SARS-CoV-2NCT04423640
Analysis of the Inflammatory Response and the Development of Humoral and Cellular Immunity in Patients With COVID-19
An observational study of SARS-CoV-2, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Active COVID-19 disease
- How many people
- 200 participants
- Where
- 1 siteMexico
- Study dates
- 15 Apr 2020to 15 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mexicans, beneficiaries of the IMSS
Who may be able to join
- Patients over 16 years old with positive molecular diagnosis of Covid-19, in the Laboratory of IMSS
Who cannot join
- Patients with immunosuppressive diseases: HIV +, Hepatitis C virus, primary immunodeficiencies, rheumatoid arthritis, lupus erythematosus and patients under treatment with immunosuppressants
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
UMAE Hospital de Especialidades del Centro Médico Nacional Siglo XXI, IMSS.
Mexico City, Mexico City, 06720
Suria Loza Jalil, MD, 52 55 56276900 ext. 21547, suria_loza@yahoo.com
About this study
Official title: 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.
- Conditions
- SARS-CoV-2
- Being tested
- Active COVID-19 disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active COVID-19 diseaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| COVID Patients | Diagnosed patients with COVID-19 by PCR Receives: Other: Active COVID-19 disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
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.
Measured: Day 3
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.
Measured: Day 7
Viral load
log10 U/ml
Measured: Day 0
Viral load
log10 U/ml
Measured: Day 7
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
Measured: Day 0
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
Measured: Day 3
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
Measured: Day 7
RBD-SARS-CoV Protein S- antibodies
relative absorbance units by ELISA
Measured: Day 0
RBD-SARS-CoV Protein S- antibodies
relative absorbance units by ELISA
Measured: Day 3
RBD-SARS-CoV Protein S- antibodies
relative absorbance units by ELISA
Measured: Day 7
Analysis of cellular immune response
Cell count per area (/ mm2) of immune cell sub-populations
Measured: Day 0
Analysis of cellular immune response
Cell count per area (/ mm2) of immune cell sub-populations
Measured: Day 3
Analysis of cellular immune response
Cell count per area (/ mm2) of immune cell sub-populations
Measured: Day 7
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
Measured: Day 0
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
Measured: Day 3
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
Measured: Day 7
Secondary outcomes (10)
Questionnaire of Sociodemographic, labor, pathological and personal characteristics
Questionnaire
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 3
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.
Measured: Day 7
Fibrinogen
mg/dL
Measured: Day 0
Fibrinogen
mg/dL
Measured: Day 3
Fibrinogen
mg/dL
Measured: Day 7
C-Reactive protein
mg/L
Measured: Day 0
C-Reactive protein
mg/L
Measured: Day 3
C-Reactive protein
mg/L
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start15 Apr 2020
- Primary completion15 Jun 2020
- Study completion15 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- Instituto Mexicano del Seguro Social
- Responsible party
- Sponsor
- Investigators
- Constantino López Macías, PhD, Study chair, UIMIQ Hospital de especialidades, CMN S.XXI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423640
- Sponsor's protocol ID
- R-2020, 3601-043
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data of outcomes for meta-analysis purposes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analysis of the Inflammatory Response and the Development of Humoral and Cellular Immunity in Patients With Coronavirus Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04423640
- Acronym / sponsor ID
- R-2020, 3601-043
- Conditions
- SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- Instituto Mexicano del Seguro Social
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Aug 2020 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID Patients | – | Other: Active COVID-19 diseaseDiagnosed patients with COVID-19 by PCR |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mexicans, beneficiaries of the IMSS
Key inclusion criteria (1 listed)
- Patients over 16 years old with positive molecular diagnosis of Covid-19, in the Laboratory of IMSS
Key exclusion criteria (1 listed)
- Patients with immunosuppressive diseases: HIV +, Hepatitis C virus, primary immunodeficiencies, rheumatoid arthritis, lupus erythematosus and patients under treatment with immunosuppressants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active COVID-19 diseaseAdult 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. | Other | COVID Patients |
Primary outcome
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.
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.
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.
Viral load
Time frame: Day 0
log10 U/ml
Viral load
Time frame: Day 7
log10 U/ml
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
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
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
RBD-SARS-CoV Protein S- antibodies
Time frame: Day 0
relative absorbance units by ELISA
RBD-SARS-CoV Protein S- antibodies
Time frame: Day 3
relative absorbance units by ELISA
RBD-SARS-CoV Protein S- antibodies
Time frame: Day 7
relative absorbance units by ELISA
Analysis of cellular immune response
Time frame: Day 0
Cell count per area (/ mm2) of immune cell sub-populations
Analysis of cellular immune response
Time frame: Day 3
Cell count per area (/ mm2) of immune cell sub-populations
Analysis of cellular immune response
Time frame: Day 7
Cell count per area (/ mm2) of immune cell sub-populations
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
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
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
10 secondary outcomes
Questionnaire of Sociodemographic, labor, pathological and personal characteristics
Time frame: Day 0
SOFA (Secuential Organ Failure Assessment Score)
Time frame: Day 0
SOFA (Secuential Organ Failure Assessment Score)
Time frame: Day 3
SOFA (Secuential Organ Failure Assessment Score)
Time frame: Day 7
Fibrinogen
Time frame: Day 0
Fibrinogen
Time frame: Day 3
Fibrinogen
Time frame: Day 7
C-Reactive protein
Time frame: Day 0
C-Reactive protein
Time frame: Day 3
C-Reactive protein
Time frame: Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Individual participant dataSharing planned: Yes. Data of outcomes for meta-analysis purposes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constantino López Macías, PhD study chair
UIMIQ Hospital de especialidades, CMN S.XXI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Constantino López Macías, PhD (52 55 56276900 ext. 21476, constantino.lopez@imss.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of cytokines and chemokines (time frame: Day 0). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.