Understanding the Long-term Impact of COVID on Children and Families

• ClinicalTrials.gov Identifier: NCT05172011
• Recruitment Status: Recruiting
• First Posted: December 29, 2021
• Last Update Posted: April 7, 2023
• Sponsor: NYU Langone Health
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): NYU Langone Health

Study Description

Brief Summary:

This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals age 0-25 years who will enter the cohort with and without SARS-CoV-2 infection at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without PASC symptoms will be followed to identify risk factors and occurrence of PASC. This study will be conducted in the United States and participants 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 symptoms will be reported by participants 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-CoV-2 Infection

Detailed Description:

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

Study Design

• Study Type: Observational
• Estimated Enrollment: 40000 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: NIH RECOVER: A Multi-site Observational Study of Post-acute Sequalae of SARS-CoV-2 Infection in Children
• Actual Study Start Date: March 1, 2022
• Estimated Primary Completion Date: April 1, 2025
• Estimated Study Completion Date: May 23, 2025

Groups and Cohorts

Group/Cohort
Extant, Clinical and De Novo Cohort -- INFECTED; SARS-CoV-2 infected children and young adults with and without current or prior PASC-like symptoms, including infected individuals with history of multisystem inflammatory syndrome in children (MIS-C), and infants born in the context of maternal SARS-CoV-2 infection during pregnancy
Extant, Clinical and De Novo Cohort -- UNINFECTED; SARS-CoV-2 uninfected children and infants born to uninfected mothers
Acute Cohort -- INFECTED; Newly SARS-CoV-2 infected individuals (≤4 weeks since onset of symptoms or positive laboratory testing)
Acute Cohort -- UNINFECTED; Contemporaneous SARS-CoV-2 uninfected individuals selected from the same population as newly SARS-CoV-2 infected individuals
Post-acute cohort -- INFECTED; Post-acute infected individuals (>4 weeks after initial symptoms or positive laboratory testing) in the extant, clinical and de novo cohorts, including infants born in the context of maternal SARS-CoV-2 infection during pregnancy, will be enrolled 1-24 months after initial SARS-CoV-2 infection.
Post-acute cohort -- UNINFECTED; Uninfected individuals will be derived from a similar population with respect to age, sex, race and ethnicity, geographic origin, sociodemographics, and time of enrollment as the infected individuals.
Post-COVID Vaccine Myocarditis; Individuals with history of myocarditis after receiving COVID-19 vaccine.
Primary Caregivers; The primary caregiver of the child or young adult may optionally participate in the study.
Biological Parent; If the primary caregiver is a biological parent, the other biological parent may optionally participate in the study

Outcome Measures

Primary Outcome Measures :

