Skip to main content
OpenTrials
Completed

NCT Number: NCT04588363

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) COVID-19 Coronaviridae Infections Coronavirus Disease 2019 (COVID-19) Coronavirus Infections Infections Lung Diseases Multisystem Inflammatory Syndrome in Children (MIS-C) Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases pediatric multisystem inflammatory disease, COVID-19 related

Age range

Up to 20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University Health, Loma Linda, California, United States

Loading trial locations.

About this study

This is a prospective, multicenter, observational cohort study to assess short and long-term clinical outcomes and immune responses after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection and/or Multisystem Inflammatory Syndrome in Children (MIS-C) in children (e.g., defined as individuals who have not reached their 21st birthday at the time of enrollment). SARS-CoV-2 causes Coronavirus Disease 2019 (COVID-19)

Participants will be identified through active recruitment measures within hospitals and through ambulatory and laboratory-based databases of SARS-CoV-2 positive individuals <21 years of age. The study will enroll a minimum of 250 subjects from a diverse racial/ethnic background, from participating medical centers in the United States. The study period of participation is 1 year (12 months).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

--Note, for this observational cohort study, participation in other COVID-19 studies is not an automatic exclusionary criterion.

Treatment and study plan

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

Other

This is an observational cohort study.

Other names: Exposure: Severe Acute Respiratory Syndrome Coronavirus 2 Infection and/or Multisystem Inflammatory Syndrome in Children diagnosis

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

    Time frame: 6 Months Post Illness Presentation (Enrollment)

    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).

Secondary outcomes

  1. 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

    Time frame: 1 Year Post Illness Presentation (Enrollment)

    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).

  2. All-Cause Mortality

    Time frame: 1 Year Post Illness Presentation (Enrollment)

    The occurrence of death in participants regardless of relationship to Coronavirus Disease 2019 (COVID-19) and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).

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

    Time frame: 1 Year Post Illness Presentation (Enrollment)

    The occurrence of SARS-CoV-2 related death in participants.

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

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of Participants who require:

    • Hospitalization subsequent to enrollment as an outpatient for SARS-CoV-2/COVID-19 related illness and/or MIS-C, or
    • Rehospitalization after discharge from their initial admission for SARS-CoV-2/COVID-19 related illness and/or MIS-C.

    Abbreviations:

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

  5. Coagulation Abnormality by D-Dimer Biomarker

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of dysregulation involving the coagulation system by D-dimer laboratory test.

  6. Coagulation Abnormality by Fibrinogen Biomarker

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of dysregulation involving the coagulation system by fibrinogen laboratory test.

  7. Coagulation Abnormality by Prothrombin Time (PT) and Activated Partial Thromboplastin Time (PTT) Biomarkers

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of dysregulation involving the coagulation system by PT and PTT laboratory tests.

  8. Coagulation Abnormality by International Normalised Ratio (INR) Biomarker

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of dysregulation involving the coagulation system by INR laboratory test.

  9. Coronary Artery Abnormalities

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of coronary artery abnormalities (e.g., by echocardiogram and, if performed for clinical indications, angiogram, as examples).

  10. Pulmonary Hypertension

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Prevalence of pulmonary hypertension by echocardiogram and standard of care assessments.

  11. Cardiovascular System Dysregulation by B-type natriuretic peptide (BNP) Biomarker

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of cardiovascular system dysregulation by BNP laboratory test.

  12. Cardiovascular System Dysregulation by Troponin I Biomarker

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of cardiovascular system dysregulation by Troponin I laboratory test.

  13. Cardiovascular System Dysregulation by Echocardiogram

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of cardiac function by echocardiogram (Echo), a test that uses high frequency sound waves (ultrasound) to make pictures of the heart. The test is also referred to as a diagnostic cardiac ultrasound.

  14. Cardiovascular System Dysregulation by Electrocardiogram (ECG)

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of cardiovascular system dysregulation(s) evaluated by standardized 12-lead electrocardiogram. ECG rhythms, intervals and voltages will be assessed. Cross reference: ECG and EKG are used interchangeably.

  15. Pulmonary Abnormalities

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Pulmonary fibrosis (i.e., scarring) or other abnormalities detected by computerized tomography (CT) imaging.

  16. Pulmonary Function Characteristics

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization by pulmonary function tests (spirometry without bronchodilators).

  17. Renal/Metabolic Biomarkers: Serum Creatinine and Blood Urea Nitrogen (BUN)

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of kidney/metabolic function by serum creatinine and blood urea nitrogen (BUN) laboratory tests

  18. Renal/Metabolic Biomarker: Estimated glomerular filtration rate (eGFR)

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of kidney/metabolic function by the estimated glomerular filtration rate (eGFR) calculated value, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.

  19. Hepatic/Metabolic Biomarkers: Serum Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase ( ALT/SGPT)and Aspartate Aminotransferase (AST/SGOT)

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of liver/metabolic function by the following laboratory tests:

    • alkaline phosphatase
    • alanine aminotransferase (ALT/SGPT) and
    • aspartate aminotransferase (AST/SGOT).

  20. Hepatic/Metabolic Biomarker: Total Bilirubin

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of liver/metabolic function by serum total bilirubin laboratory test.

  21. Neurologic Abnormalities

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Characterization of neurologic sequelae of infection/disease.

  22. Other End Organ and/or functional abnormalities Occurring After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection/ Coronavirus Disease 2019 (COVID-19) and/or Multisystem Inflammatory Syndrome in Children (MIS-C)

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Identified by and characterized during standard of care assessments.

  23. Health Related Quality of Life

    Time frame: Up to 1 Year Post Illness Presentation (Enrollment)

    Assessment of health-related quality of life (HRQOL) after Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection/ Coronavirus Disease 2019 (COVID-19) and/or multisystem inflammatory syndrome in children (MIS-C).

    The Pediatric Quality of Life Inventory is a series of assessment instruments designed to measure the health-related quality of life of children. The PedsQL 4.0 provides an opportunity for the assessment of both overall (generic) quality of life as well as disease-specific quality of life.

    The PedsQL 4.0 Generic Core Scales are appropriate for assessing health-related quality of life in both healthy and chronically ill children. The four scales making up this generic battery include Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items).

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Autoimmunity Centers of Excellence
  • Clinical Trials in Organ Transplantation in Children

Registry information

Official study title

An Observational Cohort Study to Determine Late Outcomes and Immunological Responses After Infection With SARS-CoV-2 in Children With and Without Multisystem Inflammatory Syndrome (MIS-C)

Acronym: PRISM

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2020
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.