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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05172024
Recruitment Status : Recruiting
First Posted : December 29, 2021
Last Update Posted : May 20, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
NYU Langone Health

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
SARS-CoV2 Infection

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

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Study Type : Observational
Estimated 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 : October 29, 2021
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : May 23, 2025


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



Primary Outcome Measures :
  1. Incidence of candidate PASC symptoms over time [ Time Frame: Up to 4 Years ]
  2. Prevalence of candidate PASC symptoms over time [ Time Frame: Up to 4 Years ]

Secondary Outcome Measures :
  1. Incidence of organ injury [ Time Frame: Up to 4 Years ]
  2. Incidence of clinical disease [ Time Frame: Up to 4 Years ]

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05172024


Contacts
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Contact: Leora Horwitz, MD 1-833-422-6819 RECOVER_CSC@nyulangone.org
Contact: MeeLee Tom, MS, CCRA 1-844.226.8192 RECOVER_CSC@nyulangone.org

Locations
Show Show 86 study locations
Sponsors and Collaborators
NYU Langone Health
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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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
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT05172024    
Other Study ID Numbers: 21-01226
First Posted: December 29, 2021    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
COVID-19
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases