Genomics, Environmental Factors and Social Determinants of Cardiovascular Disease in African-Americans Study (GENE-FORECAST): Prospective COVID-19 Natural History Study

STUDY DESCRIPTION

The objective is to conduct a prospective natural history study of Coronavirus disease 2019 (COVID-19) among a community-based cohort of African Americans enrolled in GENE-FORECAST for whom we have comprehensive psychosocial, clinical, and genetic data collected at baseline. Participants will be invited to take part in a 20-minute computer-assisted telephone interview (CATI) on exposures, attitudes and circumstances during the COVID-19 pandemic and to undergo a clinic visit for a physical exam, vascular function tests and biospecimen collection. We will identify social, clinical and genetic risk factors for COVID-19 and examine the interplay between social determinants of health and personal risk profiles to better understand the disparate burden of COVID-19 in the African American community. It is hypothesized that exposure to the SARS-CoV-2 virus and the development of COVID-19 will be associated with social and neighborhood factors, and that SARS-CoV-2 infection will adversely affect vascular function.

OBJECTIVES

Primary Objectives:

• Define the effect of social factors (e.g., socio-economic status; neighborhood characteristics) on exposure to SARS-CoV-2 and the development of COVID-19.
• Define the effect of SARS-CoV-2 infection and the development of COVID-19 on vascular function (e.g., pulse wave velocity).
• Examine how social factors influence the effect of SARS-CoV-2 and COVID-19 on vascular function.

Secondary Objectives:

• Examine the effects of SARS-CoV-2 infection and COVID-19 on epigenome (whole-blood), transcriptome, (whole-blood, plasma

microvesicles, urine), peripheral blood mononuclear cell (PBMC) single-cell RNA-seq, biomarker profile (e.g., CRP; d-dimer), cardiac function (EKG) and leukocyte telomere length.

• Examine how social factors influence the effect of SARS-CoV-2 infection and COVID-19 on transcriptome and epigenome.

ENDPOINTS

Primary Endpoints:

SARS-CoV-2 infection

Vascular function (e.g., pulse wave velocity; vascular stiffness indices; reactive hyperemia)

Secondary Endpoints:

Transcriptome (whole-blood, plasma microvesicles, urine)

Epigenome (whole-blood)

PBMC single-cell RNA-seq

Leukocyte telomere length

Electrocardiogram (EKG)

Biomarker profile (CRP, D-Dimer, ACE-2, HS-Troponin)

• INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Self-identified African American men and women who previously enrolled in GENE-FORECAST, completed baseline activities and gave permission for recontact through the GENE-FORECAST protocol.
• Stated willingness to participate in study procedures.
• Ability of subject to understand and the willingness to give verbal informed consent for the CATI and the ability to understand and the willingness to sign a written informed consent document for the clinic visit.

Individuals eligible for this protocol are previous GENE-FORECAST participants, all of whom are English speakers. Therefore, by default, this study includes only English speakers.

Exclusion criteria

Only individuals who completed the baseline protocol of GENE-FORECAST and gave permission for recontact through the GENE-FORECAST protocol will be invited to participate. Among this group, there are no exclusions for this study except those who are pregnant.