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| ID | Type | Description | Link |
|---|---|---|---|
| NIAID CRMS ID#: 38772 | Other Identifier | DAIT NIAID |
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| Name | Class |
|---|---|
| Autoimmunity Centers of Excellence | OTHER |
| Clinical Trials in Organ Transplantation in Children | OTHER |
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The primary objectives of this study are:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-CoV-2 positive children | Individuals less than 21 years of age who fulfill one or more of the following criteria:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 and/or MIS-C Exposure | Other | This is an observational cohort study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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.
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Individuals less than 21 years of age who fulfill one or more of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Principal Investigator |
| Natasha B Halasa, MD, MPH | Department of Pediatrics, Vanderbilt University Medical Center | Principal Investigator |
| Virginia Pascual, MD | Gale and Ira Drukier Institute for Children's Health, Weill Cornell Medicine | Principal Investigator |
| Betty Diamond, MD | Institute of Molecular Medicine, The Feinstein Institute for Medical Research | Principal Investigator |
| Ignacio Sanz, MD | Division of Rheumatology, Emory University | Principal Investigator |
| Olivia Martinez, PhD | Stanford University | Principal Investigator |
| Sheri Krams, PhD | Stanford University | Principal Investigator |
| Jeremy Boss, PhD | Emory University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Health | Loma Linda | California | 92354 | United States | ||
| Cedars-Sinai Medical Center |
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| Label | URL |
|---|---|
| Clinical Trials in Organ Transplantation in Children | View source |
| Division of Allergy, Immunology and Transplantation | View source |
| National Institute of Allergy and Infection Diseases |
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Blood, Nasal Swabs, Saliva, Stools, Urine
| 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). | 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. | 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:
Abbreviations:
| 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. | Up to 1 Year Post Illness Presentation (Enrollment) |
| Coagulation Abnormality by Fibrinogen Biomarker | Characterization of dysregulation involving the coagulation system by fibrinogen laboratory test. | 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. | 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. | 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). | Up to 1 Year Post Illness Presentation (Enrollment) |
| Pulmonary Hypertension | Prevalence of pulmonary hypertension by echocardiogram and standard of care assessments. | 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. | 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. | 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. | 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. | Up to 1 Year Post Illness Presentation (Enrollment) |
| Pulmonary Abnormalities | Pulmonary fibrosis (i.e., scarring) or other abnormalities detected by computerized tomography (CT) imaging. | Up to 1 Year Post Illness Presentation (Enrollment) |
| Pulmonary Function Characteristics | Characterization by pulmonary function tests (spirometry without bronchodilators). | 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 | 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. | 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:
| Up to 1 Year Post Illness Presentation (Enrollment) |
| Hepatic/Metabolic Biomarker: Total Bilirubin | Characterization of liver/metabolic function by serum total bilirubin laboratory test. | Up to 1 Year Post Illness Presentation (Enrollment) |
| Neurologic Abnormalities | Characterization of neurologic sequelae of infection/disease. | 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. | 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). | Up to 1 Year Post Illness Presentation (Enrollment) |
| Principal Investigator |
| Los Angeles |
| California |
| 90048 |
| United States |
| Children's Hospital Los Angeles | Los Angeles | California | 91011 | United States |
| Lucile Packard Children's Hospital Stanford | Palo Alto | California | 94303 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| NewYork-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | United States |
| NewYork-Presbyterian Queens Hospital | Flushing | New York | 11355 | United States |
| Cohen Children's Medical Center - Northwell Health | New Hyde Park | New York | 11040 | United States |
| Hassenfeld Children's Hospital at NYU Langone | New York | New York | 10016 | United States |
| NewYork-Presbyterian Komansky Children's Hospital | New York | New York | 10021 | United States |
| Mount Sinai Kravis Children's Hospital | New York | New York | 10029 | United States |
| Children's Hospital at Montefiore | The Bronx | New York | 10467 | United States |
| Duke University Children's Health Center | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Medical University of South Carolina, Pediatric Rheumatology | Charleston | South Carolina | 29425 | United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
| ID | Term |
|---|---|
| C000705967 | pediatric multisystem inflammatory disease, COVID-19 related |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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