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COMIRNATY Vaccine Long-Term Effects for Myocarditis
Study Summary
This trial will compare long-term effects of myocarditis/pericarditis following vaccination with COMIRNATY to those following infection with COVID-19 in people under 21, with follow-up for up to 5 years.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I likely have or am confirmed to have heart inflammation.I have COVID-19 or MIS-C with heart inflammation not caused by the COMINARTY vaccine.I was evaluated in the ER or hospitalized at a participating medical center.I can sign the consent form myself or my guardian can, and I agree to follow the study rules.I received a COMIRNATY vaccine dose within 28 days before my symptoms started.I am younger than 21 years old.I do not have serious heart conditions that could affect the study.I am younger than 21 years old.The site will check if there could be another reason for heart inflammation based on their usual way of looking for causes of heart inflammation.You have been diagnosed with myocarditis or pericarditis according to the Centers for Disease Control and Prevention guidelines.
- Group 1: myocarditis/pericarditis following COVID-19 or MIS-C
- Group 2: myocarditis/pericarditis following COMIRNATY
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How would you appraise the risk of this intervention to participants?
"The safety of this medication has been confirmed by prior clinical data, thus receiving a score of 3. This is indicative of the treatment having achieved Phase 4 status and official approval."
Does the trial accept participants under the age of 25?
"This medical trial is intended for patients between the ages of 0 and 20. There are 3 separate studies available to those under 18, while individuals over 65 may join 23 other clinical trials."
Are there any available slots open for participants in this clinical trial?
"According to the information on clinicaltrials.gov, this particular medical experiment is not looking for participants at present. After being first published on October 1st 2022 and edited most recently in mid-October of that same year, recruiting has concluded. Nevertheless, 24 other trials are still actively seeking patients as we speak."
For whom is this clinical experiment accepting participants?
"This clinical trial is accepting 300 participants aged 0 to 20 with carditis. The requirements are as follows: Age must be below 21, a COMIRNATY vaccine dose should have been received within 28 days of the onset of symptoms, meeting Centers for Disease Control and Prevention case definition criteria; granting consent (or waiver in some cases); COVID-19 diagnosis or MIS-C; elevated troponin levels above normal range; abnormal ECG/rhythm monitoring tests consistent with myocarditis."
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