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

Completed

Conditions studied: SARS-CoV2 Infection

In brief

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.

Key facts

Study ID

NCT05172024

Run by

NYU Langone Health

People needed

15172

Starts

2021-10-29

Expected to finish

2025-10-31

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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;
• 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

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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of South Alabama — Mobile, Alabama, United States
• Banner University Medical Center (BUMC) - Phoenix — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California San Francisco (Pregnancy Cohort) — San Francisco, California, United States
• University of California, San Francisco (UCSF) — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States
• University of Colorado Denver — Denver, Colorado, United States
• Yale School of Medicine (YSM) — New Haven, Connecticut, United States
• ChristianaCare Health System — Newark, Delaware, United States
• George Washington University — Washington D.C., District of Columbia, United States
• Howard University — Washington D.C., District of Columbia, United States
• Kaiser Permanente Georgia — Atlanta, Georgia, United States
• Morehouse School of Medicine (MSM) — Atlanta, Georgia, United States
• Emory University — Atlanta, Georgia, United States
• University of Hawai'i - Mānoa's John A. Burns School of Medicine — Honolulu, Hawaii, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Northwestern University — Evanston, Illinois, United States
• Northshore University HealthSystem — Glenview, Illinois, United States
• University of Kansas Medical Center (KUMC) — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• Louisiana State University - Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• University of Alabama at Birmingham (Pregnancy Cohort) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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