COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C

NCT04588363 | Completed

• 2 other identifiers: DAIT PRISM-01NIAID CRMS ID#: 38772
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 20

Brief Summary

The primary objectives of this study are:

• To determine the proportion of children with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) related death, rehospitalization or major complications after infection with SARS-CoV-2 and/or Multisystem Inflammatory Syndrome in Children (MIS-C), and
• To determine immunologic mechanisms and immune signatures associated with disease spectrum and subsequent clinical course during the year of follow-up.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); Multisystem Inflammatory Syndrome in Children (MIS-C); Coronavirus Disease 2019 (COVID-19)

Keywords

participants <21 years of age; observational cohort study; immunological responses post infection

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Either COVID-19-Related Death, Rehospitalization, Major Complications after SARS-CoV-2 Illness and/or MIS-C at 6 Months Post Illness Presentation

  Participants who experience Coronavirus Disease 2019 (COVID-19)-related death, rehospitalization or major complications after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) illness and/or multisystem inflammatory syndrome in children (MIS-C).

  6 Months Post Illness Presentation (Enrollment)

Secondary Outcomes (23)

• Proportion of Participants with Coronavirus Disease 2019 (COVID-19)-Related Death after Multisystem Inflammatory Syndrome in Children (MIS-C) at 1 Year Post Illness Presentation

  1 Year Post Illness Presentation (Enrollment)

• All-Cause Mortality

  1 Year Post Illness Presentation (Enrollment)

• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Mortality

  1 Year Post Illness Presentation (Enrollment)

• Hospitalization for Participants Enrolled as an Outpatient or Rehospitalization after First Admission in Hospitalized Participants

  Up to 1 Year Post Illness Presentation (Enrollment)

• Coagulation Abnormality by D-Dimer Biomarker

  Up to 1 Year Post Illness Presentation (Enrollment)

Study Arms (1)

SARS-CoV-2 positive children

Individuals less than 21 years of age who fulfill one or more of the following criteria: * SARS-CoV-2 detection from a respiratory specimen, and/or * Meets criteria for MIS-C, and/or * Meets criteria for MIS-C, except has involvement of only 1 organ system

Other: SARS-CoV-2 and/or MIS-C Exposure

Interventions

SARS-CoV-2 and/or MIS-C Exposure OTHER

This is an observational cohort study.

Also known as: Exposure: Severe Acute Respiratory Syndrome Coronavirus 2 Infection and/or Multisystem Inflammatory Syndrome in Children diagnosis

SARS-CoV-2 positive children

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals less than 21 years of age who fulfill one or more of the following criteria: * SARS-CoV-2 detection from a respiratory specimen, and/or * Meets criteria for MIS-C, and/or * Meets criteria for MIS-C, except has involvement of only 1 organ system

You may qualify if:

• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) detection from a respiratory specimen, and/or
• Meets criteria for Multisystem Inflammatory Syndrome in Children (MIS-C), and/or
• Meets criteria for MIS-C, except has involvement of only 1 organ system
• Cases meeting clinical criteria for MIS-C but without known SARS-CoV-2 exposure, and who are being treated as MIS-C by the treating physician, but with negative SARS-CoV-2 PCR and pending or negative antibody testing, may be enrolled as subjects. If subsequent antibody testing is positive, cases will be labelled as confirmed MIS-C. If SARS-CoV-2 antibody testing is negative, subjects will be labeled at the end of the study as suspected/not confirmed MIS-C.

You may not qualify if:

• \. Subject and/or parent/guardian who are not able to understand or be willing to provide informed consent and where applicable assent

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Autoimmunity Centers of Excellence: collaborator
• Clinical Trials in Organ Transplantation in Children: collaborator

Study Sites (20)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 91011, United States

Location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94303, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

NewYork-Presbyterian Queens Hospital

Flushing, New York, 11355, United States

Location

Cohen Children's Medical Center - Northwell Health

New Hyde Park, New York, 11040, United States

Location

Hassenfeld Children's Hospital at NYU Langone

New York, New York, 10016, United States

Location

NewYork-Presbyterian Komansky Children's Hospital

New York, New York, 10021, United States

Location

Mount Sinai Kravis Children's Hospital

New York, New York, 10029, United States

Location

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

Duke University Children's Health Center

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina, Pediatric Rheumatology

Charleston, South Carolina, 29425, United States

Location

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Related Links

• Clinical Trials in Organ Transplantation in Children
• Division of Allergy, Immunology and Transplantation
• National Institute of Allergy and Infection Diseases

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Nasal Swabs, Saliva, Stools, Urine

MeSH Terms

Conditions

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

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

• Steven A. Webber, MBChB, MRCP

  Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt

  STUDY CHAIR

• James D. Wilkinson, MD, MPH

  Vanderbilt Institute for Clinical and Translational Research (VICTR)

  PRINCIPAL INVESTIGATOR

• Natasha B Halasa, MD, MPH

  Department of Pediatrics, Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Virginia Pascual, MD

  Gale and Ira Drukier Institute for Children's Health, Weill Cornell Medicine

  PRINCIPAL INVESTIGATOR

• Betty Diamond, MD

  Institute of Molecular Medicine, The Feinstein Institute for Medical Research

  PRINCIPAL INVESTIGATOR

• Ignacio Sanz, MD

  Division of Rheumatology, Emory University

  PRINCIPAL INVESTIGATOR

• Olivia Martinez, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Sheri Krams, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Jeremy Boss, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 19, 2020
• Study Start: November 19, 2020
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

US (20)