COVID-19NCT05408325
Intercellular Adhesion Molecule-1 and TNF-α in Patients With COVID-19
An observational study of COVID-19 and Cytokine Storm, run by Benha University at 1 site in Egypt.
Trial summary
This study aimed to assess the cytokine profile in COVID 19 patients and its relation with disease progression \& severity using COVID reporting and data system (CORADS) score. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19, Cytokine Storm
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 12 Feb 2022
- 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
- Adult, Older adult
Study population: Mild pneumonia was confirmed by positive (qRT-PCR) tests, with no chest tomography features of viral pneumonia, moderate cases had pneumonia in CT chest while severe pneumonia was diagnosed as pneumonia plus 1 of these criteria: (1) respiratory rate ≥ 30 breath per minute with respiratory distress ;(2) saturation of oxygen ≤ 92 % at rest; (3) index of oxygenation ≤ 300 mmHg; (4) respiratory failure that require ventilation;(5) shock; and(6) admission to the ICU unit for other organ failure. CORAD score was calculated for all cases and was included in the radiology report. The degree of suspicion ranged from very low to very high (CO-RADS categories 1-5), while category 0 reflects negative infection and category 6 establishes RT-PCR-positive SARS-Cov-2 infection at time of examination 13.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Levels of Intercellular Adhesion Molecule-1 and TNF-α in Patients With COVID-19 and Its Relation to Disease Severity
This study aimed to assess the cytokine profile in COVID 19 patients and its relation with disease progression \& severity using COVID reporting and data system (CORADS) score.
Read the detailed description
Study Participants This was a prospective case control study done from February to December 2021, 50 COVID19 patients and 50 control participants after taking their written consents were recruited from the emergency department and outpatient clinic to the Medical microbiology and immunology department and infection control unit in Benha university hospital, Benha, Egypt.
Blood samples were taken at admission from each patient and repeated during the convalescence period for severe pneumonic cases. Serum C-reaction protein (CRP), D-dimer, lipids and glucose were determined by conventional laboratory methods. Blood samples of the control group were also collected and tested. The obtained blood samples were placed in tubes containing EDTA and blank tubes then immediately centrifuged at 1500g and stored at -80°C.
Enzyme-Linked Immunosorbent Assay Quantitative detection for tumor necrosis factor alfa (TNF-α) \& intercellular adhesion molecule1 (ICAM-1) was performed using ELISA kits ( Bio reader by thermo fisher scientific Waltham, MA USA) according to the manufacture instructions.
Statistical analysis Data were analysed using SPSS software, version 25.0 (IBM, Armonk, NY, USA) for Windows. Quantitative data were tested for normality using Kolomograph test assuming normality at P>0.05. they were proved to be non parametric, so they were presented as median and inter-quartile range (IQR), and analyzed by Man Whitney U test and Kruskal Wallis (KW) test for independent groups. P ≤0.05 was considered significant
P value >0.05 insignificant P≤0.05 significant P<0.001 highly significant
- Conditions
- COVID-19, Cytokine Storm
- Keywords
- Covid19, ICAM, Cytokines, TNF
- Medical subject headings
- COVID-19, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| confirmed COVID 19 ptients | All patients confirmed by RT-PCR, as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who visited the emergency room and the outpatient clinic in the study period. | |
| healthy subjects | normal healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure level of ICAM 1 and TNFα in RT PCR positive COVID 19 patients
Quantitative detection for tumor necrosis factor alfa (TNF-α) \& intercellular adhesion molecule1 (ICAM-1) was performed using ELISA kits ( Bio reader by thermo fisher scientific Waltham, MA USA) according to the manufacture instructions.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Feb 2021
- Primary completion30 Dec 2021
- Study completion12 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Benha 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMIRA HUSSEIN ALLAM, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408325
- Sponsor's protocol ID
- TEJB-D-22-00066
- Status last verified
- Jun 2022
- First submitted
- 4 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Levels of Intercellular Adhesion Molecule-1 and TNF-α in Patients With COVID-19 and Its Relation to Disease Severity
- ClinicalTrials.gov ID
- NCT05408325
- Acronym / sponsor ID
- TEJB-D-22-00066
- Conditions
- COVID-19, Cytokine Storm
- Keywords
- Covid19, ICAM, Cytokines, TNF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 12 Feb 2022 (actual)
- First posted
- 7 Jun 2022 (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.
This study aimed to assess the cytokine profile in COVID 19 patients and its relation with disease progression \& severity using COVID reporting and data system (CORADS) score.
Detailed description
Study Participants This was a prospective case control study done from February to December 2021, 50 COVID19 patients and 50 control participants after taking their written consents were recruited from the emergency department and outpatient clinic to the Medical microbiology and immunology department and infection control unit in Benha university hospital, Benha, Egypt.
Blood samples were taken at admission from each patient and repeated during the convalescence period for severe pneumonic cases. Serum C-reaction protein (CRP), D-dimer, lipids and glucose were determined by conventional laboratory methods. Blood samples of the control group were also collected and tested. The obtained blood samples were placed in tubes containing EDTA and blank tubes then immediately centrifuged at 1500g and stored at -80°C.
Enzyme-Linked Immunosorbent Assay Quantitative detection for tumor necrosis factor alfa (TNF-α) \& intercellular adhesion molecule1 (ICAM-1) was performed using ELISA kits ( Bio reader by thermo fisher scientific Waltham, MA USA) according to the manufacture instructions.
Statistical analysis Data were analysed using SPSS software, version 25.0 (IBM, Armonk, NY, USA) for Windows. Quantitative data were tested for normality using Kolomograph test assuming normality at P>0.05. they were proved to be non parametric, so they were presented as median and inter-quartile range (IQR), and analyzed by Man Whitney U test and Kruskal Wallis (KW) test for independent groups. P ≤0.05 was considered significant
P value >0.05 insignificant P≤0.05 significant P<0.001 highly significant
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| confirmed COVID 19 ptients | – | –All patients confirmed by RT-PCR, as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who visited the emergency room and the outpatient clinic in the study period. |
| healthy subjects | – | –normal healthy volunteers |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Mild pneumonia was confirmed by positive (qRT-PCR) tests, with no chest tomography features of viral pneumonia, moderate cases had pneumonia in CT chest while severe pneumonia was diagnosed as pneumonia plus 1 of these criteria: (1) respiratory rate ≥ 30 breath per minute with respiratory distress ;(2) saturation of oxygen ≤ 92 % at rest; (3) index of oxygenation ≤ 300 mmHg; (4) respiratory failure that require ventilation;(5) shock; and(6) admission to the ICU unit for other organ failure. CORAD score was calculated for all cases and was included in the radiology report. The degree of suspicion ranged from very low to very high (CO-RADS categories 1-5), while category 0 reflects negative infection and category 6 establishes RT-PCR-positive SARS-Cov-2 infection at time of examination 13.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure level of ICAM 1 and TNFα in RT PCR positive COVID 19 patients
Time frame: 12 month
Quantitative detection for tumor necrosis factor alfa (TNF-α) \& intercellular adhesion molecule1 (ICAM-1) was performed using ELISA kits ( Bio reader by thermo fisher scientific Waltham, MA USA) according to the manufacture instructions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 and Cytokine Storm, run by Benha University at 1 site 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 0 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: finished, as of the sponsor's last update on 14 Jun 2022. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure level of ICAM 1 and TNFα in RT PCR positive COVID 19 patients (time frame: 12 month). 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 Jun 2022.