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

Sponsor

Benha University (Other)

Overall Status

Completed

CT.gov ID

NCT05408325

Collaborator

(none)

100

Enrollment

Location

12.4

Actual Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Cytokine Storm

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

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Actual Primary Completion Date :

Dec 30, 2021

Actual Study Completion Date :

Feb 12, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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.