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Status:

ACTIVE_NOT_RECRUITING

Pediatric COVID Outcomes Study (PECOS)

Lead Sponsor:

Children's National Research Institute

Collaborating Sponsors:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Covid19

MIS-C Associated with COVID-19

Eligibility:

All Genders

Up to 21 years

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 pedi...

Detailed 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 infect...

Eligibility Criteria

Inclusion

  • 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:
  • detection of SARS-CoV-2 RNA or antigen in NP swab, saliva, sputum, or other sample source with EUA/approval from the FDA without 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 without history of clinical manifestation compatible with COVID-19\*.
  • Positive SARS-CoV-2 RNA or antigen test 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.
  • Healthy contact (control) cohort:
  • 1\. No diagnosis of SARS-CoV-2 infection or current symptoms suggestive of COVID-19 and meets one of the following criteria:
  • Lived in the same household as a participant with SARS-CoV-2 infection during the time of illness, or was within approximately 6 feet (2 meters) of the participant for a prolonged period of time, or having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).
  • Lives in an area affected by SARS-CoV-2 infection
  • Parents and guardians:
  • In order to participate in this study as a parent or guardian, an individual must meet all of the following criteria:
  • Is a parent or guardian of a participant enrolled as a survivor or as a control.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Willing to allow storage of data for future research.

Exclusion

  • 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:
  • 1\. 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.

Key Trial Info

Start Date :

July 23 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

July 1 2027

Estimated Enrollment :

5000 Patients enrolled

Trial Details

Trial ID

NCT04830852

Start Date

July 23 2021

End Date

July 1 2027

Last Update

February 12 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Children's National Hospital

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

2

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

Bethesda, Maryland, United States, 20852