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.
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).
Study Type
OBSERVATIONAL
Enrollment
244
This is an observational cohort study.
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
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
NewYork-Presbyterian Queens Hospital
Flushing, New York, United States
Cohen Children's Medical Center - Northwell Health
New Hyde Park, New York, United States
...and 10 more locations
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).
Time frame: 6 Months Post Illness Presentation (Enrollment)
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).
Time frame: 1 Year Post Illness Presentation (Enrollment)
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).
Time frame: 1 Year Post Illness Presentation (Enrollment)
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Mortality
The occurrence of SARS-CoV-2 related death in participants.
Time frame: 1 Year Post Illness Presentation (Enrollment)
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)
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Coagulation Abnormality by D-Dimer Biomarker
Characterization of dysregulation involving the coagulation system by D-dimer laboratory test.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Coagulation Abnormality by Fibrinogen Biomarker
Characterization of dysregulation involving the coagulation system by fibrinogen laboratory test.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
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.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Coagulation Abnormality by International Normalised Ratio (INR) Biomarker
Characterization of dysregulation involving the coagulation system by INR laboratory test.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Coronary Artery Abnormalities
Characterization of coronary artery abnormalities (e.g., by echocardiogram and, if performed for clinical indications, angiogram, as examples).
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Pulmonary Hypertension
Prevalence of pulmonary hypertension by echocardiogram and standard of care assessments.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Cardiovascular System Dysregulation by B-type natriuretic peptide (BNP) Biomarker
Characterization of cardiovascular system dysregulation by BNP laboratory test.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Cardiovascular System Dysregulation by Troponin I Biomarker
Characterization of cardiovascular system dysregulation by Troponin I laboratory test.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
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.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
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.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Pulmonary Abnormalities
Pulmonary fibrosis (i.e., scarring) or other abnormalities detected by computerized tomography (CT) imaging.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Pulmonary Function Characteristics
Characterization by pulmonary function tests (spirometry without bronchodilators).
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
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
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
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.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
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).
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Hepatic/Metabolic Biomarker: Total Bilirubin
Characterization of liver/metabolic function by serum total bilirubin laboratory test.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
Neurologic Abnormalities
Characterization of neurologic sequelae of infection/disease.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
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.
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
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).
Time frame: Up to 1 Year Post Illness Presentation (Enrollment)
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