1. Caregiver SARS-CoV-2 Infection Status [ Time Frame: Baseline ]
   Initial SARS-CoV-2 infection is reported via remote patient report (electronic, paper or telephone assessments) and EHR. Infection categories include: SARS CoV 2 PCR result, SARS CoV 2 antigen result, SARS CoV 2 antibody result, SARS CoV 2 sequencing performed, diagnosed by a doctor based on symptoms, suspected by participant but not diagnosed by a doctor.
2. Child SARS-CoV-2 Infection Status [ Time Frame: Baseline ]
   Initial SARS-CoV-2 infection is reported via remote patient report (electronic, paper or telephone assessments) and EHR. Infection categories include: SARS CoV 2 PCR result, SARS CoV 2 antigen result, SARS CoV 2 antibody result, SARS CoV 2 sequencing performed, diagnosed by a doctor based on symptoms, suspected by participant but not diagnosed by a doctor.
3. Caregiver Severity of SARS-CoV-2 Infection [ Time Frame: Baseline ]
   Severity levels are reported via remote patient report (electronic, paper or telephone assessments) and EHR. NIH severity levels include: asymptomatic or presymptomatic, mild illness, moderate illness, severe illness, and critical illness.
4. Child Severity of SARS-CoV-2 Infection [ Time Frame: Baseline ]
   Severity levels are reported via remote patient report (electronic, paper or telephone assessments) and EHR. NIH severity levels include: asymptomatic or presymptomatic, mild illness, moderate illness, severe illness, and critical illness.
5. Caregiver Previous In-Hospital SARS-CoV-2 Treatment Record [ Time Frame: Baseline ]
   Treatments will be reported via remote patient report (electronic, paper, or telephone assessment) and EHR -- Treated with corticosteroids , Treated with hydroxychloroquine, Treated with lopinavir, ritonavir, other antiviral, Treated with monoclonal antibody, Treated with therapeutic anticoagulation, Treated with antibiotics.
6. Child Previous In-Hospital SARS-CoV-2 Treatment Record [ Time Frame: Baseline ]
   Treatments will be reported via remote patient report (electronic, paper, or telephone assessment) and EHR -- Treated with corticosteroids , Treated with hydroxychloroquine, Treated with lopinavir, ritonavir, other antiviral, Treated with monoclonal antibody, Treated with therapeutic anticoagulation, Treated with antibiotics.
7. Caregiver Symptoms [ Time Frame: Baseline, up to Month 48 ]
   Symptoms will be reported via remote patient report, in-person patient report, or EHR
8. Child Symptoms [ Time Frame: Baseline, up to Month 48 ]
   Symptoms will be reported via remote patient report, in-person patient report, or EHR -- symptoms include: Nasal Congestion, Trouble breathing, Pain when breathing, Chest pain, Palpitations/heart racing, Dizziness/lightheadedness, Fainting, Change in hearing/ringing in ears, Blurred vision, Change in smell, Change in taste, Problems with teeth or gums, Tremors/shakiness, Feeling off-balance or unsteady, Feeling tingling or "pins and needles", Seizures/fits, Muscle weakness, Difficulty sleeping, Excessive sleepiness, Fatigue/Low energy, Feeling exhausted after walking, Poor appetite, Stomach pains/cramps, Nausea, Vomiting, Diarrhea, Constipation, Problems with urination, Skin rash, Problems with memory, Problems with concentration, Speech difficulty, Anxiety, Depression, Body pain, Headache, Problems swallowing or chewing, Change in menstruation
9. Caregiver SARS-CoV-2 Vaccination Status [ Time Frame: Baseline, up to Month 48 ]
   Vaccination in status will be reported via remote patient report, in-person patient report, or EHR.
10. Change in Child SARS-CoV-2 Vaccination Status [ Time Frame: Week 8, up to Month 48 ]
    Vaccination in status will be reported via remote patient report, in-person patient report, or EHR.
11. Change in Caregiver SARS-CoV-2 Treatment Record [ Time Frame: Month 12, up to Month 48 ]
    Treatments will be reported via remote patient report, in-person patient report, or EHR -- Treated with corticosteroids, Treated with hydroxychloroquine, Treated with lopinavir, ritonavir, other antiviral, Treated with monoclonal antibody, Treated with therapeutic anticoagulation, Treated with antibiotics.
12. Change in Child SARS-CoV-2 Treatment Record [ Time Frame: Week 8, up to Month 48 ]
    Treatments will be reported via remote patient report, in-person patient report, or EHR -- Treated with corticosteroids, Treated with hydroxychloroquine, Treated with lopinavir, ritonavir, other antiviral, Treated with monoclonal antibody, Treated with therapeutic anticoagulation, Treated with antibiotics.

Biospecimen Retention:   Samples With DNA

Tier 1: Saliva and blood, Tier 2: Blood and urine, Tier 3: Blood, sputum, nasal swab, oral swab, skin swab, stool, urine

Eligibility Criteria

• Ages Eligible for Study: up to 25 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Infected: Individuals less than 25 years of age meeting WHO criteria for suspected, probable or confirmed SARS-CoV-2 infection on or after March 1, 2020; or those born to a mother meeting these criteria during pregnancy.

