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

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ClinicalTrials.gov Identifier: NCT04588363
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : February 24, 2021
Sponsor:
Collaborators:
Autoimmunity Centers of Excellence
Clinical Trials in Organ Transplantation in Children
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Multisystem Inflammatory Syndrome in Children (MIS-C) Coronavirus Disease 2019 (COVID-19) Other: SARS-CoV-2 and/or MIS-C Exposure

Detailed Description:

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).

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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)
Actual Study Start Date : November 19, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
This is an observational cohort study.
Other Name: Exposure: Severe Acute Respiratory Syndrome Coronavirus 2 Infection and/or Multisystem Inflammatory Syndrome in Children diagnosis




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Biospecimen Retention:   Samples With DNA
Blood, Nasal Swabs, Saliva, Stools, Urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  1. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) detection from a respiratory specimen, and/or
  2. Meets criteria for Multisystem Inflammatory Syndrome in Children (MIS-C), and/or
  3. 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:

1. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588363


Locations
Show Show 24 study locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmunity Centers of Excellence
Clinical Trials in Organ Transplantation in Children
Investigators
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Principal Investigator: 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)
Study Chair: Natasha B Halasa, MD, MPH Department of Pediatrics, Vanderbilt University Medical Center
Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04588363    
Other Study ID Numbers: DAIT PRISM-01
NIAID CRMS ID#: 38772 ( Other Identifier: DAIT NIAID )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
participants <21 years of age
observational cohort study
immunological responses post infection
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Syndrome
Disease
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases