NCT05408325

Brief Summary

This study aimed to assess the cytokine profile in COVID 19 patients and its relation with disease progression \& severity using COVID reporting and data system (CORADS) score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

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

February 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

11 months

First QC Date

June 4, 2022

Last Update Submit

June 10, 2022

Conditions

Keywords

Covid19ICAMCytokinesTNF

Outcome Measures

Primary Outcomes (1)

  • Measure level of ICAM 1 and TNFα in RT PCR positive COVID 19 patients

    Quantitative detection for tumor necrosis factor alfa (TNF-α) \& intercellular adhesion molecule1 (ICAM-1) was performed using ELISA kits ( Bio reader by thermo fisher scientific Waltham, MA USA) according to the manufacture instructions.

    12 month

Study Arms (2)

confirmed COVID 19 ptients

All patients confirmed by RT-PCR, as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) who visited the emergency room and the outpatient clinic in the study period.

healthy subjects

normal healthy volunteers

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Mild pneumonia was confirmed by positive (qRT-PCR) tests, with no chest tomography features of viral pneumonia, moderate cases had pneumonia in CT chest while severe pneumonia was diagnosed as pneumonia plus 1 of these criteria: (1) respiratory rate ≥ 30 breath per minute with respiratory distress ;(2) saturation of oxygen ≤ 92 % at rest; (3) index of oxygenation ≤ 300 mmHg; (4) respiratory failure that require ventilation;(5) shock; and(6) admission to the ICU unit for other organ failure. CORAD score was calculated for all cases and was included in the radiology report. The degree of suspicion ranged from very low to very high (CO-RADS categories 1-5), while category 0 reflects negative infection and category 6 establishes RT-PCR-positive SARS-Cov-2 infection at time of examination 13.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University hospital

Banhā, Kalyobia, 13512, Egypt

Location

MeSH Terms

Conditions

COVID-19Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of chest diseases and tuberculosis

Study Record Dates

First Submitted

June 4, 2022

First Posted

June 7, 2022

Study Start

February 1, 2021

Primary Completion

December 30, 2021

Study Completion

February 12, 2022

Last Updated

June 14, 2022

Record last verified: 2022-06

Locations