Uninfected: Individuals less than 25 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:

Patients will be eligible for inclusion according to the following criteria:

1. Ages newborn-25 years
2. Infected individuals will have suspected, probable, or confirmed SARS-CoV-2 infection as defined by WHO criteria within 24 months of enrollment or have been born to a mother meeting these criteria during pregnancy (congenitally exposed)
3. Children/young adults with or without history of MIS-C are eligible
4. Children/young adults with or without history of SARS-CoV-2 vaccination are eligible
5. Children/young adults with evidence of past SARS-CoV-2 infection based on serum antibody profile are eligible (with or without history of acute symptoms)
6. Children/young adults with recurrent SARS-CoV-2 infections and those with post-vaccination (breakthrough) infections are eligible to participate
7. Participants are eligible without exclusion related to sex, race/ethnicity, geography, nationality, severity of disease, or underlying health conditions

Children/Young Adults with Suspected SARS-Cov-2 Infection

Children/young adults who meet these clinical criteria:

At least one of these clinical criteria:

• Acute onset of fever and cough OR
• Acute onset of ANY THREE OR 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.

AND at least one of these epidemiological criteria:

1. Residing or working in an area with a high risk of transmission of virus: closed residential, school or camp settings 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. Any known household contact or any member of the household working in any health care setting, including within health facilities or within the community; anytime within the 14 days before symptom onset.

4. A patient with history of severe acute respiratory illness (SARI):

   - SARI: acute respiratory infection with history of fever or measured fever of ≥ 38 C°; and cough; with onset within the last 10 days; and requires hospitalization

5. An asymptomatic person not meeting epidemiologic criteria with a positive SARS-CoV-2 Antigen-RDT.

Children/Young Adults with Probable SARS-Cov-2 Infection

1. A patient who meets clinical criteria above AND is a contact of a probable or confirmed case or linked to a COVID-19 cluster; OR
2. A suspect case with chest imaging showing findings suggestive of COVID-19 disease; OR
3. A person with recent onset of anosmia (loss of smell) or ageusia (loss of taste) in the absence of any other identified cause

Children/Young Adults with Confirmed SARS-Cov-2 Infection

1. A person with a positive Nucleic Acid Amplification Test (NAAT); OR
2. A person with a positive SARS-CoV-2Antigen-RDT AND meeting either the probable case definition or suspect criteria A OR B; OR
3. An asymptomatic person with a positive SARS-CoV-2 Antigen-RDT who is a contact of a probable or confirmed case

Children/Young Adults with Asymptomatic SARS-CoV-2 Infection

1. A person without history of acute COVID-19 symptoms who has one or more of the epidemiological exposures for suspected infection and who also meets criteria b or c for suspected or probable infection, or who meets any of the criteria for confirmed infection
2. A person without history of acute COVID-19 symptoms who has positive nucleocapsid antibody test result in medical history or Tier 1 testing with or without NAAT or RDT testing or known contact to a probable or confirmed case.

Non-Infected Cohort

A person who meets the following criteria will qualify for enrollment as a non-infected control subject:

1. Does not meet WHO criteria for a suspected, probable, or confirmed case of SARS-CoV-2 infection AND
2. Does not have serological evidence of past asymptomatic SARS-CoV-2 infection in medical history or Tier 1 testing, AND
3. Lives in the same communities or recruited from the same sources as those in the SARS-CoV-2 infected cohort, AND
4. Either not hospitalized for any reason in prior 3 months, or hospitalized (with or without ICU stay) within the prior 3 months
5. Uninfected individuals may participate independent of their vaccination status
6. Uninfected individuals who develop SARS-CoV-2 infection during the study period will be reassigned to the SARS-Cov-2 infected group and will be considered to have been enrolled prior to SARS-CoV-2 infection.

Children (≤3 years of age) born in and out of the context of maternal SARS-CoV-2 infection during pregnancy.

