Understanding the Long-term Impact of COVID on Children and Families
NCT ID: NCT05172011
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
15028 participants
OBSERVATIONAL
2022-03-01
2027-05-23
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
OTHER
Study Groups
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Post-COVID Vaccine Myocarditis
Individuals with history of myocarditis after receiving COVID-19 vaccine.
No interventions assigned to this group
Primary Caregivers
The primary caregiver of the child or young adult may optionally participate in the study.
No interventions assigned to this group
Biological Parent
If the primary caregiver is a biological parent, the other biological parent may optionally participate in the study
No interventions assigned to this group
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
No interventions assigned to this group
Extant, Clinical and De Novo Cohort -- UNINFECTED
SARS-CoV-2 uninfected children and infants born to uninfected mothers
No interventions assigned to this group
Acute Cohort -- INFECTED
Newly SARS-CoV-2 infected individuals (≤4 weeks since onset of symptoms or positive laboratory testing)
No interventions assigned to this group
Acute Cohort -- UNINFECTED
Contemporaneous SARS-CoV-2 uninfected individuals selected from the same population as newly SARS-CoV-2 infected individuals
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
25 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Stuart Katz, MD, MS
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Andrea Troxel, ScD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Leora Horwitz, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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University of Alabama at Birmingham (Pregnancy Cohort)
Birmingham, Alabama, United States
Arkansas Children's Hospital and Research Institute
Little Rock, Arkansas, United States
University of California San Diego
La Jolla, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
University of California San Diego Health - Rady Children's Hospital
San Diego, California, United States
University of California San Francisco (Pregnancy Cohort)
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Yale School of Medicine (YSM)
New Haven, Connecticut, United States
ChristianaCare Health System
Newark, Delaware, United States
Nemours Children's Health
Wilmington, Delaware, United States
George Washington University
Washington D.C., District of Columbia, United States
Kapi'olani Medical Center for Women & Children
Honolulu, Hawaii, United States
Northwestern University
Evanston, Illinois, United States
Northshore University HealthSystem
Glenview, Illinois, United States
American Academy of Pediatrics
Itasca, Illinois, United States
American Academy of Family Physicians
Leawood, Kansas, United States
University of Louisville - Norton Children's Hospital
Louisville, Kentucky, United States
Louisiana State University (LSU) - Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Tulane University
New Orleans, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
Mass General Brigham - Harvard University
Boston, Massachusetts, United States
Harvard Medical School
Boston, Massachusetts, United States
Harvard School Of Public Health
Boston, Massachusetts, United States
Northeastern University
Boston, Massachusetts, United States
Central Michigan University - College of Medicine
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University Of Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth-Hitchcock
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Rutgers University
New Brunswick, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
The Pediatric Specialty Center at Saint Barnabas
West Orange, New Jersey, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
NYU Langone Health
New York, New York, United States
Columbia University
New York, New York, United States
Columbia University (Pregnancy)
New York, New York, United States
NewYork-Presbyterian Hospital
Queens, New York, United States
New York Medical College
Valhalla, New York, United States
University of North Carolina (UNC) at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
WakeMed Health & Hospitals
Raleigh, North Carolina, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
University Hospitals MacDonald's Women's Hospital
Cleveland, Ohio, United States
Metrohealth System
Cleveland, Ohio, United States
The MetroHealth System (Pregnancy Cohort)
Cleveland, Ohio, United States
The Ohio State University - Wexner Medical Center
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Children's Mercy Hospital
Fairfield, Ohio, United States
University of Oklahoma Health Sciences Center (OUHSC)
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Women & Infants Hospital
Providence, Rhode Island, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Prisma Health Upstate
Greenville, South Carolina, United States
Avera Research Institute
Sioux Falls, South Dakota, United States
University of Texas Medical Branch (UTMB) Galveston
Galveston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
University of Vermont (UVM) Children's Hospital
Burlington, Vermont, United States
Virginia Commonwealth University
Richmond, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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21-01231
Identifier Type: -
Identifier Source: org_study_id