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

• Conditions: SARS-CoV-2
• Interventions: Other: Active COVID-19 disease

• Registration Number: NCT04423640
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-15
• Status Verified: 2020-05
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-09
• Primary Completion: 2020-06-15
• Last Update Submitted: 2020-08-12
• Last Update Posted: 2020-08-13
• Study Completion: 2020-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID Patients	Active COVID-19 disease	Diagnosed patients with COVID-19 by PCR

Primary Outcome Measures

Name	Time	Method
Serum levels of cytokines and chemokines	Day 7	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.
Viral load	Day 7	log10 U/ml
Analysis of cellular immune response	Day 7	Cell count per area (/ mm2) of immune cell sub-populations
Hematopoietic stem cells and progenitor cells populations in peripheral blood	Day 7	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
Immunophenotype of myeloid cells	Day 7	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
RBD-SARS-CoV Protein S- antibodies	Day 7	relative absorbance units by ELISA

Secondary Outcome Measures

Name	Time	Method
Questionnaire of Sociodemographic, labor, pathological and personal characteristics	Day 0	Questionnaire
SOFA (Secuential Organ Failure Assessment Score)	Day 7	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.
Fibrinogen	Day 7	mg/dL
C-Reactive protein	Day 7	mg/L

Trial Locations

Locations (1)

UMAE Hospital de Especialidades del Centro Médico Nacional Siglo XXI, IMSS.; 🇲🇽 México, Ciudad De México, Mexico