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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05295290
Other study ID # C4591036
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 21, 2022
Est. completion date November 21, 2030

Study information

Verified date June 2024
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this clinical trial is to learn about the safety and effects of the study vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who: 1. Are age <21 years. 2. Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. 3. Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 7 days of symptom onset. 4. Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis 5. Are capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent. This study will examine the potential long-term effects associated with myocarditis/pericarditis following vaccination with COMIRNATY. The association of myocarditis/pericarditis in participants who received the study vaccine (COMIRNATY) compared with those associated with COVID-19 will also be examined. This will help us determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted. Participants will take part in this study for up to 5 years. During this time, they will receive complete cardiac imaging tests, and have follow up visits per guidance stated in the study protocol.


Description:

This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons <21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C. To be classified as having COMIRNATY-associated myocarditis/pericarditis, a person must 1) meet the CDC case definition for probable or confirmed myocarditis/pericarditis, 2) have received any dose of COMIRNATY ≤ 7 days of symptom onset, and 3) have no other plausible alternative etiology at the time of enrollment. To be classified as having myocarditis/pericarditis associated with COVID-19, a person must have 1) either acute severe COVID-19 infection or MIS-C, as defined by the CDC, 2) findings of probable or confirmed myocarditis in the CDC definition, 3) no other plausible alternative etiology. A description of the three cohorts is as follows: Cohort 1: Prospectively ascertained cases of probable or confirmed myocarditis/pericarditis associated with COMIRNATY , i.e., participants enrolled under protocol during hospitalization or 2 weeks after hospital discharge. Participants can be retrospectively ascertained and enrolled at any time from their COMIRNATY-associated myocarditis/pericarditis. Cohort 3: Comparator cohort of COVID-19- related myocarditis/pericarditis , including MIS-C, both retrospectively and prospectively ascertained, and enrolled at any time from their COVID-19 or MIS-C associated myocarditis/pericarditis diagnosis. Participants in all cohorts will be those who present to participating medical centers for care. This study is a collaboration between the National Heart, Lung, and Blood Institute (NHLBI)'s Pediatric Heart Network (PHN) and Pfizer. Enrollment will include approximately 300 prospectively and retrospectively ascertained cases of children, adolescents, and young adults <21 years of age who receive care for myocarditis/pericarditis associated with COMIRNATY (Cohort 1 and 2); and approximately 100 persons <21 years of age with COVID -19-associated myocarditis/pericarditis, including MIS-C (Cohort 3).


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date November 21, 2030
Est. primary completion date November 21, 2030
Accepts healthy volunteers No
Gender All
Age group 0 Years to 20 Years
Eligibility Inclusion Criteria: - Cohort 1/2: 1. Age <21 years. 2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. 3. Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 28 days of symptom onset. 4. Meets criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis 5. Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent. - Cohort 3: 1. Age <21 years. 2. Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. 3. COVID-19-related disease 1. Acute COVID-19 infection OR 2. Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND 4. Probable or confirmed myocarditis/pericarditis* not temporally related to vaccination with COMINARTY 1. Probable myocarditis/pericarditis as defined by = 1 new finding of: - Elevated troponin above upper limit of normal - Abnormal ECG or rhythm monitoring finding consistent with myocarditis - Abnormal cardiac function or wall motion abnormalities on echocardiogram - cMRI findings consistent with myocarditis OR 2. Confirmed myocarditis/pericarditis as defined by: - Histopathologic confirmation of myocarditis OR - Elevated troponin above upper limit of normal AND cMRI findings consistent with myocarditis 5. Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent. Exclusion Criteria: 1. A plausible alternative etiology for myocarditis/pericarditis, as determined by the site based upon their routine clinical practice for evaluation of potential causes for myocarditis/pericarditis. 2. Pre-existing cardiac conditions that could impact the primary endpoint, including but not limited to, documented history of left ventricular dysfunction (e.g., cardiomyopathy or myocardial infarction), pacemaker, or congenital heart disease, with the exceptions of: 1. Bicommissural aortic valve with < trivial stenosis and/or insufficiency 2. Mitral valve prolapse with < trivial insufficiency 3. Hemodynamically insignificant atrial septal or ventricular septal defects. 3. Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement).

