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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)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04423640
Enrollment
200
Registered
2020-06-09
Start date
2020-04-15
Completion date
2020-08-15
Last updated
2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2

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.

Interventions

OTHERActive 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.

Sponsors

Instituto Mexicano del Seguro Social
CollaboratorOTHER_GOV
Coordinación de Investigación en Salud, Mexico
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hematopoietic stem cells and progenitor cells populations in peripheral bloodDay 0Immunophenotypic 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
Viral loadDay 0log10 U/ml
Immunophenotype of myeloid cellsDay 0Immunophenotypic 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- antibodiesDay 0relative absorbance units by ELISA
Analysis of cellular immune responseDay 0Cell count per area (/ mm2) of immune cell sub-populations
Serum levels of cytokines and chemokinesDay 0Pg/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.

Secondary

MeasureTime frameDescription
SOFA (Secuential Organ Failure Assessment Score)Day 0Is 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.
FibrinogenDay 0mg/dL
C-Reactive proteinDay 0mg/L
Questionnaire of Sociodemographic, labor, pathological and personal characteristicsDay 0Questionnaire

Countries

Mexico

Contacts

Primary ContactConstantino López Macías, PhD
constantino.lopez@imss.gob.mx52 55 56276900
Backup ContactEduardo Ferat-Osorio, PhD
eduardoferat@me.com52 55 56276900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026