Differential Expression of Cytokines, Transcriptome and miRNA in Coronavirus Disease 2019 (COVID-19) Egyptian's Patients

NCT04583566 | Unknown DMC

• 1 other identifier: CTM_COVID-19
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this effort is to study host-pathogen interaction in Egyptian patients infected with COVID-19. The investigators will perform genome-wide miRNA and transcriptome screens in the infected patients along with healthy ones for comparison. All types of cytokines play pivotal roles in immunity, including the responses to different viral infections. Therefore, The investigators will study the cytokines profile in response to that infection. By comparing miRNA and transcriptome screens along with cytokines profiles, an important molecule might be identified that could play role in the inhibition of the COVID-19 outbreak. In addition, this information will help us gaining awareness of the immune process and knowing about the genes involved in the immune response against COVID-19 with an emphasis on the expression of cytokines.

Conditions

Corona Virus Infection

Keywords

COVID-19; Cytokines Storm; miRNA; Transcriptome; Microarray

Outcome Measures

Primary Outcomes (3)

• Differential gene expression profile.

  The investigators will analysis total gene expression profile between 15 sever and 15 moderate COVID-19 patients in comparison to 10 health ones by using Affymetrix® Microarray Technology. Microarray raw data for whole transcriptome will be extracted and processed for analysis (about 25000 genes) using different software packages in order to dissect the differential expressions that will be correlated to the clinical data; for example (CBC, D-dimer value, ferritin value…..etc.).

  3 months

• Differential miRNA expression profile.

  The investigators will analysis total miRNA expression profile between 15 sever and 15 moderate COVID-19 patients in comparison to 10 health ones by using Affymetrix® Microarray Technology. Microarray raw data for whole miRNA expression will be extracted and processed for analysis using different software packages in order to dissect the differential expressions that will be correlated to the clinical data; for example (CBC, D-dimer value, ferritin value…..etc.).

  3 months

• Multiplex Cytokine assay

  This assay will be done on plasma of patients. The investigators will analysis the different cytokine profile between 15 sever and 15 moderate COVID-19 patients in comparison to 10 health ones by using xMAP (Multi-Analyte Profiling) technology \& Luminex 200. The obtained data will be analyzed using statistical software to study the different profile between the selected participants. The obtained data will be also correlated to the clinical data; for example (CBC, D-dimer value, ferritin value…..etc.).

  3 months

Study Arms (3)

COVID-19 Severe Symptoms

Patients with severe symptoms need oxygen and ventilation.

Genetic: COVID-19 Diagnostic and Assessment Tests

COVID-19 Mild Symptoms

Patients with moderate symptoms, like normal flu symptoms. They do not need oxygen or ventilation

Genetic: COVID-19 Diagnostic and Assessment Tests

Control Healthy

Healthy group with out any infection or symptoms.

Genetic: COVID-19 Diagnostic and Assessment Tests

Interventions

COVID-19 Diagnostic and Assessment Tests GENETIC

Complete Blood Count (CBC), Differential leukocytes, D-dimer, C-Reactive Protein, Polymerase Chain Reaction (PCR) Test, Ferritin level, Cytokines Profile, Transcriptome Analysis, miRNA Analysis.

COVID-19 Mild Symptoms; COVID-19 Severe Symptoms; Control Healthy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The bioinformatics and statistical analyses will be done to differentiat the actual gene expression, miRNA expression, and cytokine storm profile between severe, and mild, COVID-19 patients in comparison to health control.

You may qualify if:

• Confirmed COVID-19 Patients, and patients aged above 18 will be considered in this project.

You may not qualify if:

• Patients with more than one of these chronic diseases; diabetes mellitus, hypertension, cardiac diseases, and livers diseases grade 2 and 3 will be excluded.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (2)

Tanta University Hospital

Tanta, El Gharbia, 31527, Egypt

RECRUITING

Center of Excellence in Cancer Research, Tanta University Hospital.

Tanta, Gharbia Governorate, 31527, Egypt

COMPLETED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mohammed Eid, Doctor

  Botany and Microbiology Department, Faculty of Science, Tanta University Tanta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed El Shanshoury, Professor

CONTACT

+201005680834; elshanshory@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mohammed Eid

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 12, 2020
• Study Start: October 4, 2020
• Primary Completion: October 3, 2021
• Study Completion: October 3, 2022
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

EG (2)