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)

National Institute of Allergy and Infectious Diseases (NIAID)20 sites in 1 country244 target enrollmentNovember 19, 2020

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

Overview

Phase: N/A
Intervention: Not specified
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Enrollment: 244
Locations: 20
Primary Endpoint: 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
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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).

Registry

clinicaltrials.gov

Start Date

November 19, 2020

End Date

March 3, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) detection from a respiratory specimen, and/or
•Meets criteria for Multisystem Inflammatory Syndrome in Children (MIS-C), and/or
•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

•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.

Outcomes

Primary Outcomes

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

Time Frame: 6 Months Post Illness Presentation (Enrollment)

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).

Secondary Outcomes

Coagulation Abnormality by Fibrinogen Biomarker(Up to 1 Year Post Illness Presentation (Enrollment))
Cardiovascular System Dysregulation by Electrocardiogram (ECG)(Up to 1 Year Post Illness Presentation (Enrollment))
Hepatic/Metabolic Biomarker: Total Bilirubin(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)(Up to 1 Year Post Illness Presentation (Enrollment))
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Mortality(1 Year Post Illness Presentation (Enrollment))
Coagulation Abnormality by International Normalised Ratio (INR) Biomarker(Up to 1 Year Post Illness Presentation (Enrollment))
Coronary Artery Abnormalities(Up to 1 Year Post Illness Presentation (Enrollment))
All-Cause Mortality(1 Year Post Illness Presentation (Enrollment))
Hospitalization for Participants Enrolled as an Outpatient or Rehospitalization after First Admission in Hospitalized Participants(Up to 1 Year Post Illness Presentation (Enrollment))
Cardiovascular System Dysregulation by Troponin I Biomarker(Up to 1 Year Post Illness Presentation (Enrollment))
Pulmonary Abnormalities(Up to 1 Year Post Illness Presentation (Enrollment))
Pulmonary Function Characteristics(Up to 1 Year 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(1 Year Post Illness Presentation (Enrollment))
Coagulation Abnormality by D-Dimer Biomarker(Up to 1 Year Post Illness Presentation (Enrollment))
Coagulation Abnormality by Prothrombin Time (PT) and Activated Partial Thromboplastin Time (PTT) Biomarkers(Up to 1 Year Post Illness Presentation (Enrollment))
Pulmonary Hypertension(Up to 1 Year Post Illness Presentation (Enrollment))
Cardiovascular System Dysregulation by B-type natriuretic peptide (BNP) Biomarker(Up to 1 Year Post Illness Presentation (Enrollment))
Cardiovascular System Dysregulation by Echocardiogram(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)(Up to 1 Year Post Illness Presentation (Enrollment))
Neurologic Abnormalities(Up to 1 Year Post Illness Presentation (Enrollment))
Renal/Metabolic Biomarkers: Serum Creatinine and Blood Urea Nitrogen (BUN)(Up to 1 Year Post Illness Presentation (Enrollment))
Renal/Metabolic Biomarker: Estimated glomerular filtration rate (eGFR)(Up to 1 Year Post Illness Presentation (Enrollment))
Health Related Quality of Life(Up to 1 Year Post Illness Presentation (Enrollment))