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Cardiac Imaging
ECG, echocardiogram, ambulatory monitor, exercise stress test

Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario
United States University of Michigan Hospital-Mott Children's Hospital Ann Arbor Michigan
United States Children's Healthcare of Atlanta - Egleston Atlanta Georgia
United States Childrens Hospital of Colorado Aurora Colorado
United States Children's of Alabama Birmingham Alabama
United States Boston Children's Hospital Boston Massachusetts
United States Medical University of South Carolina (Musc) - Children's Hospital Charleston South Carolina
United States Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital Charleston South Carolina
United States Lurie Children's Hospital Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Children's Hospital of Michigan Detroit Michigan
United States Duke University Hospital Durham North Carolina
United States Duke University Hospital Durham North Carolina
United States Connecticut Children's Medical Center Hartford Connecticut
United States Baylor College Of Medicine (Bcm) - Texas Children's Hospital (Tch) Houston Texas
United States Texas Children's Hospital Houston Texas
United States Texas Children's Hospital Houston Texas
United States Indiana University Indianapolis Indiana
United States Indiana University School of Medicine Indianapolis Indiana
United States Childrens Mercy Kansas City Kansas City Missouri
United States Childrens Hospital Los Angeles Los Angeles California
United States Valley Children's Hospital Madera California
United States Northwell Health-Cohen Children's Medical Center New Hyde Park New York
United States Children's Hospital New Orleans Louisiana
United States Columbia University Medical Center New York New York
United States Lucile Packard Children's Hospital Stanford Palo Alto California
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Phoenix Children's Hospital Phoenix Arizona
United States UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
United States Washington University School of Medicine Saint Louis Missouri
United States Primary Children's Salt Lake City Utah
United States Primary Children's Hospital Salt Lake City Utah
United States Seattle Children's Hospital Seattle Washington
United States Seattle Children's Hospital & Research Institute Seattle Washington
United States Childrens National Hospital Washington District of Columbia
United States Nemours Children's Hospital, Delaware Wilmington Delaware

Sponsors (3)

Lead Sponsor Collaborator
Pfizer Carelon Research, National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite findings of myocarditis This is a single composite primary outcome measure. This primary composite study endpoint is defined as the presence of 1 or more of the following 6 months after illness onset: left ventricular dysfunction (LVEF < 55% by echocardiogram), findings of myocarditis by original or revised Lake Louise criteria on cardiac MRI, or the presence of high-grade arrhythmia or conduction system disturbance on ECG or ambulatory monitoring. 6 months after illness onset
Primary Left ventricular ejection fraction (LVEF) < 55% by echocardiography Up to 5 years following illness onset.
Primary Myocarditis by original or revised Lake Louise criteria on cMRI Up to 5 years following illness onset.
Primary Arrhythmias on cardiac recording (ECG, ambulatory monitoring) Up to 5 years following illness onset.
Primary Complications, including non-cardiac morbidities by medical history Up to 5 years following illness onset.
Primary Functional Status by Behavior Assessment System for Children, Third Edition BASC-3 or PROMIS Short Forms Behavior Assessment System for Children, Third Edition (BASC-3), <8 yr (T score <30->70 with higher number meaning lower functioning) or PROMIS Short Forms =8 yr (scores from 3-15 with higher number meaning better functioning) Up to 5 years following illness onset.
Primary The Pediatric Quality of Life Inventory (PEDS QL) The 27 question, age-appropriate and parent-proxy questionnaires, will be used in 2 to <18-year-old participants to assess quality of life. Scores span 0-108 with higher number being better functioning. Up to 5 years following illness onset.
Primary The Quality of Life Scale (QOLS) The QOLS, a 16-item self-report form that assesses overall quality of life on a scale of 16-112 (higher scores indicate better quality of life) will be administered for participants =18 years old. Up to 5 years following illness onset.
Primary Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring) Up to 5 years following illness onset.
Secondary Left ventricular ejection fraction (LVEF) by echocardiogram as a measure of myocardial performance. During the hospitalization or within 2 weeks of hospital discharge, generally obtained less than 3 weeks from presentation.
Secondary Time to recovery of myocardial inflammation and injury by Lake Louise (the original or revised) criteria During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Secondary Arrhythmias on cardiac recording (ECG, ambulatory monitoring) During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Secondary Complications, including non-cardiac morbidities for myocarditis During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Secondary Echocardiographic LVEF Up to 5 years following illness onset.
Secondary Myocardial inflammation scarring (by cMRI) Up to 5 years following illness onset.
Secondary Arrhythmias on cardiac recordings Up to 5 years following illness onset.
Secondary Complications, including non-cardiac morbidities by medical history Up to 5 years following illness onset.
Secondary Lower LVEF by composite results Identification of possible sociodemographic and medical risk factors for greater frequency and severity of acute and longer-term cardiac sequelae in participants, measured by ECG, original or revised Lake Louise criteria on cMRI, and presence of high-grade arrhythmia or conduction system disturbance on ECG or ambulatory monitoring. Up to 5 years following illness onset.
Secondary For patients with isolated pericarditis, to determine time to recovery to normal. Freedom from
symptoms/signs of pericarditis;
typical ECG findings of pericarditis;
>small pericardial effusion;
therapy with anti-inflammatory medications
At each study visit, up to 5 years, until the endpoint event is met
Secondary Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring) During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Secondary Conduction system disturbances on cardiac recordings Up to 5 years following illness onset.
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