Clinical trial NCT04766294: Macrophage Activation Markers in COVID-19 Patients
Official title: Is the Severity of COVID-19 in Obese and Diabetic Patients Linked to High Serum Levels of MMP-7, MMP-9, TGF-β and PDGF Macrophage Activation Markers?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: COVID-19 patients admitted to isolation hospital in Sohag "Sohag teaching hospital".

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Measurement of matrix metalloproteinase-7 "MMP-7" serum level (pg/ml) as a biomarker of macrophage activation
timeFrame: 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
measure: Measurement of matrix metalloproteinase-9 "MMP-9" serum level (pg/L) as a biomarker of macrophage activation
timeFrame: 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
measure: Measurement of transforming growth factor B "TGF-B" serum level ( pg/ml) as a biomarker of macrophage activation
timeFrame: 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
measure: Measurement of platelet derived growth factor "PDGF" serum level (ng/ml) as a biomarker of macrophage activation
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine - sohag university
Study officials:
affiliation: Sohag University
name: Nahed Fathallah, lecturer
role: PRINCIPAL_INVESTIGATOR
References: