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

Completed

• Conditions: Cytokine Storm; COVID-19

• Registration Number: NCT05408325
• Lead Sponsor: Benha University

Brief 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.

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 Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-12-30
• Study Completion: 2022-02-12
• Status Verified: 2022-06
• Study First Submitted: 2022-06-04
• Study First Submitted QC: 2022-06-04
• Study First Posted: 2022-06-07
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure level of ICAM 1 and TNFα in RT PCR positive COVID 19 patients	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.

Trial Locations

Locations (1)

Benha University hospital; 🇪🇬 Banhā, Kalyobia, Egypt