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

SARS-CoV-2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423640
• Other study ID #: R-2020, 3601-043
• Status: Recruiting
• Start date: April 15, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: May 2020
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: Constantino López Macías, PhD
• Phone: 52 55 56276900
• Email: constantino.lopez[@]imss.gob.mx
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

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.

Locations

Country	Name	City	State
Mexico	UMAE Hospital de Especialidades del Centro Médico Nacional Siglo XXI, IMSS.	México	Ciudad De México

Sponsors (2)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico	Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Viral load	log10 U/ml	Day 0
Primary	Viral load	log10 U/ml	Day 7
Primary	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
Primary	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
Primary	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
Primary	RBD-SARS-CoV Protein S- antibodies	relative absorbance units by ELISA	Day 0
Primary	RBD-SARS-CoV Protein S- antibodies	relative absorbance units by ELISA	Day 3
Primary	RBD-SARS-CoV Protein S- antibodies	relative absorbance units by ELISA	Day 7
Primary	Analysis of cellular immune response	Cell count per area (/ mm2) of immune cell sub-populations	Day 0
Primary	Analysis of cellular immune response	Cell count per area (/ mm2) of immune cell sub-populations	Day 3
Primary	Analysis of cellular immune response	Cell count per area (/ mm2) of immune cell sub-populations	Day 7
Primary	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
Primary	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
Primary	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	Questionnaire of Sociodemographic, labor, pathological and personal characteristics	Questionnaire	Day 0
Secondary	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
Secondary	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
Secondary	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
Secondary	Fibrinogen	mg/dL	Day 0
Secondary	Fibrinogen	mg/dL	Day 3
Secondary	Fibrinogen	mg/dL	Day 7
Secondary	C-Reactive protein	mg/L	Day 0
Secondary	C-Reactive protein	mg/L	Day 3
Secondary	C-Reactive protein	mg/L	Day 7