1. Children ≤3 years of age born to a childbearing parent with history of suspected, probable, or confirmed SARS-COV-2 infection during pregnancy (according the same criteria listed for the infected child cohort) will be enrolled in the study from existing research cohorts at the maternal fetal medicine sites in the RECOVER. network.
2. Children ≤3 years of age born to a childbearing parent without history of SARS-COV-2 infection during pregnancy (according to the same criteria listed for the non-infected child cohort) will also be enrolled from the same existing research cohorts at maternal fetal medicine sites in the RECOVER network.

Children with MIS-C

Children/young adults with SARS-CoV-2 infection who have history of MIS-C meeting the CDC definition:

1. An individual aged <21 years presenting with fever*, laboratory evidence of inflammation**, and evidence of clinically severe illness requiring hospitalization, with multisystem (>2) organ involvement (cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological); AND
2. No alternative plausible diagnoses; AND

3. Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test; or exposure to a suspected or confirmed COVID-19 case within the 4 weeks prior to the onset of symptoms.

   • Fever >38.0°C for ≥24 hours, or report of subjective fever lasting ≥24 hours **Including, but not limited to, one or more of the following: an elevated C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fibrinogen, procalcitonin, d-dimer, ferritin, lactic acid dehydrogenase (LDH), or interleukin 6 (IL-6), elevated neutrophils, reduced lymphocytes and low albumin Young adults with past history of MIS-C with current ages 22-25 years are eligible to participate.

Children/Young Adults with Post-Vaccine Myocarditis

1. Age 3-25 years
2. Recipient of mRNA COVID-19 vaccination within last 4 weeks
3. Children or young adults with or without history of SARS-CoV-2 infection are eligible
4. Children or young adults with or without history of MIS-C are eligible (if any prior MIS-C-related cardiac abnormalities are known to have resolved pre-vaccination)
5. No other known auto-immune or other immune dysregulation disease
6. Participants are eligible without exclusion related to sex, race/ethnicity, geography, nationality, severity of disease, or underlying health conditions
7. Clinical evidence of probable or confirmed myocarditis based on the following criteria:

Children and young adults ages 3-25 years with presence of ≥1 new or worsening of the following clinical symptoms:

• chest pain, pressure, or discomfort
• dyspnea, shortness of breath, or pain with breathing
• palpitations
• syncope

OR, children aged 3-12 years might instead have ≥2 of the following symptoms:

• irritability
• vomiting
• poor feeding
• tachypnea

• lethargy AND

  ≥1 new finding of:

• troponin level above upper limit of normal (any type of troponin)
• abnormal electrocardiogram (ECG or EKG) or rhythm monitoring findings consistent with myocarditis
• abnormal cardiac function or wall motion abnormalities on echocardiogram
• cardiac MRI findings consistent with myocarditis
• histopathologic confirmation of myocarditis (Definite myocarditis)¶ AND
• No other identifiable cause of the symptoms and finding

Entry criteria are adapted from the CDC definition based on the assumptions that COVID-19 vaccines will be available in the future to children <5 years of age.

Primary Caregiver Entry Criteria

1. A primary caregiver is defined as an individual, such as a family member (biological or nonbiological) or legal guardian, who is responsible for the care of the enrolled child and resides in the same household as the child. When possible, the primary caregiver identified at study entry will remain in the same role throughout the study.
2. The primary caregiver is the caregiver who spends the most time with the child or young adult, has substantial responsibility for taking care of him/her on a daily basis, and is most knowledgeable about him/her.
3. If two or more persons share equally in the caregiver responsibilities for the child or young adult, the person selected by the family to fill out study forms both about themselves and the child will be considered the primary caregiver.
4. If a biological family member primary caregiver has not reached the legal age of majority in their jurisdiction, the parent/legal guardian for the minor primary caregiver will provide consent for participation, with assent provided by the minor caregiver.
5. A nonbiological primary caregiver or legal guardian serving as primary caregiver must be above the legal age of majority in their jurisdiction.
6. The primary caregiver cannot be a babysitter or other childcare provider who receives money to care for the child.

