Corona Virus InfectionNCT04583566
Differential Expression of Cytokines, Transcriptome and miRNA in Coronavirus Disease 2019 (COVID-19) Egyptian's Patients
An observational study of Corona Virus Infection, run by Tanta University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection
- What is being tested?
- COVID-19 Diagnostic and Assessment Tests
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 4 Oct 2020to 3 Oct 2022
- How long will I take part?
- 2 Months
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Confirmed COVID-19 Patients, and patients aged above 18 will be considered in this project.
Who cannot join
- Patients with more than one of these chronic diseases; diabetes mellitus, hypertension, cardiac diseases, and livers diseases grade 2 and 3 will be excluded.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Recruiting
Tanta University Hospital
Tanta, El Gharbia, 31527
Mohammed Hanteera, Professor, +201141146700, mohamed.hantera@med.tanta.edu.eg
- Completed
Center of Excellence in Cancer Research, Tanta University Hospital.
Tanta, Gharbia Governorate, 31527
About this study
Official title: Studies on the Differential Expression of Cytokines, Transcriptome and miRNA in the Context of COVID-19 Infection in Egyptian Community
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.
Read the detailed 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.
- Conditions
- Corona Virus Infection
- Being tested
- COVID-19 Diagnostic and Assessment Tests
- Keywords
- COVID-19, Cytokines Storm, miRNA, Transcriptome, Microarray
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 Diagnostic and Assessment TestsGenetic
Complete Blood Count (CBC), Differential leukocytes, D-dimer, C-Reactive Protein, Polymerase Chain Reaction (PCR) Test, Ferritin level, Cytokines Profile, Transcriptome Analysis, miRNA Analysis.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Severe Symptoms | Patients with severe symptoms need oxygen and ventilation. Receives: 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 Receives: Genetic: COVID-19 Diagnostic and Assessment Tests | |
| Control Healthy | Healthy group with out any infection or symptoms. Receives: Genetic: COVID-19 Diagnostic and Assessment Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.).
Measured: 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.).
Measured: 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.).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start4 Oct 2020
- Primary completion3 Oct 2021 (estimated)
- Study completion3 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ali Ahmed Eid, Tanta University
- Investigators
- Mohammed Eid, Doctor, Principal investigator, Botany and Microbiology Department, Faculty of Science, Tanta University Tanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583566
- Sponsor's protocol ID
- CTM_COVID-19
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on the Differential Expression of Cytokines, Transcriptome and miRNA in the Context of COVID-19 Infection in Egyptian Community
- ClinicalTrials.gov ID
- NCT04583566
- Acronym / sponsor ID
- CTM_COVID-19
- Conditions
- Corona Virus Infection
- Keywords
- COVID-19, Cytokines Storm, miRNA, Transcriptome, Microarray
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 4 Oct 2020 (actual)
- Primary completion
- 3 Oct 2021 (estimated)
- Study completion
- 3 Oct 2022 (estimated)
- First posted
- 12 Oct 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 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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Severe Symptoms | – | Genetic: COVID-19 Diagnostic and Assessment TestsPatients with severe symptoms need oxygen and ventilation. |
| COVID-19 Mild Symptoms | – | Genetic: COVID-19 Diagnostic and Assessment TestsPatients with moderate symptoms, like normal flu symptoms. They do not need oxygen or ventilation |
| Control Healthy | – | Genetic: COVID-19 Diagnostic and Assessment TestsHealthy group with out any infection or symptoms. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Confirmed COVID-19 Patients, and patients aged above 18 will be considered in this project.
Key exclusion criteria (1 listed)
- Patients with more than one of these chronic diseases; diabetes mellitus, hypertension, cardiac diseases, and livers diseases grade 2 and 3 will be excluded.
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 |
|---|---|---|
| COVID-19 Diagnostic and Assessment TestsComplete Blood Count (CBC), Differential leukocytes, D-dimer, C-Reactive Protein, Polymerase Chain Reaction (PCR) Test, Ferritin level, Cytokines Profile, Transcriptome Analysis, miRNA Analysis. | Genetic | COVID-19 Mild Symptoms, COVID-19 Severe Symptoms, Control Healthy |
Primary outcome
Differential gene expression profile.
Time frame: 3 months
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.).
Differential miRNA expression profile.
Time frame: 3 months
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.).
Multiplex Cytokine assay
Time frame: 3 months
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.).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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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.
Mohammed Eid, Doctor principal investigator
Botany and Microbiology Department, Faculty of Science, Tanta University Tanta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corona Virus Infection, run by Tanta University at 2 sites in Egypt.
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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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 Mohammed El Shanshoury, Professor (+201005680834, elshanshory@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential gene expression profile. (time frame: 3 months). The study lists 3 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 14 Oct 2020.