Pediatric COVID-19 and MIS-C Long-term Follow-up

  • STATUS
    Recruiting
  • End date
    Jul 1, 2027
  • participants needed
    5000
  • sponsor
    Children's National Research Institute
Updated on 30 September 2021

Summary

This is a multisite prospective observational study to evaluate the clinical sequelae of symptomatic and asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the pediatric population, including coronavirus disease 2019 (COVID-19) and multisystem inflammatory syndrome in children (MIS-C), and characterize the immune response associated with these clinical presentations. Participants aged 21 years and younger with laboratory confirmed history of symptomatic or asymptomatic SARS-CoV-2 infection will visit the study sites for clinical and research evaluations and sample collection at schedules dependent on time since infection. Participants enrolled within 12 weeks after acute infection or positive test will be part of the "recovery group" and will attend study visits at baseline, every 3 months for the first 6 months, and subsequently every 6 months for a total of 3 years. Participants enrolled more than 12 weeks after acute infection or positive test will be in the "convalescent group" and will attend study visits at baseline and subsequently every 6 months for a total of 3 years.

Household contacts (aged 21 years) of the infected participants will serve as a control group and will attend visits for evaluations and sample collection at baseline and every 12 months for a total of 3 years. This protocol will establish a cohort of pediatric patients recovered from SARS CoV-2 infection and a biorepository for evaluation of the potential roles of host genetics, immune response, and other possible factors influencing long-term outcomes.

Parents or guardians of participants in all cohorts will also be enrolled for limited participation to complete questionnaires about how the family is impacted by the participant's health and SARS-CoV-2.

Description

This study will establish a cohort of surviving pediatric patients with symptomatic (including COVID-19 and MIS-C) and asymptomatic SARS-CoV-2 infection to study the long-term sequelae of acute infection and the evolution of the immune response over time. Longitudinal follow-up of this cohort will provide important information about clinical sequelae of acute COVID-19 and MIS-C, characteristics of the immune response to SARS-CoV-2, genetic factors associated with long-term outcomes, and the extent and duration of protective immunity.

The study procedures include:

  1. Non-contrast chest computed tomography (CT) or chest X-ray: All participants will undergo 2 chest imaging procedures, one at baseline and one at the final study visit (year 3).
  2. Non-contrast cardiac magnetic resonance imaging (MRI): All participants will undergo 2 to 3 non-contrast cardiac MRI procedures during this study.
  3. Echocardiogram
  4. Electrocardiography (EKG)
  5. Pulmonary Function Test (PFT)
  6. Questionnaires: To complete the questionnaires will take approximately 25 to 64 minutes.
  7. Collection of blood (including for optional genetic testing), nasopharyngeal (NP) swab, urine, and stool.

Genetic testing (optional): This protocol involves genetic testing using whole genome sequencing (WGS) approaches for all participants.

Clinical photography (optional): Participants may decline photographs or place any restrictions on their use.

Details
Condition COVID19, MIS-C Associated With COVID-19, MIS-C Multisystem Inflammatory Syndrome in Children, SARS-CoV2 Infection, MIS-C Associated With COVID-19, MIS-C Multisystem Inflammatory Syndrome in Children, SARS-CoV2 Infection, MIS-C Associated With COVID-19, MIS-C Multisystem Inflammatory Syndrome in Children, SARS-CoV2 Infection, MIS-C Associated With COVID-19, MIS-C Associated With COVID-19, MIS-C Multisystem Inflammatory Syndrome in Children, MIS-C Multisystem Inflammatory Syndrome in Children, SARS-CoV2 Infection, SARS-CoV2 Infection
Clinical Study IdentifierNCT04830852
SponsorChildren's National Research Institute
Last Modified on30 September 2021

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note