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NCT04830852 · ClinicalTrials.gov registry record
Pediatric COVID Outcomes Study (PECOS)
A clinical trial of COVID-19 and SARS CoV 2 Infection, sponsored by Children's National Research Institute.
- Active
- Registry status
- 5,000
- Enrollment target
- 2
- Study locations
NCT04830852: Active study of COVID-19 and SARS CoV 2 Infection, sponsored by Children's National Research Institute.
NCT04830852 is a study of COVID-19 and SARS CoV 2 Infection that is active but no longer recruiting, run by Children's National Research Institute. The registered enrollment target is 5,000 participants, below the 38,448-participant average among 298 other COVID-19 trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04830852, a study of COVID-19 and SARS CoV 2 Infection, is active but no longer recruiting, sponsored by Children's National Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- 5,000 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Incidence and prevalence of medical sequelae among symptomatic SARS-CoV-2 infection survivors, asymptomatic SARS CoV 2 infection survivors, and MIS-C survivors.
Conditions Studied
Study Locations (2)
District of Columbia
- Children's National Hospital - Washington D.C.
Maryland
- National Institutes of Health (NIH) / National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 2021-07-23 |
| Est. Completion | 2027-07-01 |
What the registry record for NCT04830852 still lists
NCT04830852 is an observational study that tracks outcomes without assigning an intervention. Its 5,000 participants enrollment target places it among the larger protocols in the corpus, below the 38,448-participant average among 298 other COVID-19 trials with a reported enrollment target (87% lower).
The record links to 4 conditions, with COVID-19 appearing as the primary indexed condition, and to 0 interventions.
NCT04830852 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT04830852 about?
NCT04830852 is a clinical study titled "Pediatric COVID Outcomes Study (PECOS)". 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 syndrom...
What is the current status of trial NCT04830852?
This trial is currently active not recruiting. The enrollment target is 5,000 participants. The study started on 2021-07-23. Estimated completion is 2027-07-01.
What conditions does trial NCT04830852 study?
This clinical trial studies the following conditions: COVID-19, SARS CoV 2 Infection, MIS-C Associated with COVID-19, MIS-C Multisystem Inflammatory Syndrome in Children.
Who is sponsoring clinical trial NCT04830852?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04830852 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04830852's enrollment target sits among peer trials
5,000 29th of 298 higher than 270 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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