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

NCT05172011 | Active Not Recruiting DMC

• 1 other identifier: 21-01231
• Study Type: observational
• Target: 15,028
• Locations: 1 country
• Sites: 65

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.

Conditions

SARS-CoV-2 Infection

Keywords

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

Outcome Measures

Primary Outcomes (12)

• Caregiver SARS-CoV-2 Infection Status

  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.

  Baseline

• Child SARS-CoV-2 Infection Status

  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.

  Baseline

• Caregiver Severity of SARS-CoV-2 Infection

  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.

  Baseline

• Child Severity of SARS-CoV-2 Infection

  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.

  Baseline

• Caregiver Previous In-Hospital SARS-CoV-2 Treatment Record

  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.

  Baseline

• Child Previous In-Hospital SARS-CoV-2 Treatment Record

  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.

  Baseline

• Caregiver Symptoms

  Symptoms will be reported via remote patient report, in-person patient report, or EHR

  Baseline, up to Month 48

• Child Symptoms

  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

  Baseline, up to Month 48

• Caregiver SARS-CoV-2 Vaccination Status

  Vaccination in status will be reported via remote patient report, in-person patient report, or EHR.

  Baseline, up to Month 48

• Change in Child SARS-CoV-2 Vaccination Status

  Vaccination in status will be reported via remote patient report, in-person patient report, or EHR.

  Week 8, up to Month 48

• Change in Caregiver SARS-CoV-2 Treatment Record

  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.

  Month 12, up to Month 48

• Change in Child SARS-CoV-2 Treatment Record

  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.

  Week 8, up to Month 48

Study Arms (9)

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

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Infected Cohort:
• Ages newborn-25 years
• 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)
• Children/young adults with or without history of MIS-C are eligible
• Children/young adults with or without history of SARS-CoV-2 vaccination are eligible
• 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)
• Children/young adults with recurrent SARS-CoV-2 infections and those with post-vaccination (breakthrough) infections are eligible to participate
• 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:
• 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
• Residing or travel to an area with community transmission anytime within the 14 days before symptom onset; OR

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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.
• Any young adult age above the age of majority who lacks capacity to provide consent
• Nonviable neonates and neonates of uncertain viability as determined by the treating physician
• Any child, young, adult, or caregiver with co-morbid illness with expected survival \<2 years
• Any child who is being given up for adoption or is a ward of the state
• Any caregiver or other biological parent who is incarcerated, or who lacks capacity to provide consent
• Currently enrolled in the study Understanding the Long-term Impact of COVID-19 in Adults

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• NYU Langone Health: lead

Study Sites (65)

University of Alabama at Birmingham (Pregnancy Cohort)

Birmingham, Alabama, 35294, United States

Location

Arkansas Children's Hospital and Research Institute

Little Rock, Arkansas, 72202, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

University of California San Diego Health - Rady Children's Hospital

San Diego, California, 92123, United States

Location

University of California San Francisco (Pregnancy Cohort)

San Francisco, California, 94115, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Yale School of Medicine (YSM)

New Haven, Connecticut, 06510, United States

Location

ChristianaCare Health System

Newark, Delaware, 19718, United States

Location

Nemours Children's Health

Wilmington, Delaware, 19803, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Kapi'olani Medical Center for Women & Children

Honolulu, Hawaii, 96826, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Northshore University HealthSystem

Glenview, Illinois, 60026, United States

Location

American Academy of Pediatrics

Itasca, Illinois, 60143, United States

Location

American Academy of Family Physicians

Leawood, Kansas, 66211, United States

Location

University of Louisville - Norton Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Louisiana State University (LSU) - Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Tulane University

New Orleans, Louisiana, 70118, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Mass General Brigham - Harvard University

Boston, Massachusetts, 02114, United States

Location

Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

Harvard School Of Public Health

Boston, Massachusetts, 02115, United States

Location

Northeastern University

Boston, Massachusetts, 02115, United States

Location

Central Michigan University - College of Medicine

Detroit, Michigan, 48201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University Of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03766, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States

Location

The Pediatric Specialty Center at Saint Barnabas

West Orange, New Jersey, 07052, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87102, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Columbia University

New York, New York, 10027, United States

Location

Columbia University (Pregnancy)

New York, New York, 10032, United States

Location

NewYork-Presbyterian Hospital

Queens, New York, 11355, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

University of North Carolina (UNC) at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

University Hospitals MacDonald's Women's Hospital

Cleveland, Ohio, 44106, United States

Location

Metrohealth System

Cleveland, Ohio, 44109, United States

Location

The MetroHealth System (Pregnancy Cohort)

Cleveland, Ohio, 44109, United States

Location

The Ohio State University - Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Children's Mercy Hospital

Fairfield, Ohio, 45014, United States

Location

University of Oklahoma Health Sciences Center (OUHSC)

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Prisma Health Upstate

Greenville, South Carolina, 29605, United States

Location

Avera Research Institute

Sioux Falls, South Dakota, 57108, United States

Location

University of Texas Medical Branch (UTMB) Galveston

Galveston, Texas, 77555, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77024, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Utah Health

Salt Lake City, Utah, 84132, United States

Location

University of Vermont (UVM) Children's Hospital

Burlington, Vermont, 05401, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• Gross RS, Thaweethai T, Rosenzweig EB, Chan J, Chibnik LB, Cicek MS, Elliott AJ, Flaherman VJ, Foulkes AS, Gage Witvliet M, Gallagher R, Gennaro ML, Jernigan TL, Karlson EW, Katz SD, Kinser PA, Kleinman LC, Lamendola-Essel MF, Milner JD, Mohandas S, Mudumbi PC, Newburger JW, Rhee KE, Salisbury AL, Snowden JN, Stein CR, Stockwell MS, Tantisira KG, Thomason ME, Truong DT, Warburton D, Wood JC, Ahmed S, Akerlundh A, Alshawabkeh AN, Anderson BR, Aschner JL, Atz AM, Aupperle RL, Baker FC, Balaraman V, Banerjee D, Barch DM, Baskin-Sommers A, Bhuiyan S, Bind MC, Bogie AL, Bradford T, Buchbinder NC, Bueler E, Bukulmez H, Casey BJ, Chang L, Chrisant M, Clark DB, Clifton RG, Clouser KN, Cottrell L, Cowan K, D'Sa V, Dapretto M, Dasgupta S, Dehority W, Dionne A, Dummer KB, Elias MD, Esquenazi-Karonika S, Evans DN, Faustino EVS, Fiks AG, Forsha D, Foxe JJ, Friedman NP, Fry G, Gaur S, Gee DG, Gray KM, Handler S, Harahsheh AS, Hasbani K, Heath AC, Hebson C, Heitzeg MM, Hester CM, Hill S, Hobart-Porter L, Hong TKF, Horowitz CR, Hsia DS, Huentelman M, Hummel KD, Irby K, Jacobus J, Jacoby VL, Jone PN, Kaelber DC, Kasmarcak TJ, Kluko MJ, Kosut JS, Laird AR, Landeo-Gutierrez J, Lang SM, Larson CL, Lim PPC, Lisdahl KM, McCrindle BW, McCulloh RJ, McHugh K, Mendelsohn AL, Metz TD, Miller J, Mitchell EC, Morgan LM, Muller-Oehring EM, Nahin ER, Neale MC, Ness-Cochinwala M, Nolan SM, Oliveira CR, Osakwe O, Oster ME, Payne RM, Portman MA, Raissy H, Randall IG, Rao S, Reeder HT, Rosas JM, Russell MW, Sabati AA, Sanil Y, Sato AI, Schechter MS, Selvarangan R, Sexson Tejtel SK, Shakti D, Sharma K, Squeglia LM, Srivastava S, Stevenson MD, Szmuszkovicz J, Talavera-Barber MM, Teufel RJ 2nd, Thacker D, Trachtenberg F, Udosen MM, Warner MR, Watson SE, Werzberger A, Weyer JC, Wood MJ, Yin HS, Zempsky WT, Zimmerman E, Dreyer BP; RECOVER-Pediatric Consortium. Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design. PLoS One. 2024 May 7;19(5):e0285635. doi: 10.1371/journal.pone.0285635. eCollection 2024.