Biological Parent Entry Criteria

- If the primary caregiver is a biological parent of the child or young adult who is participating in the study, the other biological parent may be enrolled to provide a home sample of saliva for DNA analysis.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Any child, young adult, caregiver, or other biological parent who in the opinion of the site investigator may be at increased risk of adverse events during participation in the study, or who may not be able to complete study procedures due to co-morbid disease or disability.
2. Any young adult age above the age of majority who lacks capacity to provide consent
3. Nonviable neonates and neonates of uncertain viability as determined by the treating physician
4. Any child, young, adult, or caregiver with co-morbid illness with expected survival <2 years
5. Any child who is being given up for adoption or is a ward of the state
6. Any caregiver or other biological parent who is incarcerated, or who lacks capacity to provide consent
7. Currently enrolled in the study Understanding the Long-term Impact of COVID-19 in Adults

Contacts and Locations

Contacts

Contact: Stuart Katz, MD, MS; 1-833-422-6819; Stuartz.Katz@nyulangone.org

Locations

United States, Alabama

University of Alabama at Birmingham (Pregnancy Cohort); Not yet recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator: Alan Tita, MD, PhD

United States, Arkansas

Arkansas Children's Hospital and Research Institute; Recruiting

Little Rock, Arkansas, United States, 72202

Principal Investigator: Katherine Irby, MD

United States, California

University of California San Diego; Not yet recruiting

La Jolla, California, United States, 92093

Principal Investigator: Terry Jernigan, PhD

Children's Hospital Los Angeles; Recruiting

Los Angeles, California, United States, 90027

Principal Investigator: John Wood, MD, PhD

University of California San Diego Health - Rady Children's Hospital; Not yet recruiting

San Diego, California, United States, 92123

Principal Investigator: Kelan Tantisira, MD

University of California San Francisco (Pregnancy Cohort); Not yet recruiting

San Francisco, California, United States, 94115

Principal Investigator: Valerie Flaherman, MD, MPH

University of California San Francisco; Not yet recruiting

San Francisco, California, United States, 94143

Principal Investigator: Charles Chiu, MD, PhD

United States, Connecticut

Connecticut Children's Medical Center; Not yet recruiting

Hartford, Connecticut, United States, 06106

Principal Investigator: Juan Salazar, MD, MPH

Yale School of Medicine (YSM); Not yet recruiting

New Haven, Connecticut, United States, 06510

Principal Investigator: Christian Pettker, MD

Principal Investigator: Vince Faustino, MD

United States, Delaware

ChristianaCare Health System; Not yet recruiting

Newark, Delaware, United States, 19718

Principal Investigator: Matthew Hoffman, MD, MPH

Nemours Children's Health; Recruiting

Wilmington, Delaware, United States, 19803

Principal Investigator: Judith Ross, MD

United States, District of Columbia

George Washington University; Active, not recruiting

Washington, District of Columbia, United States, 20052

United States, Hawaii

Kapi'olani Medical Center for Women & Children; Recruiting

Honolulu, Hawaii, United States, 96826

Principal Investigator: Jessica Kosut, MD

United States, Illinois

Northwestern University; Not yet recruiting

Evanston, Illinois, United States, 60208

Principal Investigator: Emily Miller, MD, MPH

Northshore University HealthSystem; Not yet recruiting

Glenview, Illinois, United States, 60026

Principal Investigator: Beth Plunkett, MD

American Academy of Pediatrics; Not yet recruiting

Itasca, Illinois, United States, 60143

Principal Investigator: Lynn Olson, PhD

United States, Kansas

American Academy of Family Physicians; Not yet recruiting

Leawood, Kansas, United States, 66211

Principal Investigator: Christina Hester, PhD, MPH

United States, Kentucky

University of Louisville - Norton Children's Hospital; Not yet recruiting

Louisville, Kentucky, United States, 40202

Principal Investigator: Michelle Stevenson, MD

United States, Louisiana

Louisiana State University (LSU) - Pennington Biomedical Research Center; Recruiting

