NCT04766294

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

11 months

First QC Date

February 17, 2021

Last Update Submit

June 22, 2021

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

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

    ELISA "Enzyme linked immunosorbent assay" technique.

    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

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

    ELISA "Enzyme linked immunosorbent assay" technique.

    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

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

    ELISA "Enzyme linked immunosorbent assay" technique.

    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

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

    ELISA "Enzyme linked immunosorbent assay" technique.

    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

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine - sohag university

Sohag, 82524, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nahed Fathallah, lecturer

    Sohag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Medical Microbiology & Immunology department -Faculty of medicine- Sohag university

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 23, 2021

Study Start

April 25, 2020

Primary Completion

March 15, 2021

Study Completion

April 1, 2021

Last Updated

June 24, 2021

Record last verified: 2021-06

Locations

EG(1)