Human genetics of myocarditis: overall, after mRNA COVID-19 vaccination, and after SARS-CoV-2 infection

Study identification

• EU PAS number:
  EUPAS1000000728
• Study ID:
  1000000728
• Official title and acronym:
  Human genetics of myocarditis: overall, after mRNA COVID-19 vaccination, and after SARS-CoV-2 infection
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a non-interventional, retrospective case-control genetic association study using secondary data from the US-based Helix Research Network (HRN) Myocarditis Registry, where patients with myocarditis (cases) and patients without myocarditis (controls) will be identified. Cases and controls will be individuals who previously consented to participate in genetic research studies and for whom clinical information is available. ; The study will include the below three cohorts of cases. ; • Cohort A – post-mRNA COVID-19 vaccination myocarditis cases: myocarditis within 14 days of mRNA vaccination ; • Cohort B – post-SARS-CoV-2 infection myocarditis cases: myocarditis within 8 weeks of SARS-CoV-2 infection; • Cohort C – acute/viral myocarditis cases: myocarditis unrelated to COVID-19 vaccination or SARS-CoV-2 infection; Controls will be individuals without myocarditis who previously consented to participate in the HRN. ;
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Helix, Inc.

Study timelines

Date when funding contract was signed

Planned:06/06/2023

Actual:06/06/2023

Study start date

Planned:09/01/2026

Date of final study report

Planned:28/08/2026

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

C4591078