We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Methylation Effects of COV-19 Infection and Vaccinations
Previous Study | Return to List | Next Study

Methylation Effects of COV-19 Infection and Vaccinations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04939155
Recruitment Status : Active, not recruiting
First Posted : June 25, 2021
Last Update Posted : June 30, 2021
Sponsor:
Collaborator:
Cornell University
Information provided by (Responsible Party):
TruDiagnostic

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Covid19 Biological: SARS-CoV-2 mRNA vaccine

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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 : March 10, 2021
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : March 10, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Methylation age clock testing [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from baseline after COVID-19 infection ]
    Questionnaire assessing overall health

  2. Overall state of health [ Time Frame: Change from baseline after COVID-19 mRNA vaccination ]
    Questionnaire assessing overall health


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

Inclusion Criteria:

  • Subjects that are healthy individuals and of any sex, ethnicity, and anyone above the age of 18 years old.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939155


Locations
Layout table for location information
United States, Kentucky
TruDiagnostic
Lexington, Kentucky, United States, 40503
Sponsors and Collaborators
TruDiagnostic
Cornell University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: TruDiagnostic
ClinicalTrials.gov Identifier: NCT04939155    
Other Study ID Numbers: TD-ME-001
First Posted: June 25, 2021    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Respiratory Tract Infections
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 COVID-19
Pneumonia, Viral
Pneumonia
Virus Diseases
Lung Diseases
Respiratory Tract Diseases