Methylation Effects of COV-19 Infection and Vaccinations

NCT ID: NCT04939155

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-10

Study Completion Date

2022-03-10

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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.

SARS-CoV-2 mRNA vaccine

Intervention Type BIOLOGICAL

mRNA vaccine for COVID

Interventions

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SARS-CoV-2 mRNA vaccine

mRNA vaccine for COVID

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cornell University

OTHER

Sponsor Role collaborator

TruDiagnostic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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TruDiagnostic

Lexington, Kentucky, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 33557301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32273594 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32393526 (View on PubMed)

Other Identifiers

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TD-ME-001

Identifier Type: -

Identifier Source: org_study_id