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

SARS-CoV2 Infection Clinical Trial

Official title:

NIH RECOVER: A Multi-site Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05172024
• Other study ID #: 21-01226
• Status: Recruiting
• Start date: October 29, 2021
• Est. completion date: May 23, 2025

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: Leora Horwitz, MD
• Phone: 1-833-422-6819
• Email: RECOVER_CSC[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14880
• Est. completion date: May 23, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV2 Infection

Locations

Country	Name	City	State
Puerto Rico	Hispanic Alliance for Clinical and Translational Research	San Juan
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	Kaiser Permanente Georgia	Atlanta	Georgia
United States	Morehouse School of Medicine (MSM)	Atlanta	Georgia
United States	St. David's Health Care	Austin	Texas
United States	Louisiana State University - Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Alabama at Birmingham (Pregnancy Cohort)	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center (BIDMC)	Boston	Massachusetts
United States	Boston University	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Harvard Medical School	Boston	Massachusetts
United States	Harvard School Of Public Health	Boston	Massachusetts
United States	Mass General Brigham - Harvard University	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Cambridge Health Alliance (CHA)	Cambridge	Massachusetts
United States	University of North Carolina (UNC) at Chapel Hill	Chapel Hill	North Carolina
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Metrohealth System	Cleveland	Ohio
United States	The MetroHealth System (Pregnancy Cohort)	Cleveland	Ohio
United States	University Hospitals MacDonald's Women's Hospital	Cleveland	Ohio
United States	The Ohio State University - Wexner Medical Center	Columbus	Ohio
United States	Miami Valley Hospital	Dayton	Ohio
United States	Denver Health and Hospital Authority	Denver	Colorado
United States	University of Colorado Denver	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Northwestern University	Evanston	Illinois
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	University of Texas Medical Branch (UTMB) Galveston	Galveston	Texas
United States	Northshore University HealthSystem	Glenview	Illinois
United States	University of North Dakota	Grand Forks	North Dakota
United States	Prisma Health Upstate	Greenville	South Carolina
United States	University of Hawai'i - Manoa's John A. Burns School of Medicine	Honolulu	Hawaii
United States	Memorial Hermann Health System	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Mississippi Medical Center (UMMC)	Jackson	Mississippi
United States	University of Kansas Medical Center (KUMC)	Kansas City	Kansas
United States	UTMB Health League City Campus Hospital & Clinics	League City	Texas
United States	University of Kentucky	Lexington	Kentucky
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Medical College Of Wisconsin	Milwaukee	Wisconsin
United States	University of South Alabama	Mobile	Alabama
United States	West Virginia University	Morgantown	West Virginia
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	Yale School of Medicine (YSM)	New Haven	Connecticut
United States	Louisiana State University (LSU)	New Orleans	Louisiana
United States	Ochsner Health System	New Orleans	Louisiana
United States	Tulane University	New Orleans	Louisiana
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	Columbia University	New York	New York
United States	Columbia University (Pregnancy)	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	ChristianaCare Health System	Newark	Delaware
United States	McKay-Dee Hospital	Ogden	Utah
United States	University of Oklahoma Health Sciences Center (OUHSC)	Oklahoma City	Oklahoma
United States	University Of Nebraska Medical Center	Omaha	Nebraska
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner University Medical Center (BUMC) - Phoenix	Phoenix	Arizona
United States	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania
United States	MaineHealth	Portland	Maine
United States	Women & Infants Hospital	Providence	Rhode Island
United States	Utah Valley Regional Medical Center	Provo	Utah
United States	NewYork-Presbyterian Hospital	Queens	New York
United States	WakeMed Health & Hospitals	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	Bateman Horne Center	Salt Lake City	Utah
United States	Intermountain Medical Center (Intermountain Healthcare)	Salt Lake City	Utah
United States	LDS Hospital - Intermountain Healthcare	Salt Lake City	Utah
United States	University of Utah	Salt Lake City	Utah
United States	University of Utah Health	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
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	Institute for Systems Biology (ISB)	Seattle	Washington
United States	Swedish Medical Center	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	Sanford Health	Sioux Falls	South Dakota
United States	Providence Sacred Heart Medical Center	Spokane	Washington
United States	Stanford University	Stanford	California
United States	University of Arizona	Tucson	Arizona
United States	George Washington University	Washington	District of Columbia
United States	Howard University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of candidate PASC symptoms over time		Up to 4 Years
Primary	Prevalence of candidate PASC symptoms over time		Up to 4 Years
Secondary	Incidence of organ injury		Up to 4 Years
Secondary	Incidence of clinical disease		Up to 4 Years