A Study to Establish An Integrated Biomarker Panel for COVID-19 Infection Risk and Severity Prediction

Overview

About this study

Aim 1: Determine the basal profile of non-genomic factors in patients at the time of exposure to SARS-CoV-2 and correlate with the three clinical patient outcome categories (A, B, C) as observed through their clinical course. 

Hypothesis: Baseline cytokine (IL-1β, IL-6, IL-4, IL-10, IFN-g and TNF-a) and the immune cellular repertoire (helper/CD4+, cytotoxic/CD8+, T-regulatory cells, natural killer cells) constitute the inherent biologic immunity of an individual and underpins their vulnerability to SARS-CoV-2 infectivity and/or its subsequent sequalae. 

Aim 2: Investigate if mutations or polymorphisms in genes (CXCR6, ACE2 and SLC6A20) linked to SARS-CoV-2 correlates with the three clinical patient outcome categories (A, B, C) as observed through their clinical course.

Hypothesis: ACE2 is a cellular receptor for SARS-CoV-2. The high binding affinity of ACE2 to SARS-CoV-2 is determined by its gene sequence and polymorphisms in the ACE2 gene itself or those that regulate ACE2 function (i.e. SLC6A20) can alter this binding potential and thus the clinical impact of the virus. 

Aim 3:  Develop an integrated model of non-genomic (Aim 1) and genomic (Aim 2) factors for prediction of the three potential clinical courses of an individual upon exposure to SARS-CoV-2.  

Hypothesis:  An integrated model incorporating quantitative analysis of cytokines/immune cells (Aim 1) and gene sequence analysis (Aim 2) will allow a more robust and accurate prediction for one of the three potential clinical courses (A, B, C) after SARS-CoV-2 exposure.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years.
  • Mayo Clinic patients that have had exposure to SARS-CoV2 virus and/or symptoms related to COVID-19 infection and present to Mayo Clinic for testing.
  • Patients that are willing to consent for a blood draw and provide a blood sample.

Exclusion Criteria: 

  • Individuals < 18 years  of age.
  • Patients on active treatment for cancer and/or those on immunosuppressants.
  • Pregnant and breast-feeding women.
  • Patients who have had COVID-19 in the past, confirmed in the medical record.
  • Patients who are unable to give written/verbal consent or are unwilling to participate.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Alicia Algeciras-Schimnich, Ph.D.

Closed for enrollment

Contact information:

Rochelle Fabian M.A.

(507) 538-3259

Fabian.Rochelle@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Pooja Advani, M.B.B.S., M.D.

Closed for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available