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Pediatric COVID Outcomes Study (PECOS)

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Children's National Research Institute to Children's National Research Institute Trial completed · Final enrollment: 1097 participants (planned 5000) · Primary completion date changed from estimate of Jul 1, 2027 to Feb 27, 2026 · 5 more Show 8 more changesShow less
    • Trial completed
    • Final enrollment: 1097 participants (planned 5000)
    • Primary completion date changed from estimate of Jul 1, 2027 to Feb 27, 2026
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description expanded, about 7 words
    • Site details revised at 2 of 2 sites
    • Publications: 2 to 5
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Recruiting to Active, Not Recruiting Site details revised at 2 of 2 sitesv6 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  4. Re-verified, no change to tracked fieldsv5
  5. Eligibility criteria expanded, about 20 words Study title shortened, about 1 wordv4 Show 1 more changeShow less
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Start date changed from estimate of Jul 19, 2021 to Jul 23, 2021 Study sites revised (2)v3 Show 1 more changeShow less
    • Study sites revised (2)

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: May 1, 2024 to Jul 1, 2027 · Start date: May 1, 2021 to Jul 19, 2021 · Primary endpoints revised (2) · 5 morev2 Show 8 more changesShow less
    • Primary completion date: May 1, 2024 to Jul 1, 2027
    • Start date: May 1, 2021 to Jul 19, 2021
    • Primary endpoints revised (2)
    • Study sites: 0 to 2
    • Completion date: May 1, 2027 to Jul 1, 2027
    • Secondary endpoints revised (3)
    • Study description shortened, about 849 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04830852
Lead Sponsor Children's National Research Institute
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Covid19, MIS-C Associated With COVID-19, MIS-C Multisystem Inflammatory Syndrome in Children, SARS-CoV2 Infection
Enrollment 1,097 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov