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

Running, not enrolling

Conditions studied: SARS-CoV-2 Infection

In brief

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.

Key facts

Study ID

NCT05172011

Run by

NYU Langone Health

People needed

15028

Starts

2022-03-01

Expected to finish

2027-05-23

Last updated by the study team

2025-12-31

Who can join

Age: any, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Infected Cohort:
• Patients will be eligible for inclusion according to the following criteria:
• 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
• 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:
• 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
• 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.
• 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
• An asymptomatic person not meeting epidemiologic criteria with a positive SARS-CoV-2 Antigen-RDT.
• Children/Young Adults with Probable SARS-Cov-2 Infection
• 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
• A suspect case with chest imaging showing findings suggestive of COVID-19 disease; OR
• A person with recent onset of anosmia (loss of smell) or ageusia (loss of taste) in the absence of any other identified cause

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

Where it is running

• 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
• University of Alabama at Birmingham (Pregnancy Cohort) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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