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CompletedNCT04766294COVID-19Updated Jun 24, 2021

Macrophage Activation Markers in COVID-19 Patients

An observational study in COVID-19, sponsored by Sohag University. Completed at 1 site in Egypt. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-06-24.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
70
Ages
19 Years to 70 Years
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • COVID-19

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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 70 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

COVID-19 patients admitted to isolation hospital in Sohag "Sohag teaching hospital".

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

Exclusion Criteria:

-

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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
70 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

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

    ELISA "Enzyme linked immunosorbent assay" technique.

    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

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

    ELISA "Enzyme linked immunosorbent assay" technique.

    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

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

    ELISA "Enzyme linked immunosorbent assay" technique.

    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

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

    ELISA "Enzyme linked immunosorbent assay" technique.

    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

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Study locations

1 site
  • Faculty of medicine - sohag university
    Sohag, 82524, Egypt
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04766294
Lead sponsor
Sohag University
Responsible party
Nahed Fathallah Fahmy (lecturer of Medical Microbiology & Immunology department -Faculty of medicine- Sohag university, Sohag University) — Principal investigator
First posted
Feb 23, 2021
Start date
Apr 25, 2020
Primary completion
Mar 15, 2021
Completion
Apr 1, 2021
Last update
Jun 24, 2021

Study contacts

Nahed Fathallah, lecturer
principal investigator · Sohag University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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