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

NCT ID: NCT04583566

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-04

Study Completion Date

2022-10-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Corona Virus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COVID-19 Severe Symptoms

Patients with severe symptoms need oxygen and ventilation.

COVID-19 Diagnostic and Assessment Tests

Intervention Type 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

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

COVID-19 Diagnostic and Assessment Tests

Intervention Type 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.

Control Healthy

Healthy group with out any infection or symptoms.

COVID-19 Diagnostic and Assessment Tests

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type GENETIC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohammed Ali Ahmed Eid

Dr. Mohammed Eid

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohammed Eid, Doctor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tanta University Hospital

Tanta, El Gharbia, Egypt

Site Status RECRUITING

Center of Excellence in Cancer Research, Tanta University Hospital.

Tanta, Gharbia Governorate, Egypt

Site Status COMPLETED

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohammed El Shanshoury, Professor

Role: CONTACT

+201005680834

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohammed Hanteera, Professor

Role: primary

+201141146700

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTM_COVID-19

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.