Macrophage Activation Markers in COVID-19 Patients

Completed

• Conditions: COVID-19

• Registration Number: NCT04766294
• Lead Sponsor: Sohag University

Brief Summary

This study is aiming to find the relation between the severity of COVID-19 in diabetic and obese patients and the high serum levels of matrix metalloproteinase-7 (MMP-7),matrix metalloproteinase-9 (MMP-9), TGF-β and PDGF Macrophage Activation Markers

Detailed Description

Acute respiratory distress syndrome (ARDS) commonly occurs in COVID-19 patients who are diabetic and obese, ARDS is characterized by inflammation and pulmonary fibrosis mediated by cytokines and biomarkers released from activated alveolar macrophages, also cytokine storm may occurs leading to multiple organ failure. These sequelae of COVID-19 disease in obese and diabetic patients are attributed to elevated plasma lipopolysaccharide which is the main activator of M1 and M2 macrophages. chronic activation of macrophages leads to production of profibrotic markers as transforming growth factor-β (TGF-β), platelet-derived growth factor (PDGF), matrix metalloproteinase-7 (MMP7) and matrix metalloproteinase-9 (MMP9) which promote fibrogenesis. In this research, we measure circulatory alveolar macrophage activation markers in COVID-19 obese patients with type 1 and type 2 diabetes.

Study Timeline

• Study Start: 2020-04-25
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-23
• Primary Completion: 2021-03-15
• Study Completion: 2021-04-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-22
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Overweight patients with body mass index higher than 25 and obese patients with body mass index higher than 30 were selected to be included
• Type one and type two diabetes mellitus patients were also included

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of matrix metalloproteinase-7 "MMP-7" serum level (pg/ml) as a biomarker of macrophage activation	MMP-7 is measured after admission of patients to isolation hospital along 7 days interval for 21 days, 3 plasma samples are collected on the 7th day of admission, day 14 and day 21	ELISA "Enzyme linked immunosorbent assay" technique.
Measurement of matrix metalloproteinase-9 "MMP-9" serum level (pg/L) as a biomarker of macrophage activation	MMP-9 is measured after admission of patients to isolation hospital along 7 days interval for 21 days, 3 plasma samples are collected on the 7th day of admission, day 14 and day 21	ELISA "Enzyme linked immunosorbent assay" technique.
Measurement of transforming growth factor B "TGF-B" serum level ( pg/ml) as a biomarker of macrophage activation	TGF-B is measured after admission of patients to isolation hospital along 7 days interval for 21 days, 3 plasma samples are collected on the 7th day of admission, day 14 and day 21	ELISA "Enzyme linked immunosorbent assay" technique.
Measurement of platelet derived growth factor "PDGF" serum level (ng/ml) as a biomarker of macrophage activation	PDGF is measured after admission of patients to isolation hospital along 7 days interval for 21 days, 3 plasma samples are collected on the 7th day of admission, day 14 and day 21	ELISA "Enzyme linked immunosorbent assay" technique.

Trial Locations

Locations (1)

Faculty of medicine - sohag university; 🇪🇬 Sohag, Egypt