Methylation Effects of COV-19 Infection and Vaccinations

Measuring the DNA Methylation Effects From COVID-19 Infection and COVID-vaccinations

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19
• Intervention / Treatment: Biological: SARS-CoV-2 mRNA vaccine

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • TruDiagnostic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients infected with SARS-CoV-2; 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; 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.	Biological: SARS-CoV-2 mRNA vaccine; mRNA vaccine for COVID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Methylation age clock testing	The DNA clocks that will be used to precisely measure aging is TruAge Biological Age test, which estimates biological age vs. chronological age	Change from baseline after COVID-19 infection
Methylation age clock testing	The DNA clocks that will be used to precisely measure aging is TruAge Biological Age test, which estimates biological age vs. chronological age	Change from baseline after COVID-19 mRNA vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall state of health	Questionnaire assessing overall health	Change from baseline after COVID-19 infection
Overall state of health	Questionnaire assessing overall health	Change from baseline after COVID-19 mRNA vaccination

Collaborators and Investigators

• Sponsor: TruDiagnostic
• Collaborators: Cornell University

Publications and helpful links

General Publications

• Bonek K, Roszkowski L, Massalska M, Maslinski W, Ciechomska M. Biologic Drugs for Rheumatoid Arthritis in the Context of Biosimilars, Genetics, Epigenetics and COVID-19 Treatment. Cells. 2021 Feb 4;10(2):323. doi: 10.3390/cells10020323.
• Cao X. COVID-19: immunopathology and its implications for therapy. Nat Rev Immunol. 2020 May;20(5):269-270. doi: 10.1038/s41577-020-0308-3.
• Corey L, Mascola JR, Fauci AS, Collins FS. A strategic approach to COVID-19 vaccine R&D. Science. 2020 May 29;368(6494):948-950. doi: 10.1126/science.abc5312. Epub 2020 May 11. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): March 10, 2022

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: TD-ME-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No