Overview
Tab Title Description
Tipo de estudio
ObservationalDescribe la naturaleza de un estudio clínico. Los tipos incluyen los siguientes:
- Estudio observacional, en el que se observan personas y se miden los resultados sin afectarlos.
- Estudio intervencionista (ensayo clínico), en el que se estudian nuevos exámenes, tratamientos, medicamentos, procedimientos quirúrgicos o dispositivos.
- Las investigaciones basadas en expedientes médicos utilizan la información histórica recopilada a partir de los registros médicos de grandes grupos de personas para estudiar cómo evolucionan las enfermedades y qué tratamientos y cirugías son más eficaces.
Identificaciones del estudio
Comité de revisión institucional de la sede
- Rochester, Minnesota: 21-001923
- Jacksonville, Florida: 21-001923
Información sobre este estudio
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.