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NCT04939155 Clinical Trial

Methylation Effects of COV-19 Infection and Vaccinations

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04939155
Other study ID # TD-ME-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 10, 2021
Est. completion date March 10, 2022

Study information
Verified date June 2021
Source TruDiagnostic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date March 10, 2022
Est. primary completion date October 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subjects that are healthy individuals and of any sex, ethnicity, and anyone above the age of 18 years old.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• SARS-CoV-2 mRNA vaccine
mRNA vaccine for COVID

Locations
Country Name City State
United States TruDiagnostic Lexington Kentucky

Sponsors (2)
Lead Sponsor Collaborator
TruDiagnostic Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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). pii: 323. doi: 10.3390/cells10020323. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Overall state of health Questionnaire assessing overall health Change from baseline after COVID-19 infection
Secondary Overall state of health Questionnaire assessing overall health Change from baseline after COVID-19 mRNA vaccination
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