Long-term Impact Study for COVID-19 in Children

Not currently recruiting at 79 trial locations
HA
SK
Overseen ByStuart Katz, MD, MS
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how COVID-19 affects children and young adults over time, focusing on those with long-term symptoms, often called "long COVID." Researchers will observe both individuals who have had COVID-19 and those who haven't to identify risk factors and occurrences of post-acute sequelae of SARS-CoV-2 (PASC), which are ongoing symptoms after the initial infection. Participants may include children or young adults aged 0-25 who have had COVID-19 in the past two years, have been exposed to the virus, or live in areas with high transmission. This includes those with frequent COVID-19 symptoms or those who have been vaccinated. The study will collect health data and biological samples to track the virus's long-term health impacts. As an unphased study, this trial offers participants a chance to contribute to vital research that could improve understanding and treatment of long COVID in young populations.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover the long-term effects of COVID-19 on children and families. Unlike immediate treatment options that focus on symptom management or virus mitigation, this observational study seeks to understand the broader, lasting impacts of the virus. By identifying these long-term effects, the study could potentially guide future healthcare strategies and interventions, ensuring better mental, physical, and social health outcomes for children and their families in the post-pandemic world.

Who Is on the Research Team?

LH

Leora Horwitz, MD

Principal Investigator

NYU Langone Health

SK

Stuart Katz, MD, MS

Principal Investigator

NYU Langone Health

AT

Andrea Troxel, ScD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Inclusion 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
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial data collection including demographics, medical history, and SARS-CoV-2 infection status

Baseline
1 visit (in-person or remote)

Longitudinal Follow-up

Participants are monitored for symptoms and changes in health status over time

48 months
Regular intervals (in-person or remote)

Biologic Specimen Collection

Collection of biologic specimens at specified intervals for analysis

Throughout study

What Are the Treatments Tested in This Trial?

Interventions

  • Observational Study

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+
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