Clinical trial NCT04423640: Analysis of the Inflammatory Response and the Development of Humoral and Cellular Immunity in Patients With COVID-19
Official title: The Analysis of the Inflammatory Response and the Development of Humoral and Cellular Immunity in Patients With Coronavirus Disease 2019 (COVID-19)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Mexicano del Seguro Social
First posted: 2020-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mexicans, beneficiaries of the IMSS

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serum levels of cytokines and chemokines
timeFrame: Day 0
measure: Serum levels of cytokines and chemokines
timeFrame: Day 3
measure: Serum levels of cytokines and chemokines
timeFrame: Day 7
measure: Viral load
timeFrame: Day 0
measure: Viral load
timeFrame: Day 7
measure: Immunophenotype of myeloid cells
timeFrame: Day 0
measure: Immunophenotype of myeloid cells
timeFrame: Day 3
measure: Immunophenotype of myeloid cells
timeFrame: Day 7
measure: RBD-SARS-CoV Protein S- antibodies
timeFrame: Day 0
measure: RBD-SARS-CoV Protein S- antibodies
timeFrame: Day 3
measure: RBD-SARS-CoV Protein S- antibodies
timeFrame: Day 7
measure: Analysis of cellular immune response
timeFrame: Day 0
measure: Analysis of cellular immune response
timeFrame: Day 3
measure: Analysis of cellular immune response
timeFrame: Day 7
measure: Hematopoietic stem cells and progenitor cells populations in peripheral blood
timeFrame: Day 0
measure: Hematopoietic stem cells and progenitor cells populations in peripheral blood
timeFrame: Day 3
measure: Hematopoietic stem cells and progenitor cells populations in peripheral blood
timeFrame: Day 7
Secondary outcomes:
measure: Questionnaire of Sociodemographic, labor, pathological and personal characteristics
timeFrame: Day 0
measure: SOFA (Secuential Organ Failure Assessment Score)
timeFrame: Day 0
measure: SOFA (Secuential Organ Failure Assessment Score)
timeFrame: Day 3
measure: SOFA (Secuential Organ Failure Assessment Score)
timeFrame: Day 7
measure: Fibrinogen
timeFrame: Day 0
measure: Fibrinogen
timeFrame: Day 3
measure: Fibrinogen
timeFrame: Day 7
measure: C-Reactive protein
timeFrame: Day 0
measure: C-Reactive protein
timeFrame: Day 3
measure: C-Reactive protein
timeFrame: Day 7
Other outcomes:
Locations:
city: México
country: Mexico
facility: UMAE Hospital de Especialidades del Centro Médico Nacional Siglo XXI, IMSS.
state: Ciudad De México
Study officials:
affiliation: UIMIQ Hospital de especialidades, CMN S.XXI
name: Constantino López Macías, PhD
role: STUDY_CHAIR
References: