COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C (PRISM)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04588363 |
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Recruitment Status :
Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : September 23, 2022
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Multisystem Inflammatory Syndrome in Children (MIS-C) Coronavirus Disease 2019 (COVID-19) | Other: SARS-CoV-2 and/or MIS-C Exposure |
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 |
| Actual Enrollment : | 244 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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) |
| Actual Study Start Date : | November 19, 2020 |
| Estimated Primary Completion Date : | April 2, 2023 |
| Estimated Study Completion Date : | April 2, 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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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Other: SARS-CoV-2 and/or MIS-C Exposure
This is an observational cohort study.
Other Name: Exposure: Severe Acute Respiratory Syndrome Coronavirus 2 Infection and/or Multisystem Inflammatory Syndrome in Children diagnosis |
- 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).
- 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 [ Time Frame: 1 Year 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).
- All-Cause Mortality [ Time Frame: 1 Year Post Illness Presentation (Enrollment) ]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).
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Mortality [ Time Frame: 1 Year Post Illness Presentation (Enrollment) ]The occurrence of SARS-CoV-2 related death in participants.
- Hospitalization for Participants Enrolled as an Outpatient or Rehospitalization after First Admission in Hospitalized Participants [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]
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)
- Coagulation Abnormality by D-Dimer Biomarker [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Characterization of dysregulation involving the coagulation system by D-dimer laboratory test.
- Coagulation Abnormality by Fibrinogen Biomarker [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Characterization of dysregulation involving the coagulation system by fibrinogen laboratory test.
- Coagulation Abnormality by Prothrombin Time (PT) and Activated Partial Thromboplastin Time (PTT) Biomarkers [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Characterization of dysregulation involving the coagulation system by PT and PTT laboratory tests.
- Coagulation Abnormality by International Normalised Ratio (INR) Biomarker [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Characterization of dysregulation involving the coagulation system by INR laboratory test.
- Coronary Artery Abnormalities [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Characterization of coronary artery abnormalities (e.g., by echocardiogram and, if performed for clinical indications, angiogram, as examples).
- Pulmonary Hypertension [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Prevalence of pulmonary hypertension by echocardiogram and standard of care assessments.
- Cardiovascular System Dysregulation by B-type natriuretic peptide (BNP) Biomarker [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Characterization of cardiovascular system dysregulation by BNP laboratory test.
- Cardiovascular System Dysregulation by Troponin I Biomarker [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Characterization of cardiovascular system dysregulation by Troponin I laboratory test.
- Cardiovascular System Dysregulation by Echocardiogram [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]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.
- Cardiovascular System Dysregulation by Electrocardiogram (ECG) [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]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.
- Pulmonary Abnormalities [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Pulmonary fibrosis (i.e., scarring) or other abnormalities detected by computerized tomography (CT) imaging.
- Pulmonary Function Characteristics [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Characterization by pulmonary function tests (spirometry without bronchodilators).
- Renal/Metabolic Biomarkers: Serum Creatinine and Blood Urea Nitrogen (BUN) [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Characterization of kidney/metabolic function by serum creatinine and blood urea nitrogen (BUN) laboratory tests
- Renal/Metabolic Biomarker: Estimated glomerular filtration rate (eGFR) [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Characterization of kidney/metabolic function by the estimated glomerular filtration rate (eGFR) calculated value, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- Hepatic/Metabolic Biomarkers: Serum Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase ( ALT/SGPT)and Aspartate Aminotransferase (AST/SGOT) [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]
Characterization of liver/metabolic function by the following laboratory tests:
- alkaline phosphatase
- alanine aminotransferase (ALT/SGPT) and
- aspartate aminotransferase (AST/SGOT).
- Hepatic/Metabolic Biomarker: Total Bilirubin [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Characterization of liver/metabolic function by serum total bilirubin laboratory test.
- Neurologic Abnormalities [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Characterization of neurologic sequelae of infection/disease.
- 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) [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]Identified by and characterized during standard of care assessments.
- Health Related Quality of Life [ Time Frame: Up to 1 Year Post Illness Presentation (Enrollment) ]
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).
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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:
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588363
Show 20 study locations
| Study Chair: | Steven A. Webber, MBChB, MRCP | Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt | |
| Principal Investigator: | 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 |
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT04588363 |
| Other Study ID Numbers: |
DAIT PRISM-01 NIAID CRMS ID#: 38772 ( Other Identifier: DAIT NIAID ) |
| First Posted: | October 19, 2020 Key Record Dates |
| Last Update Posted: | September 23, 2022 |
| Last Verified: | September 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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participants <21 years of age observational cohort study immunological responses post infection |
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COVID-19 Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome Disease Pathologic Processes Respiratory Tract Infections Infections |
Pneumonia, Viral Pneumonia Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |