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

Coronavirus Disease 2019 (COVID-19) Clinical Trial

— PRISM  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04588363
• Other study ID #: DAIT PRISM-01
• Secondary ID: NIAID CRMS ID#:
• Status: Completed
• Start date: November 19, 2020
• Est. completion date: March 3, 2023

Study information

• Verified date: February 2024
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• SARS-CoV-2 and/or MIS-C Exposure
This is an observational cohort study.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Children's Hospital at Montefiore	Bronx	New York
United States	NewYork-Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York
United States	Medical University of South Carolina, Pediatric Rheumatology	Charleston	South Carolina
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Duke University Children's Health Center	Durham	North Carolina
United States	NewYork-Presbyterian Queens Hospital	Flushing	New York
United States	Loma Linda University Health	Loma Linda	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Cohen Children's Medical Center - Northwell Health	New Hyde Park	New York
United States	Hassenfeld Children's Hospital at NYU Langone	New York	New York
United States	Mount Sinai Kravis Children's Hospital	New York	New York
United States	NewYork-Presbyterian Komansky Children's Hospital	New York	New York
United States	Lucile Packard Children's Hospital Stanford	Palo Alto	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	St. Louis Children's Hospital	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence, Clinical Trials in Organ Transplantation in Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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).	1 Year Post Illness Presentation (Enrollment)
Secondary	All-Cause Mortality	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).	1 Year Post Illness Presentation (Enrollment)
Secondary	Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Mortality	The occurrence of SARS-CoV-2 related death in participants.	1 Year Post Illness Presentation (Enrollment)
Secondary	Hospitalization for Participants Enrolled as an Outpatient or Rehospitalization after First Admission in Hospitalized Participants	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)	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Coagulation Abnormality by D-Dimer Biomarker	Characterization of dysregulation involving the coagulation system by D-dimer laboratory test.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Coagulation Abnormality by Fibrinogen Biomarker	Characterization of dysregulation involving the coagulation system by fibrinogen laboratory test.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Coagulation Abnormality by Prothrombin Time (PT) and Activated Partial Thromboplastin Time (PTT) Biomarkers	Characterization of dysregulation involving the coagulation system by PT and PTT laboratory tests.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Coagulation Abnormality by International Normalised Ratio (INR) Biomarker	Characterization of dysregulation involving the coagulation system by INR laboratory test.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Coronary Artery Abnormalities	Characterization of coronary artery abnormalities (e.g., by echocardiogram and, if performed for clinical indications, angiogram, as examples).	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Pulmonary Hypertension	Prevalence of pulmonary hypertension by echocardiogram and standard of care assessments.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Cardiovascular System Dysregulation by B-type natriuretic peptide (BNP) Biomarker	Characterization of cardiovascular system dysregulation by BNP laboratory test.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Cardiovascular System Dysregulation by Troponin I Biomarker	Characterization of cardiovascular system dysregulation by Troponin I laboratory test.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Cardiovascular System Dysregulation by Echocardiogram	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.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Cardiovascular System Dysregulation by Electrocardiogram (ECG)	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.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Pulmonary Abnormalities	Pulmonary fibrosis (i.e., scarring) or other abnormalities detected by computerized tomography (CT) imaging.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Pulmonary Function Characteristics	Characterization by pulmonary function tests (spirometry without bronchodilators).	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Renal/Metabolic Biomarkers: Serum Creatinine and Blood Urea Nitrogen (BUN)	Characterization of kidney/metabolic function by serum creatinine and blood urea nitrogen (BUN) laboratory tests	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Renal/Metabolic Biomarker: Estimated glomerular filtration rate (eGFR)	Characterization of kidney/metabolic function by the estimated glomerular filtration rate (eGFR) calculated value, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Hepatic/Metabolic Biomarkers: Serum Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase ( ALT/SGPT)and Aspartate Aminotransferase (AST/SGOT)	Characterization of liver/metabolic function by the following laboratory tests: alkaline phosphatase; alanine aminotransferase (ALT/SGPT) and; aspartate aminotransferase (AST/SGOT).	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Hepatic/Metabolic Biomarker: Total Bilirubin	Characterization of liver/metabolic function by serum total bilirubin laboratory test.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Neurologic Abnormalities	Characterization of neurologic sequelae of infection/disease.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	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)	Identified by and characterized during standard of care assessments.	Up to 1 Year Post Illness Presentation (Enrollment)
Secondary	Health Related Quality of Life	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).	Up to 1 Year Post Illness Presentation (Enrollment)

External Links

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