Methylation Effects of COV-19 Infection and Vaccinations

Sponsor
TruDiagnostic (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04939155
Collaborator
Cornell University (Other)
60
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12
5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: SARS-CoV-2 mRNA vaccine

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Measuring the DNA Methylation Effects From COVID-19 Infection and COVID-vaccinations
Actual Study Start Date :
Mar 10, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Mar 10, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Methylation age clock testing [Change from baseline after COVID-19 infection]

    The DNA clocks that will be used to precisely measure aging is TruAge Biological Age test, which estimates biological age vs. chronological age

  2. Methylation age clock testing [Change from baseline after COVID-19 mRNA vaccination]

    The DNA clocks that will be used to precisely measure aging is TruAge Biological Age test, which estimates biological age vs. chronological age

Secondary Outcome Measures

  1. Overall state of health [Change from baseline after COVID-19 infection]

    Questionnaire assessing overall health

  2. Overall state of health [Change from baseline after COVID-19 mRNA vaccination]

    Questionnaire assessing overall health

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Subjects that are healthy individuals and of any sex, ethnicity, and anyone above the age of 18 years old.

Contacts and Locations

Locations

Site City State Country Postal Code
1 TruDiagnostic Lexington Kentucky United States 40503

Sponsors and Collaborators

  • TruDiagnostic
  • Cornell University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
TruDiagnostic
ClinicalTrials.gov Identifier:
NCT04939155
Other Study ID Numbers:
  • TD-ME-001
First Posted:
Jun 25, 2021
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2021