Methylation Effects of COV-19 Infection and Vaccinations

TruDiagnostic

Status: Unknown

Conditions: Covid19

Treatments: Biological: SARS-CoV-2 mRNA vaccine

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04939155

TD-ME-001

Details and patient eligibility

About

This is a retrospective non-randomized clinical study of 60 patients total to assess the effects of SARS-CoV-2 infection and the SARS-CoV-2 vaccination. This study will have 2 arms evaluating the epigenomes of patients pre and post-exposure to one of the interventions. The first arm of the study will analyze 40 patients' epigenomes whose DNA methylation was examined pre and post SARS-CoV-2 infection. The second arm of this study is analyzing 20 patients' epigenomes whose DNA methylation was examined pre and post-injection of the SARS-CoV-2 vaccine.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects that are healthy individuals and of any sex, ethnicity, and anyone above the age of 18 years old.

Trial design

60 participants in 2 patient groups

Patients infected with SARS-CoV-2

Description:

The first part of this study looks at the methylation patterns in individuals who have a baseline test taken of their DNA methylation patterns in their epigenome and then a follow-up test after they contracted SARS-CoV-2

Patients who have received an mRNA vaccination

Description:

The second part of the study looks at the methylation patterns in individuals who have a baseline test taken of their DNA methylation patterns in their epigenome and then a follow-up test after SARS CoV-2 mRNA vaccine injection.

Treatment:

Biological: SARS-CoV-2 mRNA vaccine