NCT04948515

Brief Summary

rates are in such considerable amount among large population base. The pathogenesis of COVID-19 implicates a potent inflammatory response, involving a complex group of mediators including interleukins. These pleiotropic cytokines are secreted at the region of inflammation and released into the circulation by a variety of different cell types, including macrophages, lymphocytes, endothelial cells, epithelial cells during sepsis and acute organ injuries. There has recently found a number of studies reporting that the cytokine storms take part in the course of COVID-19

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

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

June 3, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2021

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

June 24, 2021

Last Update Submit

October 24, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • genotyping of IL 17

    real time pcr detection of different genotypes

    3-6-2021 to 30-8-2021

  • genotyping of IL 23

    real time pcr detection of different genotypes

    3-6-2021 to 30-8-2021

  • estimation of serum level of IL 17

    measuring serum level of IL 17 by ELISA

    3-6-2021 to 30-8-2021

Study Arms (2)

group 1 patients with severe covid 19 respiratory infections

Patients with severe covid 19 admitted to ICU, blood samples will be collected for testing different genotypes and serum level of IL 17

Diagnostic Test: laboratory test

group 2 patients with non severe covid 19 respiratory infections

Patients with nonsevere covid 19 admitted to the internal ward, blood samples will be collected for testing different genotypes and serum level of IL 17

Diagnostic Test: laboratory test

Interventions

laboratory testDIAGNOSTIC_TEST

genotyping of IL 17 and IL23

group 1 patients with severe covid 19 respiratory infectionsgroup 2 patients with non severe covid 19 respiratory infections

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

group 1 patients with covid 19 with severe infections admitted at ICU group 2 patients with covid 19 with nonsevere infections admitted at internal wards

You may qualify if:

  • Patients with Covid19 positive PCR

You may not qualify if:

  • Patients with Covid19 clinical criteria not confirmed by PCR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, 82733, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood collected on EDITA tubes for genotyping by ELISA and serum blood on plane tubes for ELISA

MeSH Terms

Interventions

Clinical Laboratory Techniques

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • N S shafik, lecturer

    Sohag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 2, 2021

Study Start

June 3, 2021

Primary Completion

November 30, 2021

Study Completion

December 3, 2021

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

to protect the privacy of the patient

Locations