up to 4 Years

  2. Prevalence of candidate PASC symptoms over time

    Measured: Up to 4 Years

Secondary outcomes (2)

  1. Incidence of organ injury

    Measured: Up to 4 Years

  2. Incidence of clinical disease

    Measured: Up to 4 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start29 Oct 2021
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
15,172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05172024
Sponsor's protocol ID
21-01226
Status last verified
Dec 2025
First submitted
27 Dec 2021
Last updated
15 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

Publications

  • 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.

    PubMed 40302048

  • 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.

    PubMed 39133923

  • 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.

    PubMed 38991216

  • 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.

    PubMed 37352211

  • 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.

    PubMed 37162923

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV2 Infection, run by NYU Langone Health at 86 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of candidate PASC symptoms over time (time frame: Up to 4 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05172024, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.

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