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

August 12, 2020 updated by: Coordinación de Investigación en Salud, Mexico

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum levels of cytokines and chemokines
Time Frame: Day 0
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
Time Frame: Day 3
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
Time Frame: 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.
Day 7
Viral load
Time Frame: Day 0
log10 U/ml
Day 0
Viral load
Time Frame: Day 7
log10 U/ml
Day 7
Immunophenotype of myeloid cells
Time Frame: Day 0
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
Time Frame: Day 3
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
Time Frame: 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
Day 7
RBD-SARS-CoV Protein S- antibodies
Time Frame: Day 0
relative absorbance units by ELISA
Day 0
RBD-SARS-CoV Protein S- antibodies
Time Frame: Day 3
relative absorbance units by ELISA
Day 3
RBD-SARS-CoV Protein S- antibodies
Time Frame: Day 7
relative absorbance units by ELISA
Day 7
Analysis of cellular immune response
Time Frame: Day 0
Cell count per area (/ mm2) of immune cell sub-populations
Day 0
Analysis of cellular immune response
Time Frame: Day 3
Cell count per area (/ mm2) of immune cell sub-populations
Day 3
Analysis of cellular immune response
Time Frame: Day 7
Cell count per area (/ mm2) of immune cell sub-populations
Day 7
Hematopoietic stem cells and progenitor cells populations in peripheral blood
Time Frame: Day 0
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
Time Frame: Day 3
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
Time Frame: 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
Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Questionnaire of Sociodemographic, labor, pathological and personal characteristics
Time Frame: Day 0
Questionnaire
Day 0
SOFA (Secuential Organ Failure Assessment Score)
Time Frame: Day 0
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)
Time Frame: Day 3
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)
Time Frame: 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.
Day 7
Fibrinogen
Time Frame: Day 0
mg/dL
Day 0
Fibrinogen
Time Frame: Day 3
mg/dL
Day 3
Fibrinogen
Time Frame: Day 7
mg/dL
Day 7
C-Reactive protein
Time Frame: Day 0
mg/L
Day 0
C-Reactive protein
Time Frame: Day 3
mg/L
Day 3
C-Reactive protein
Time Frame: Day 7
mg/L
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Coordinación de Investigación en Salud, Mexico

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto Mexicano del Seguro Social

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Constantino López Macías, PhD, UIMIQ Hospital de especialidades, CMN S.XXI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

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