Baton Rouge, Louisiana, United States, 70808

Principal Investigator: Daniel Hsia, MD

Tulane University; Not yet recruiting

New Orleans, Louisiana, United States, 70118

Principal Investigator: Margaret Huntwork, MD, MSEd

United States, Maryland

Johns Hopkins University; Not yet recruiting

Baltimore, Maryland, United States, 21218

Principal Investigator: Shelby Kutty, MD, PhD

United States, Massachusetts

Mass General Brigham - Harvard University; Active, not recruiting

Boston, Massachusetts, United States, 02114

Harvard Medical School; Active, not recruiting

Boston, Massachusetts, United States, 02115

Harvard School Of Public Health; Active, not recruiting

Boston, Massachusetts, United States, 02115

Northeastern University; Not yet recruiting

Boston, Massachusetts, United States, 02115

Principal Investigator: Emily Zimmerman, PhD

United States, Michigan

Central Michigan University - College of Medicine; Not yet recruiting

Detroit, Michigan, United States, 48201

Principal Investigator: Usha Sethuraman, MD

United States, Minnesota

Mayo Clinic; Active, not recruiting

Rochester, Minnesota, United States, 55905

United States, Nebraska

University Of Nebraska Medical Center; Recruiting

Omaha, Nebraska, United States, 68198

Principal Investigator: Russell McCulloh, MD

United States, New Hampshire

Dartmouth-Hitchcock; Not yet recruiting

Lebanon, New Hampshire, United States, 03766

Principal Investigator: Paul Palumbo, MD

United States, New Jersey

Hackensack University Medical Center; Not yet recruiting

Hackensack, New Jersey, United States, 07601

Principal Investigator: Judy Aschner, MD

Rutgers University; Not yet recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator: Sunanda Guar, MD

Saint Peter's University Hospital; Not yet recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator: Kristy Palomares, MD

The Pediatric Specialty Center at Saint Barnabas; Not yet recruiting

West Orange, New Jersey, United States, 07052

Principal Investigator: Uzma Hasan, MD

United States, New Mexico

University of New Mexico Health Sciences Center; Recruiting

Albuquerque, New Mexico, United States, 87102

Principal Investigator: Hengameh Raissy, PharmD

United States, New York

NYU Langone Health; Recruiting

New York, New York, United States, 10016

Principal Investigator: Moriah Thomason, PhD

Columbia University; Recruiting

New York, New York, United States, 10027

Principal Investigator: Melissa Stockwell, MD

Columbia University (Pregnancy); Recruiting

New York, New York, United States, 10032

Principal Investigator: Uma M Reddy, MD, MPH

NewYork-Presbyterian Hospital; Not yet recruiting

Queens, New York, United States, 11355

Principal Investigator: Daniel Skupski, MD

New York Medical College; Not yet recruiting

Valhalla, New York, United States, 10595

Principal Investigator: Sheila Nolan, MD

United States, North Carolina

University of North Carolina (UNC) at Chapel Hill; Not yet recruiting

Chapel Hill, North Carolina, United States, 27516

Principal Investigator: John Thorp, MD

Duke University Medical Center; Not yet recruiting

Durham, North Carolina, United States, 27710

Principal Investigator: Brenna Hughes, MD, MSc

WakeMed Health & Hospitals; Not yet recruiting

Raleigh, North Carolina, United States, 27610

Principal Investigator: Carmen Beamon, MD

United States, Ohio

Good Samaritan Hospital; Not yet recruiting

Cincinnati, Ohio, United States, 45220

Principal Investigator: Mounira Habli, MD

University Hospitals MacDonald's Women's Hospital; Not yet recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator: David Hackney, MD

