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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04588363
Other study ID # DAIT PRISM-01
Secondary ID NIAID CRMS ID#:
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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