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OpenTrials
Completed

NCT Number: NCT04766294

Macrophage Activation Markers in COVID-19 Patients

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

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Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine - sohag university

Sohag, 82524, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. Measurement of matrix metalloproteinase-7 "MMP-7" serum level (pg/ml) as a biomarker of macrophage activation

    Time frame: 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.

  2. Measurement of matrix metalloproteinase-9 "MMP-9" serum level (pg/L) as a biomarker of macrophage activation

    Time frame: 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.

  3. Measurement of transforming growth factor B "TGF-B" serum level ( pg/ml) as a biomarker of macrophage activation

    Time frame: 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.

  4. Measurement of platelet derived growth factor "PDGF" serum level (ng/ml) as a biomarker of macrophage activation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study 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?

Acronym: COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2021
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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