Intercellular Adhesion Molecule-1 and TNF-α in Patients With COVID-19

COVID-19 Clinical Trial

Official title:

Serum Levels of Intercellular Adhesion Molecule-1 and TNF-α in Patients With COVID-19 and Its Relation to Disease Severity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408325
• Other study ID #: TEJB-D-22-00066
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: February 12, 2022

Study information

• Verified date: June 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 12, 2022
• Est. primary completion date: December 30, 2021
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria: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. The control group included 50 healthy volunteers.

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Exclusion Criteria:

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Related Conditions & MeSH terms

• COVID-19
• Cytokine Release Syndrome
• Cytokine Storm

Locations

Country	Name	City	State
Egypt	Benha University hospital	Banha	Kalyobia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure level of ICAM 1 and TNFa in RT PCR positive COVID 19 patients	Quantitative detection for tumor necrosis factor alfa (TNF-a) & intercellular adhesion molecule1 (ICAM-1) was performed using ELISA kits ( Bio reader by thermo fisher scientific Waltham, MA USA) according to the manufacture instructions.	12 month