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.
* 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.
Brief Title
COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C
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).
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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Multisystem Inflammatory Syndrome in Children (MIS-C)
Coronavirus Disease 2019 (COVID-19)
Eligibility 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.
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.
Inclusion 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.
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.
Gender
All
Gender Based
false
Keywords
participants <21 years of age
observational cohort study
immunological responses post infection
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
20 Years
NCT Id
NCT04588363
Org Class
Nih
Org Full Name
National Institute of Allergy and Infectious Diseases (NIAID)
Org Study Id
DAIT PRISM-01
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
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)
Primary Outcomes
Outcome Description
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).
Outcome Measure
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
Outcome Time Frame
6 Months Post Illness Presentation (Enrollment)
Secondary Ids
Secondary Id
NIAID CRMS ID#: 38772
Secondary Outcomes
Outcome Description
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).
Outcome Time Frame
1 Year Post Illness Presentation (Enrollment)
Outcome Measure
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
Outcome Description
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).
Outcome Time Frame
1 Year Post Illness Presentation (Enrollment)
Outcome Measure
All-Cause Mortality
Outcome Description
The occurrence of SARS-CoV-2 related death in participants.
Outcome Time Frame
1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Mortality
Outcome Description
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)
* 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)
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Hospitalization for Participants Enrolled as an Outpatient or Rehospitalization after First Admission in Hospitalized Participants
Outcome Description
Characterization of dysregulation involving the coagulation system by D-dimer laboratory test.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Coagulation Abnormality by D-Dimer Biomarker
Outcome Description
Characterization of dysregulation involving the coagulation system by fibrinogen laboratory test.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Coagulation Abnormality by Fibrinogen Biomarker
Outcome Description
Characterization of dysregulation involving the coagulation system by PT and PTT laboratory tests.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Coagulation Abnormality by Prothrombin Time (PT) and Activated Partial Thromboplastin Time (PTT) Biomarkers
Outcome Description
Characterization of dysregulation involving the coagulation system by INR laboratory test.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Coagulation Abnormality by International Normalised Ratio (INR) Biomarker
Outcome Description
Characterization of coronary artery abnormalities (e.g., by echocardiogram and, if performed for clinical indications, angiogram, as examples).
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Coronary Artery Abnormalities
Outcome Description
Prevalence of pulmonary hypertension by echocardiogram and standard of care assessments.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Pulmonary Hypertension
Outcome Description
Characterization of cardiovascular system dysregulation by BNP laboratory test.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Cardiovascular System Dysregulation by B-type natriuretic peptide (BNP) Biomarker
Outcome Description
Characterization of cardiovascular system dysregulation by Troponin I laboratory test.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Cardiovascular System Dysregulation by Troponin I Biomarker
Outcome Description
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.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Cardiovascular System Dysregulation by Echocardiogram
Outcome Description
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.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Cardiovascular System Dysregulation by Electrocardiogram (ECG)
Outcome Description
Pulmonary fibrosis (i.e., scarring) or other abnormalities detected by computerized tomography (CT) imaging.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Pulmonary Abnormalities
Outcome Description
Characterization by pulmonary function tests (spirometry without bronchodilators).
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Pulmonary Function Characteristics
Outcome Description
Characterization of kidney/metabolic function by serum creatinine and blood urea nitrogen (BUN) laboratory tests
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Renal/Metabolic Biomarkers: Serum Creatinine and Blood Urea Nitrogen (BUN)
Outcome Description
Characterization of kidney/metabolic function by the estimated glomerular filtration rate (eGFR) calculated value, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Renal/Metabolic Biomarker: Estimated glomerular filtration rate (eGFR)
Outcome Description
Characterization of liver/metabolic function by the following laboratory tests:
* alkaline phosphatase
* alanine aminotransferase (ALT/SGPT) and
* aspartate aminotransferase (AST/SGOT).
* alkaline phosphatase
* alanine aminotransferase (ALT/SGPT) and
* aspartate aminotransferase (AST/SGOT).
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Hepatic/Metabolic Biomarkers: Serum Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase ( ALT/SGPT)and Aspartate Aminotransferase (AST/SGOT)
Outcome Description
Characterization of liver/metabolic function by serum total bilirubin laboratory test.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Hepatic/Metabolic Biomarker: Total Bilirubin
Outcome Description
Characterization of neurologic sequelae of infection/disease.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Neurologic Abnormalities
Outcome Description
Identified by and characterized during standard of care assessments.
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
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)
Outcome Description
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).
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).
Outcome Time Frame
Up to 1 Year Post Illness Presentation (Enrollment)
Outcome Measure
Health Related Quality of Life
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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
* 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
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
20
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nadine Choueiter
Investigator Email
nchoueit@montefiore.org
Investigator Phone
718-741-2343
Categories Mesh Debug
COVID-19 --- COVID-19
COVID-19 --- PNEUMONIA, VIRAL
COVID-19 --- PNEUMONIA
Lung --- PNEUMONIA
COVID-19 --- RESPIRATORY TRACT INFECTIONS
Lung --- RESPIRATORY TRACT INFECTIONS
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
COVID-19 --- VIRUS DISEASES
Hepatitis --- VIRUS DISEASES
Infectious Disease --- VIRUS DISEASES
COVID-19 --- CORONAVIRUS INFECTIONS
COVID-19 --- CORONAVIRIDAE INFECTIONS
COVID-19 --- NIDOVIRALES INFECTIONS
COVID-19 --- RNA VIRUS INFECTIONS
Infectious Disease --- RNA VIRUS INFECTIONS
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
MeSH Terms
PEDIATRIC MULTISYSTEM INFLAMMATORY DISEASE, COVID-19 RELATED
COVID-19
PNEUMONIA, VIRAL
PNEUMONIA
RESPIRATORY TRACT INFECTIONS
INFECTIONS
VIRUS DISEASES
CORONAVIRUS INFECTIONS
CORONAVIRIDAE INFECTIONS
NIDOVIRALES INFECTIONS
RNA VIRUS INFECTIONS
LUNG DISEASES
RESPIRATORY TRACT DISEASES