Analysis of the Inflammatory Response and the Development of Humoral and Cellular Immunity in Patients With COVID-19

Study Overview
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Brief Summary
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The SARS-CoV-2 infection in the airway epithelium induces cytopathic effects and the cessation of ciliary movement. Increased cytokines and chemokines have been reported to be associated with the severity of the disease. However, most of the molecular and cellular aspects of the inflammatory response and the processes of development of humoral and cellular immunity in these patients are unknown. The aim of this study is characterizing inflammatory processes, seeking to expand the knowledge of the cellular and molecular pathophysiology of COVID-19 that could help in the decision-making of treating health personnel. Mainly, the study is focused on analyzing the inflammatory response by determining cytokines and chemokines. Also, the viral load of the patients with COVID-19 will be determined and will be correlated with the antibody titers. On the other hand, cells will be immunophenotyped to search the cellular depletion profile. Finally, an epidemiological analysis of the patients will be carried out.

Official Title
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The Analysis of the Inflammatory Response and the Development of Humoral and Cellular Immunity in Patients With Coronavirus Disease 2019 (COVID-19)

Conditions
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SARS-CoV-2

Intervention / Treatment
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* Other: Active COVID-19 disease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 16 years old with positive molecular diagnosis of Covid-19, in the Laboratory of IMSS Exclusion Criteria: Patients with immunosuppressive diseases: HIV +, Hepatitis C virus, primary immunodeficiencies, rheumatoid arthritis, lupus erythematosus and patients under treatment with immunosuppressants

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID Patients<br>Diagnosed patients with COVID-19 by PCR | Other: Active COVID-19 disease<br>* Adult patients admitted to the UMAE Specialty Hospital of CMN SXXI with a diagnosis of COVID-19. The diagnosis must be corroborated by the RT-PCR test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of cytokines and chemokines | Pg/ml of IL-2, CXCL8 / IL-8,IL-4, CCL5 / RANTES, IL-6, CXCL9 / MIG, IL-10, CCL2 / MCP-1, TNF-alfa, CXCL10 / IP-10, IFN-alfa, soluble receptor IL6, IFN-gamma. | Day 0 | 
| Serum levels of cytokines and chemokines | Pg/ml of IL-2, CXCL8 / IL-8,IL-4, CCL5 / RANTES, IL-6, CXCL9 / MIG, IL-10, CCL2 / MCP-1, TNF-alfa, CXCL10 / IP-10, IFN-alfa, soluble receptor IL6, IFN-gamma. | Day 3 | 
| Serum levels of cytokines and chemokines | Pg/ml of IL-2, CXCL8 / IL-8,IL-4, CCL5 / RANTES, IL-6, CXCL9 / MIG, IL-10, CCL2 / MCP-1, TNF-alfa, CXCL10 / IP-10, IFN-alfa, soluble receptor IL6, IFN-gamma. | Day 7 | 
| Viral load | log10 U/ml | Day 0 | 
| Viral load | log10 U/ml | Day 7 | 
| Immunophenotype of myeloid cells | Immunophenotypic profile of myeloid cells in COVID by surface molecules CD45, CD14, CD16, mIL-6R, CD73 and CD3. reported in relative fluorescence units and relative percentage of cells analyzed by flow cytometry | Day 0 | 
| Immunophenotype of myeloid cells | Immunophenotypic profile of myeloid cells in COVID by surface molecules CD45, CD14, CD16, mIL-6R, CD73 and CD3. reported in relative fluorescence units and relative percentage of cells analyzed by flow cytometry | Day 3 | 
| Immunophenotype of myeloid cells | Immunophenotypic profile of myeloid cells in COVID by surface molecules CD45, CD14, CD16, mIL-6R, CD73 and CD3. reported in relative fluorescence units and relative percentage of cells analyzed by flow cytometry | Day 7 | 
| RBD-SARS-CoV Protein S- antibodies | relative absorbance units by ELISA | Day 0 | 
| RBD-SARS-CoV Protein S- antibodies | relative absorbance units by ELISA | Day 3 | 
| RBD-SARS-CoV Protein S- antibodies | relative absorbance units by ELISA | Day 7 | 
| Analysis of cellular immune response | Cell count per area (/ mm2) of immune cell sub-populations | Day 0 | 
| Analysis of cellular immune response | Cell count per area (/ mm2) of immune cell sub-populations | Day 3 | 
| Analysis of cellular immune response | Cell count per area (/ mm2) of immune cell sub-populations | Day 7 | 
| Hematopoietic stem cells and progenitor cells populations in peripheral blood | Immunophenotypic profile of stem cells and progenitor cells populations COVID by surface molecules CD34, CD38, CD45RA, Lin, CD3, CD8, CD56, CD19, CD20, CD11b, CD235a andCD14. reported in relative fluorescence units and relative percentage of cells, analyzed by flow cytometry | Day 0 | 
| Hematopoietic stem cells and progenitor cells populations in peripheral blood | Immunophenotypic profile of stem cells and progenitor cells populations COVID by surface molecules CD34, CD38, CD45RA, Lin, CD3, CD8, CD56, CD19, CD20, CD11b, CD235a andCD14. reported in relative fluorescence units and relative percentage of cells, analyzed by flow cytometry | Day 3 | 
| Hematopoietic stem cells and progenitor cells populations in peripheral blood | Immunophenotypic profile of stem cells and progenitor cells populations COVID by surface molecules CD34, CD38, CD45RA, Lin, CD3, CD8, CD56, CD19, CD20, CD11b, CD235a andCD14. reported in relative fluorescence units and relative percentage of cells, analyzed by flow cytometry | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire of Sociodemographic, labor, pathological and personal characteristics | Questionnaire | Day 0 | 
| SOFA (Secuential Organ Failure Assessment Score) | Is used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. | Day 0 | 
| SOFA (Secuential Organ Failure Assessment Score) | Is used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. | Day 3 | 
| SOFA (Secuential Organ Failure Assessment Score) | Is used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. | Day 7 | 
| Fibrinogen | mg/dL | Day 0 | 
| Fibrinogen | mg/dL | Day 3 | 
| Fibrinogen | mg/dL | Day 7 | 
| C-Reactive protein | mg/L | Day 0 | 
| C-Reactive protein | mg/L | Day 3 | 
| C-Reactive protein | mg/L | Day 7 |