  PMID: 38713673 DERIVED

• Metz TD, Clifton RG, Gallagher R, Gross RS, Horwitz LI, Jacoby VL, Martin-Herz SP, Peralta-Carcelen M, Reeder HT, Beamon CJ, Chan J, Chang AA, Costantine MM, Fitzgerald ML, Foulkes AS, Gibson KS, Guthe N, Habli M, Hackney DN, Hoffman MK, Hoffman MC, Hughes BL, Katz SD, Laleau V, Mallett G, Mendez-Figueroa H, Monzon V, Palatnik A, Palomares KTS, Parry S, Pettker CM, Plunkett BA, Poppas A, Reddy UM, Rouse DJ, Saade GR, Sandoval GJ, Schlater SM, Sciurba FC, Simhan HN, Skupski DW, Sowles A, Thaweethai T, Thomas GL, Thorp JM Jr, Tita AT, Weiner SJ, Weigand S, Yee LM, Flaherman VJ; RECOVER Initiative. Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design. PLoS One. 2023 Dec 21;18(12):e0285351. doi: 10.1371/journal.pone.0285351. eCollection 2023.

  PMID: 38128008 DERIVED

• Gross R, Thaweethai T, Rosenzweig EB, Chan J, Chibnik LB, Cicek MS, Elliott AJ, Flaherman VJ, Foulkes AS, Witvliet MG, Gallagher R, Gennaro ML, Jernigan TL, Karlson EW, Katz SD, Kinser PA, Kleinman LC, Lamendola-Essel MF, Milner JD, Mohandas S, Mudumbi PC, Newburger JW, Rhee KE, Salisbury AL, Snowden JN, Stein CR, Stockwell MS, Tantisira KG, Thomason ME, Truong DT, Warburton D, Wood JC, Ahmed S, Akerlundh A, Alshawabkeh AN, Anderson BR, Aschner JL, Atz AM, Aupperle RL, Baker FC, Balaraman V, Banerjee D, Barch DM, Baskin-Sommers A, Bhuiyan S, Bind MC, Bogie AL, Buchbinder NC, Bueler E, Bukulmez H, Casey BJ, Chang L, Clark DB, Clifton RG, Clouser KN, Cottrell L, Cowan K, D'Sa V, Dapretto M, Dasgupta S, Dehority W, Dummer KB, Elias MD, Esquenazi-Karonika S, Evans DN, Faustino EVS, Fiks AG, Forsha D, Foxe JJ, Friedman NP, Fry G, Gaur S, Gee DG, Gray KM, Harahsheh AS, Heath AC, Heitzeg MM, Hester CM, Hill S, Hobart-Porter L, Hong TKF, Horowitz CR, Hsia DS, Huentelman M, Hummel KD, Iacono WG, Irby K, Jacobus J, Jacoby VL, Jone PN, Kaelber DC, Kasmarcak TJ, Kluko MJ, Kosut JS, Laird AR, Landeo-Gutierrez J, Lang SM, Larson CL, Lim PPC, Lisdahl KM, McCrindle BW, McCulloh RJ, Mendelsohn AL, Metz TD, Morgan LM, Muller-Oehring EM, Nahin ER, Neale MC, Ness-Cochinwala M, Nolan SM, Oliveira CR, Oster ME, Payne RM, Raissy H, Randall IG, Rao S, Reeder HT, Rosas JM, Russell MW, Sabati AA, Sanil Y, Sato AI, Schechter MS, Selvarangan R, Shakti D, Sharma K, Squeglia LM, Stevenson MD, Szmuszkovicz J, Talavera-Barber MM, Teufel RJ 2nd, Thacker D, Udosen MM, Warner MR, Watson SE, Werzberger A, Weyer JC, Wood MJ, Yin HS, Zempsky WT, Zimmerman E, Dreyer BP. Researching COVID to enhance recovery (RECOVER) pediatric study protocol: Rationale, objectives and design. medRxiv [Preprint]. 2023 May 12:2023.04.27.23289228. doi: 10.1101/2023.04.27.23289228.

  PMID: 37214806 DERIVED

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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stuart Katz, MD, MS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Andrea Troxel, ScD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Leora Horwitz, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: December 29, 2021
• Study Start: March 1, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 23, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (65)