Pediatric COVID Outcomes Study (PECOS)

Covid19 Clinical Trial

Official title: Pediatric SARS-CoV-2 and MIS-C Long-term Follow-up

Status Active, not recruiting

Clinical Trial 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.

Individuals (aged ≤21 years) without a diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV2 Infection

• NCT number: NCT04830852
• Study type: Observational
• Source: Children's National Research Institute
• Status: Active, not recruiting
• Start date: July 23, 2021
• Completion date: July 1, 2027