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Trial registered on ANZCTR


Registration number
ACTRN12622000506796
Ethics application status
Approved
Date submitted
17/03/2022
Date registered
30/03/2022
Date last updated
31/10/2022
Date data sharing statement initially provided
30/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Long-term outcomes of myocarditis and pericarditis after Pfizer COVID-19 vaccination
Scientific title
Long-term outcomes of myocarditis and pericarditis after Pfizer-BioNTech (Comirnaty) COVID-19 vaccination in children and adults
Secondary ID [1] 306712 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocarditis 325683 0
Pericarditis 325684 0
COVID-19 vaccine 325685 0
Condition category
Condition code
Cardiovascular 323034 323034 0 0
Other cardiovascular diseases
Public Health 323130 323130 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Myocarditis and pericarditis have been recognised by Medsafe and international regulators as a rare side effect of vaccination with mRNA COVID-19 vaccines, such as the Pfizer vaccine (Comirnaty). More information is needed to understand the long-term outcomes (>3 months) in people who experience myocarditis and/or pericarditis following vaccination with the Pfizer vaccine.

The study will be delivered as a survey to consumers and their healthcare provider.
1) The consumer survey will collect data on participant demographics, diagnosis, health and functional status, medicines, and medical history.
2) The healthcare provider survey will include questions on diagnosis and aetiology, tests and investigations, clinical management, and medical history.
The consumer survey will be a one-off survey of approximately 30 minutes, these will be delivered primarily through phone interviews conducted by experienced nurse interviewers through a health survey company. The option of face to face interviews will also be available (COVID-19 restrictions permitting) if the participant prefers. Participants will be given the opportunity to provide the name and contact details for their healthcare provider (General Practitioner/Nurse Practitioner or Practice Nurse and/or specialist) and to consent for us to contact them for the purposes of a survey. The healthcare provider survey will be predominantly online, however the option for this to be done by other mechanism will also be available.
Participants should have received a diagnosis of myocarditis and/or pericarditis any dose of their Pfizer COVID-19 vaccine between 20 February 2021 and 28 February 2022. People will be contacted to participate between March 2022 and July 2022.
Updated from
Myocarditis and pericarditis have been recognised by Medsafe and international regulators as a rare side effect of vaccination with mRNA COVID-19 vaccines, such as the Pfizer vaccine (Comirnaty). More information is needed to understand the long-term outcomes (>3 months) in people who experience myocarditis and/or pericarditis following vaccination with the Pfizer vaccine.

The study will be delivered as a survey to consumers and their healthcare provider.
1) The consumer survey will collect data on participant demographics, diagnosis, health and functional status, medicines, and medical history.
2) The healthcare provider survey will include questions on diagnosis and aetiology, tests and investigations, clinical management, and medical history.
The consumer survey will be a one-off survey of approximately 30 minutes, these will be delivered primarily through phone interviews conducted by experienced nurse interviewers through a health survey company. The option of face to face interviews will also be available (COVID-19 restrictions permitting) if the participant prefers. Participants will be given the opportunity to provide the name and contact details for their healthcare provider (General Practitioner/Nurse Practitioner or Practice Nurse and/or specialist) and to consent for us to contact them for the purposes of a survey. The healthcare provider survey will be predominantly online, however the option for this to be done over the phone with an interviewer will also be available.
Participants should have received a diagnosis of myocarditis and/or pericarditis after dose one or two of their Pfizer COVID-19 vaccine between 20 February 2021 and 31 December. 2021. People will be contacted to participate between March 2022 and June 2022.  
Reason: Study population extended to include booster doses and time for data collection extended accordingly. At the time of the change 173 participants have been recruited. The recruited participants are not impacted by the change.
Updated on 9/06/2022 9:54:49 AM
Intervention code [1] 323157 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330794 0
Current health – symptom type and duration, overall health
We have a questionnaire specific for this study which has been based on survey questions being used by the CDC in a similar study.
Questions on general health and mental health from a recent New Zealand Health Survey and COVID-19 Health and Wellbeing Survey may also be included to allow for comparison with the general population of New Zealand.
Timepoint [1] 330794 0
Once at a minimum of 3 months after clinical diagnosis
Primary outcome [2] 330795 0
Physical functioning – current level of physical activity
We have a questionnaire specific for this study which has been based on survey questions being used by the CDC in a similar study.
Questions on general health and mental health from a recent New Zealand Health Survey and COVID-19 Health and Wellbeing Survey may also be included to allow for comparison with the general population of New Zealand.
Timepoint [2] 330795 0
Once at a minimum of 3 months after clinical diagnosis
Primary outcome [3] 330796 0
Mental health
We have a questionnaire specific for this study which has been based on survey questions being used by the CDC in a similar study.
Questions on general health and mental health from a recent New Zealand Health Survey and COVID-19 Health and Wellbeing Survey may also be included to allow for comparison with the general population of New Zealand.
Timepoint [3] 330796 0
Once at a minimum of 3 months after clinical diagnosis
Secondary outcome [1] 407596 0
Hospitalisations – number of hospital admissions, length of stay, level of care required.
This data will be collected using a questionnaire specific for this study which has been based on survey questions being used by the CDC in a similar study.
In addition where consent from the participant is provided, we will access the primary healthcare record (where available) and also linkage to the National Minimum Dataset (hospitalisations).
Timepoint [1] 407596 0
Once at a minimum of 3 months after clinical diagnosis
Secondary outcome [2] 407597 0
Cardiac health – overall recovery, exercise restrictions, medications, cardiac test results (troponin, ECG, echocardiogram, cardiac MRI, other).
This data will be collected using a questionnaire specific for this study which has been based on survey questions being used by the CDC in a similar study.
In addition where consent from the participant is provided, we will access the primary healthcare record (where available).
Timepoint [2] 407597 0
Once at a minimum of 3 months after clinical diagnosis
Secondary outcome [3] 407598 0
Aetiology – COVID-19 test results, past medical history, suspected cause
This data will be collected using a questionnaire specific for this study which has been based on survey questions being used by the CDC in a similar study.
In addition where consent from the participant is provided, we will access the primary healthcare record (where available) and also linkage to COVID-19 testing history.
Timepoint [3] 407598 0
Once at a minimum of 3 months after clinical diagnosis

