Massive study aims to unlock long COVID mysteries in kids

NCT ID NCT05172011

Knowledge-focused Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large observational study is following about 15,000 children and young adults (ages 0-25) across the U.S. to learn more about long COVID, also called PASC. Researchers will track symptoms, infections, and health over time using surveys and medical records. The goal is to identify risk factors and better understand how COVID-19 affects young people in the long run.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to: If successful, this study could reveal why some children develop long COVID and who is most at risk, guiding future prevention and care.
What could go wrong: This is an observational study, not a treatment trial, so it won't directly test any therapy. Results depend on accurate reporting and may take years to fully analyze.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

15,028 people

The number who actually took part.

Started

Mar 2022

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Up to 25 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

COVID-19 long COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SARS-CoV-2 infection

Contacts and locations

Locations

American Academy of Family Physicians

Leawood, Kansas, 66211, United States
American Academy of Pediatrics

Itasca, Illinois, 60143, United States
Arkansas Children's Hospital and Research Institute

Little Rock, Arkansas, 72202, United States
Avera Research Institute

Sioux Falls, South Dakota, 57108, United States
Baylor College of Medicine

Houston, Texas, 77030, United States
Central Michigan University - College of Medicine

Detroit, Michigan, 48201, United States
Children's Hospital Los Angeles

Los Angeles, California, 90027, United States
Children's Mercy Hospital

Fairfield, Ohio, 45014, United States
ChristianaCare Health System

Newark, Delaware, 19718, United States
Columbia University

New York, New York, 10027, United States
Columbia University (Pregnancy)

New York, New York, 10032, United States
Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States
Dartmouth-Hitchcock

Lebanon, New Hampshire, 03766, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
George Washington University

Washington D.C., District of Columbia, 20052, United States
Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Harvard Medical School

Boston, Massachusetts, 02115, United States
Harvard School Of Public Health

Boston, Massachusetts, 02115, United States
Johns Hopkins University

Baltimore, Maryland, 21218, United States
Kapi'olani Medical Center for Women & Children

Honolulu, Hawaii, 96826, United States
Louisiana State University (LSU) - Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States
Mass General Brigham - Harvard University

Boston, Massachusetts, 02114, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States
Metrohealth System

Cleveland, Ohio, 44109, United States
Miami Valley Hospital

Dayton, Ohio, 45409, United States
NYU Langone Health

New York, New York, 10016, United States
Nemours Children's Health

Wilmington, Delaware, 19803, United States
New York Medical College

Valhalla, New York, 10595, United States
NewYork-Presbyterian Hospital

Queens, New York, 11355, United States
Northeastern University

Boston, Massachusetts, 02115, United States
Northshore University HealthSystem

Glenview, Illinois, 60026, United States
Northwestern University

Evanston, Illinois, 60208, United States
Prisma Health Upstate

Greenville, South Carolina, 29605, United States
Rhode Island Hospital

Providence, Rhode Island, 02903, United States
Rutgers University

New Brunswick, New Jersey, 08901, United States
Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States
The MetroHealth System (Pregnancy Cohort)

Cleveland, Ohio, 44109, United States
The Ohio State University - Wexner Medical Center

Columbus, Ohio, 43210, United States
The Pediatric Specialty Center at Saint Barnabas

West Orange, New Jersey, 07052, United States
Tulane University

New Orleans, Louisiana, 70118, United States
University Hospitals MacDonald's Women's Hospital

Cleveland, Ohio, 44106, United States
University Of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of Alabama at Birmingham (Pregnancy Cohort)

Birmingham, Alabama, 35294, United States
University of California San Diego

La Jolla, California, 92093, United States
University of California San Diego Health - Rady Children's Hospital

San Diego, California, 92123, United States
University of California San Francisco

San Francisco, California, 94143, United States
University of California San Francisco (Pregnancy Cohort)

San Francisco, California, 94115, United States
University of Louisville - Norton Children's Hospital

Louisville, Kentucky, 40202, United States
University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87102, United States
University of North Carolina (UNC) at Chapel Hill

Chapel Hill, North Carolina, 27516, United States
University of Oklahoma Health Sciences Center (OUHSC)

Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States
University of Texas Health Science Center at Houston

Houston, Texas, 77024, United States
University of Texas Medical Branch (UTMB) Galveston

Galveston, Texas, 77555, United States
University of Utah Health

Salt Lake City, Utah, 84132, United States
University of Vermont (UVM) Children's Hospital

Burlington, Vermont, 05401, United States
Virginia Commonwealth University

Richmond, Virginia, 23284, United States
WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States
West Virginia University

Morgantown, West Virginia, 26506, United States
Women & Infants Hospital

Providence, Rhode Island, 02905, United States
Yale School of Medicine (YSM)

New Haven, Connecticut, 06510, United States

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