Metrohealth System; Not yet recruiting

Cleveland, Ohio, United States, 44109

Principal Investigator: David Kaelber, MD

The MetroHealth System (Pregnancy Cohort); Not yet recruiting

Cleveland, Ohio, United States, 44109

Principal Investigator: Jennifer Bailit, MD, MPH

The Ohio State University - Wexner Medical Center; Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator: Maged Costantine, MD

Miami Valley Hospital; Not yet recruiting

Dayton, Ohio, United States, 45409

Principal Investigator: Samantha Wiegand, MD

Children's Mercy Hospital; Not yet recruiting

Fairfield, Ohio, United States, 45014

Principal Investigator: Rangaraj Selvarangan, PhD

United States, Oklahoma

University of Oklahoma Health Sciences Center (OUHSC); Recruiting

Oklahoma City, Oklahoma, United States, 73104

Principal Investigator: Amanda Bogie, MD

United States, Pennsylvania

University of Pennsylvania; Not yet recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator: Samuel Parry, MD

University of Pittsburgh Medical Center (UPMC); Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Principal Investigator: Hyagriv Simhan, MD, MS

United States, Rhode Island

Rhode Island Hospital; Recruiting

Providence, Rhode Island, United States, 02903

Principal Investigator: Sean Deoni, PhD

Women & Infants Hospital; Not yet recruiting

Providence, Rhode Island, United States, 02905

Principal Investigator: Dwight Rouse, MD

United States, South Carolina

Medical University of South Carolina (MUSC); Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator: Andrew Atz, MD

Prisma Health Upstate; Not yet recruiting

Greenville, South Carolina, United States, 29605

Principal Investigator: Kacey Eichelberger, MD

United States, South Dakota

Avera Research Institute; Recruiting

Sioux Falls, South Dakota, United States, 57108

Principal Investigator: Amy Elliott, PhD

United States, Texas

University of Texas Medical Branch (UTMB) Galveston; Recruiting

Galveston, Texas, United States, 77555

Principal Investigator: George Saade, MD

University of Texas Health Science Center at Houston; Not yet recruiting

Houston, Texas, United States, 77024

Principal Investigator: Hector Mendez-Figueroa, MD, MD

Baylor College of Medicine; Not yet recruiting

Houston, Texas, United States, 77030

Principal Investigator: Ananth Annapragada, PhD

United States, Utah

University of Utah Health; Recruiting

Salt Lake City, Utah, United States, 84132

Principal Investigator: Torri Metz, MD, MS

United States, Vermont

University of Vermont (UVM) Children's Hospital; Not yet recruiting

Burlington, Vermont, United States, 05401

Principal Investigator: Kelly Cowan, MD

United States, Virginia

Virginia Commonwealth University; Recruiting

Richmond, Virginia, United States, 23284

Principal Investigator: Amy Salisbury, PhD, RN

United States, West Virginia

West Virginia University; Recruiting

Morgantown, West Virginia, United States, 26506

Principal Investigator: Lesley Cottrell, PhD

United States, Wisconsin

Medical College Of Wisconsin; Not yet recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator: Anna Palatnik, MD

Sponsors and Collaborators

NYU Langone Health

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Stuart Katz, MD, MS; NYU Langone Health
• Principal Investigator: Andrea Troxel, ScD; NYU Langone Health
• Principal Investigator: Leora Horwitz, MD; NYU Langone Health

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT05172011
• Other Study ID Numbers: 21-01231
• First Posted: December 29, 2021
• Last Update Posted: April 7, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All of the individual participant data collected during the trial, after deidentification 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: Data will become available beginning 9 months with no end date.
• Access Criteria: The investigator who proposed to use the data 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

Keywords provided by NYU Langone Health:

Post Acute Sequalae of SARS-CoV-2 (PASC)

Additional relevant MeSH terms:

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