Eligibility
Key inclusion criteria
1) Adults and children 12 years of age or older with a clinical diagnosis of myocarditis and/or pericarditis (includes myopericarditis), after any dose of the Pfizer vaccine, and their healthcare providers.
2) A report of myocarditis and/or pericarditis has been submitted to the Centre for Adverse Reactions Monitoring (CARM) by the person themselves, or by someone on their behalf (such as a healthcare professional or family member).
3) Participants will not be required to meet specific diagnostic criteria, such as the CDC criteria, to be eligible.
4) Myocarditis and/or pericarditis diagnosed up to and including 28 February 2022, and at least 3 months prior to the survey (minimum of 3 months post-diagnosis).
Updated from
1) Adults and children 12 years of age or older with a clinical diagnosis of myocarditis and/or pericarditis (includes myopericarditis), after dose 1 or 2 of the Pfizer vaccine, and their healthcare providers.
2) A report of myocarditis and/or pericarditis has been submitted to the Centre for Adverse Reactions Monitoring (CARM) by the person themselves, or by someone on their behalf (such as a healthcare professional or family member).
3) Participants will not be required to meet specific diagnostic criteria, such as the CDC criteria, to be eligible.
4) Myocarditis and/or pericarditis diagnosed up to and including 31 December 2021, and at least 3 months prior to the survey (minimum of 3 months post-diagnosis).
  
Reason: Study population extended to include boosters. At the time of the change 173 participants have been recruited. The recruited participants are not impacted by the change.
Updated on 9/06/2022 9:54:49 AM
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Children <12 years of age.
2) People who have not received a clinical diagnosis of myocarditis and/or pericarditis. This includes self-diagnosis, or where a diagnosis of myocarditis or pericarditis was considered as part of the differential diagnosis but was not given as a final diagnosis.
3) Myocarditis and/or pericarditis diagnosed after 28 February 2022, and/or less than 3 months ago by the end of the specified recruitment period.
4) People who experienced myocarditis and/or pericarditis after a third or subsequent dose of the Pfizer vaccine.
5) People who did not receive the Pfizer vaccine prior to being diagnosed with myocarditis or pericarditis.
6) People who experienced myocarditis and/or pericarditis after vaccination with another COVID-19 vaccine (for example, the AstraZeneca vaccine).
7) People who have not provided sufficient contact information in CARM report to be able to make initial contact.
8) Circumstances that interfere with the participant’s ability to give informed consent (including a diminished understanding or comprehension of English and an interpreter unavailable).
Updated from
1) Children <12 years of age.
2) People who have not received a clinical diagnosis of myocarditis and/or pericarditis. This includes self-diagnosis, or where a diagnosis of myocarditis or pericarditis was considered as part of the differential diagnosis but was not given as a final diagnosis.
3) Myocarditis and/or pericarditis diagnosed after 31 December 2021, and/or less than 3 months ago by the end of the specified recruitment period.
4) People who experienced myocarditis and/or pericarditis after a third or subsequent dose of the Pfizer vaccine.
5) People who did not receive the Pfizer vaccine prior to being diagnosed with myocarditis or pericarditis.
6) People who experienced myocarditis and/or pericarditis after vaccination with another COVID-19 vaccine (for example, the AstraZeneca vaccine).
7) People who have not provided sufficient contact information in CARM report to be able to make initial contact.
8) Circumstances that interfere with the participant’s ability to give informed consent (including a diminished understanding or comprehension of English and an interpreter unavailable).
  
Reason: Study population extended to include boosters. At the time of the change 173 participants have been recruited. The recruited participants are not impacted by the change.
Updated on 9/06/2022 9:54:49 AM

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
A descriptive analysis of quantitative survey data will be performed. A narrative summary of any additional information collected during the survey may be conducted. Data linkage will be performed with other relevant health data and data collected from surveys.

