Pediatric COVID Outcomes Study (PECOS)

NCT04830852 | Active Not Recruiting

• 2 other identifiers: Pro0001551021X125F1
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Covid19; MIS-C Associated with COVID-19; MIS-C Multisystem Inflammatory Syndrome in Children; SARS-CoV2 Infection

Keywords

SARS-CoV-2; COVID-19; MIS-C; Post-COVID; Long-term effects; Pediatric; Children

Outcome Measures

Primary Outcomes (2)

• Incidence and prevalence of medical sequelae, study procedures analysis

  Incidence and prevalence of medical sequelae among symptomatic SARS-CoV-2 infection survivors, asymptomatic SARS CoV 2 infection survivors, and MIS-C survivors.

  6 years

• Risk factors for medical sequelae, study procedures analysis

  Risk factors for medical sequelae among symptomatic SARS CoV 2 infection survivors, asymptomatic SARS-CoV-2 infection survivors, and MIS-C survivors.

  6 years

Secondary Outcomes (3)

• Quality of life and social impact, study procedures analysis

  6 years

• Incidence and prevalence of reinfection, study procedures analysis

  6 years

• Biorepository, study procedures analysis

  6 years

Study Arms (4)

Recovery Group

Participants aged 21 years and younger and enrolled within 12 weeks after acute infection or positive test. These participants 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.

Convalescent Group

Participants aged 21 years and younger and enrolled more than 12 weeks after acute infection or positive test. These participants will attend study visits at baseline and subsequently every 6 months for a total of 3 years.

Healthy contacts

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.

Parents/guardians of participants

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.

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 0 to 21 years with confirmed history of symptomatic SARS CoV-2 infection (including COVID-19), MIS C, or asymptomatic SARS CoV-2 infection (n = up to 1000), as well as healthy contacts (aged ≤21 years; n = up to 1000). Additionally, a parent or guardian of each participant will be enrolled to complete targeted questionnaires (n = up to 2000). Accrual ceiling is 5000 patients.

You may qualify if:

• Survivors and control cohorts:
• In order to be eligible to participate in this study as a survivor or as a control, an individual must meet all of the following criteria:
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female aged 0 to 21 years (at the NIH CC, minimum age is 3 years).
• Willing to allow storage of samples and data for future research.
• At the NIH CC: Has a physician or clinic outside NIH to manage underlying medical conditions, or agrees to establish care with an outside physician or clinic for any medical conditions requiring treatment that may be diagnosed as a result of protocol participation.
• In addition, an individual must meet all criteria for one of the following cohorts.
• Symptomatic survivor cohort (including MIS-C):
• Documented prior COVID-19 or MIS-C as evidenced by one of the following:
• detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other sample source with Emergency Use Authorization (EUA)/approval from the US Food and Drug Administration (FDA) and a history of clinical manifestation compatible with COVID-19\*; or
• positive SARS-CoV-2 antibody test using an assay that has received EUA from the FDA (negative SARS-CoV-2 RNA or antigen or never tested), and a history of clinical manifestation compatible with COVID-19\*; or
• meeting CDC case definition for MIS-C (see Appendix 1).
• Onset of COVID-19/MIS-C symptoms is at least 4 weeks before baseline visit. \*one or more of the following: ageusia, anosmia, chills, confusion, cough, rash, "COVID toes", diarrhea, dyspnea, fatigue, fever, headache, myalgia, nausea/vomiting, pneumonia, rhinorrhea.
• Asymptomatic survivor cohort:
• Documented prior SARS-CoV-2 infection as evidenced by one of the following:

You may not qualify if:

• Survivors and controls:
• An individual who meets any of the following criteria will be excluded from participation in this study:
• Any symptoms suggestive of an ongoing infection within 15 days of baseline visit, including but not limited to fever \> 38.2 °C, new or worsening respiratory symptoms (e.g., cough, dyspnea), or new or worsening gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea or abdominal pain).
• Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study.
• Pregnancy.
• Parents and guardians:
• An individual who meets any of the following criteria will be excluded from participation in this study:
• \. Any medical or mental health condition that, in the judgement of the principal investigator, would make the volunteer unable to participate in the study.
• Co-enrollment: Participants may be co-enrolled in other clinical studies, including observational studies and therapeutic trials. However, the study staff should be informed of co-enrollment.

Sponsors & Collaborators

• Children's National Research Institute: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

National Institutes of Health (NIH) / National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, 20852, United States

Location

Related Links

• If you are interested in participating in this study, please complete this form. A study team member will contact you with additional information.

Biospecimen

Retention: SAMPLES WITH DNA

Blood, nasopharyngeal swab, stool and urine.

MeSH Terms

Conditions

COVID-19; pediatric multisystem inflammatory disease, COVID-19 related

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Roberta DeBiasi, MD, MS

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

• Gina A. Montealegre Sanchez, MD, MS

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MS, Division Chief, Infectious Diseases, Co-Director of the Congenital Zika Program

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: July 23, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 12, 2025

Record last verified: 2024-12

Locations

US (2)