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

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

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.

Study Overview

• Status: Unknown
• Conditions: SARS-CoV-2
• Intervention / Treatment: Other: Active COVID-19 disease

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Constantino López Macías, PhD; Phone Number: 21476 52 55 56276900; Email: constantino.lopez@imss.gob.mx
• Study Contact Backup: Name: Eduardo Ferat-Osorio, PhD; Phone Number: 21476 52 55 56276900; Email: eduardoferat@me.com

Study Locations

• Mexico
  • Ciudad De México
    • México, Ciudad De México, Mexico, 06720
      • Recruiting
      • UMAE Hospital de Especialidades del Centro Médico Nacional Siglo XXI, IMSS.
      • Contact: Suria Loza Jalil, MD; Phone Number: 21547 52 55 56276900; Email: suria_loza@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mexicans, beneficiaries of the IMSS

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID Patients; Diagnosed patients with COVID-19 by PCR	Other: Active COVID-19 disease; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Coordinación de Investigación en Salud, Mexico
• Collaborators: Instituto Mexicano del Seguro Social
• Investigators: Study Chair: Constantino López Macías, PhD, UIMIQ Hospital de especialidades, CMN S.XXI

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): June 15, 2020
• Study Completion (Anticipated): August 15, 2020

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: R-2020, 3601-043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data of outcomes for meta-analysis purposes
• IPD Sharing Time Frame: After publication for 6 months
• IPD Sharing Access Criteria: Data for meta-analysis purposes, the review requests will be done by the responsible of the research.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No