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

Corona Virus Infection Clinical Trial

Official title:

Studies on the Differential Expression of Cytokines, Transcriptome and miRNA in the Context of COVID-19 Infection in Egyptian Community

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04583566
• Other study ID #: CTM_COVID-19
• Status: Recruiting
• Start date: October 4, 2020
• Est. completion date: October 3, 2022

Study information

• Verified date: October 2020
• Source: Tanta University
• Contact: Mohammed El Shanshoury, Professor
• Phone: +201005680834
• Email: elshanshory[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Coronaviruses are a group of viruses that cause diseases in mammals and birds. In humans, coronaviruses cause respiratory tract infections that can be mild, such as some cases of the common cold, and others that can be lethal, such as severe acute respiratory syndrome (SARS), (middle east respiratory syndrome) MERS, and COVID-19. They contain a positive-sense, single-stranded RNA genome. The genome size ranges from approximately 27 to 34 kilobases. It has a 5' methylated cap "5'leader, UTR", replicas/transcriptase enzyme, spike (S) protein, envelope (E) protein, membrane (M) protein, nucleocapsid (N) protein, 3'untranslated region (3'UTR), and a poly (A) tail, respectively. The S protein has a major role in eliciting the protective immunity during infection with SARS-corona virus (SARS-CoV) by inducing neutralizing-antibodies and T-cell responses. It is also the most mutated part of the coronavirus genome. 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, which 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 3, 2022
• Est. primary completion date: October 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Infection
• Severe Acute Respiratory Syndrome

Intervention

Genetic:
• COVID-19 Diagnostic and Assessment Tests
Complete Blood Count (CBC), Differential leukocytes, D-dimer, C-Reactive Protein, Polymerase Chain Reaction (PCR) Test, Ferritin level, Cytokines Profile, Transcriptome Analysis, miRNA Analysis.

Locations

Country	Name	City	State
Egypt	Center of Excellence in Cancer Research, Tanta University Hospital.	Tanta	Gharbia
Egypt	Tanta University Hospital	Tanta	El Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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