Outcomes will be analysed separately based on diagnosis (myocarditis and/or pericarditis). Subgrouping may also be performed based on the CDC criteria (met/not met) and/or Brighton Criteria (level 1-3/level 4-5), age, and gender, if sufficient information is collected. Sensitivity analysis may be conducted based on time to onset of symptoms/diagnosis (< or > 30 days). Most cases of myocarditis and/or pericarditis after vaccination occur within the first 7 days.

Cases where an alternative aetiology (other than the COVID-19 vaccine) was confirmed or highly suspected will be excluded from the analysis.

Recruitment
Recruitment status
Completed
Updated from
Recruiting  
Reason: recruitment complete, data analysis underway
Updated on 31/10/2022 1:56:02 PM
Updated from
Not yet recruiting  
Reason: Study has not started recruiting participants
Updated on 13/04/2022 4:16:46 PM
Date of first participant enrolment
Anticipated
31/03/2022
Actual
30/03/2022
Updated from
 
Reason: Some participants were contacted and interviewed on 30/03
Updated on 13/04/2022 4:16:46 PM
Date of last participant enrolment
Anticipated
14/07/2022
Actual
31/08/2022
Updated from
31/05/2022 
Reason: Study population extended to include booster doses.
Updated on 9/06/2022 9:54:49 AM
Updated from
 
Reason: enrolment complete
Updated on 31/10/2022 1:56:02 PM
Date of last data collection
Anticipated
29/07/2022
Actual
10/10/2022
Updated from
30/06/2022 
Reason: Study population extended to include booster doses.
Updated on 9/06/2022 9:54:49 AM
Updated from
 
Reason: data collection complete
Updated on 31/10/2022 1:56:02 PM
Sample size
Target
400
Accrual to date
Final
323
Updated from
300 
Reason: Study population extended to include booster doses.
Updated on 9/06/2022 9:54:49 AM
Updated from
173 
Reason: Recruitment complete
Updated on 31/10/2022 1:56:02 PM
Updated from
65 
Reason: Initial cohort (dose one and two) contacted
Updated on 9/06/2022 9:54:49 AM
Updated from
 
Reason: Number of participants contacted and interviewed
Updated on 13/04/2022 4:16:46 PM
Updated from
 
Reason: recruitment complete
Updated on 31/10/2022 1:56:02 PM
Recruitment outside Australia
Country [1] 24671 0
New Zealand
State/province [1] 24671 0

Funding & Sponsors
Funding source category [1] 311039 0
Government body
Name [1] 311039 0
Ministry of Health
Country [1] 311039 0
New Zealand
Updated from
Australia  
Reason: Incorrect previously
Updated on 9/06/2022 9:54:49 AM
Primary sponsor type
Government body
Name
Medsafe
Address
133 Molesworth Street
Thorndon
Wellington
6011
Country
New Zealand
Secondary sponsor category [1] 312368 0
None
Name [1] 312368 0
Address [1] 312368 0
Country [1] 312368 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310587 0
Covid-19 ESOP Health and Disability Ethics Committee
Ethics committee address [1] 310587 0
Ethics committee country [1] 310587 0
New Zealand
Date submitted for ethics approval [1] 310587 0
11/02/2022
Approval date [1] 310587 0
18/02/2022
Ethics approval number [1] 310587 0
2022 FULL 11589
Ethics committee name [2] 310588 0
Northern B Health and Disability Ethics Committee
Ethics committee address [2] 310588 0
Ethics committee country [2] 310588 0
New Zealand
Date submitted for ethics approval [2] 310588 0
24/02/2022
Approval date [2] 310588 0
04/03/2022
Ethics approval number [2] 310588 0
2022 AM 11589

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118178 0
Dr Tim Hanlon
Address 118178 0
Ministry of Health
133 Molesworth Street
Thorndon
Wellington
6011
Country 118178 0
New Zealand
Phone 118178 0
+64 04 819 6800
Fax 118178 0
Email 118178 0
C19myostudy@health.govt.nz
Contact person for public queries
Name 118179 0
Tim Hanlon
Address 118179 0
Ministry of Health
133 Molesworth Street
Thorndon
Wellington
6011
Country 118179 0
New Zealand
Phone 118179 0
+64 04 819 6800
Fax 118179 0
Email 118179 0
C19myostudy@health.govt.nz
Contact person for scientific queries
Name 118180 0
Tim Hanlon
Address 118180 0
Ministry of Health
133 Molesworth Street
Thorndon
Wellington
6011
Country 118180 0
New Zealand
Phone 118180 0
+64 04 819 6800
Fax 118180 0
Email 118180 0
C19myostudy@health.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data available in the public domain will be anonymized and grouped.


What supporting documents are/will be available?

Supporting Document [1] (Reference No. 15454)
Show/Hide History
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Informed consent form  C19myostudy@health.govt.nz  


Results publications and other study-related documents

No Study Results Provided