NCT04939155

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

June 14, 2021

Last Update Submit

June 24, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Overall state of health

    Change from baseline after COVID-19 infection

  • Overall state of health

    Change from baseline after COVID-19 mRNA vaccination

Study Arms (2)

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

Interventions

SARS-CoV-2 mRNA vaccineBIOLOGICAL

mRNA vaccine for COVID

Patients who have received an mRNA vaccination

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TruDiagnostic

Lexington, Kentucky, 40503, United States

Location

Related 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):323. doi: 10.3390/cells10020323.

    PMID: 33557301BACKGROUND

  • 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.

    PMID: 32273594BACKGROUND

  • 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.

    PMID: 32393526BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

CVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 25, 2021

Study Start

March 10, 2021

Primary Completion

October 1, 2021

Study Completion

March 10, 2022

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)