Understanding the Long-term Impact of COVID-19 in Adults (RECOVER)
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ClinicalTrials.gov Identifier: NCT05172024 |
Recruitment Status :
Recruiting
First Posted : December 29, 2021
Last Update Posted : October 26, 2023
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Condition or disease |
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SARS-CoV2 Infection |
Study Type : | Observational |
Estimated Enrollment : | 14880 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 |
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Participants with SARS-CoV-2 Infection |
Participants without SARS-CoV-2 Infection |
- Incidence of candidate PASC symptoms over time [ Time Frame: Up to 4 Years ]
- Prevalence of candidate PASC symptoms over time [ Time Frame: Up to 4 Years ]
- Incidence of organ injury [ Time Frame: Up to 4 Years ]
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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.
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:
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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;
- 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
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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
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
Contact: Leora Horwitz, MD | 1-833-422-6819 | RECOVER_CSC@nyulangone.org | |
Contact: Stanley Cobos, CRA | RECOVER_CSC@nyulangone.org |
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 |
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: | October 26, 2023 |
Last Verified: | October 2023 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Infections COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |