NCT05279378

Brief Summary

Thoracic imaging, either with chest X-ray (CXR) or computed tomography (CT), is an essential part of the diagnosis of coronavirus disease-19 (COVID-19) in patients admitted to hospital with fever or respiratory symptoms. Inspite of the results of PCR tests are the gold standard, the sensitivity of CT for diagnosing COVID-19 is 97%. The specific epidemic contingency makes CT an accurate tool to stratify patients based on imaging patterns, predicting poor outcomes and the need for ventilation. Lung ultrasound (LUS) is widely used in emergency departments because it is broadly available, low-cost, and has a high accuracy for diagnosing pulmonary diseases. Despite the diagnostic power of LUS and its influence on decision-making and therapeutic management, there are still significant barriers to the widespread use of this tool. The advantages of LUS are more obvious in older patients with multimorbidity and restricted mobility, for whom high-quality CXR and CT scans are difficult to obtain. In the hands of experienced clinicians, LUS diagnostic accuracy for bacterial pneumonia is similar to chest CT. However, a correlation between LUS and CT findings in patient urgently hospitalized for severe COVID-19 pneumonia remains to be determined. COVID-19 leads to an aggressive inflammatory response that is actually the reaction of the immune system. Some patients exhibit pneumonia in both lungs, multi-organ failure, and even death. Individuals who have severe health conditions, like cancer, cardiovascular diseases, diabetes, and pulmonary diseases, are at higher risk of COVID-19 infection. Also, this dysregulated immune response resulting in excessive production of inflammatory cytokines and chemokines (as IL-1ra, IL-6, IP-10, G-CSF, MCP-1, MIP-1α and TNF) causes the development of cytokine release syndrome (CRS) which is considered as pathologic underpinning for disease progression and lead to severe collateral tissue damage. IL-6 may serve as a predictive biomarker for disease severity as its elevated levels were reported in several studies of COVID-19 infection. Also IL-6 levels were correlated with mortality in COVID-19 patients. IL-6 blockade is a promising strategy for COVID-induced CRS. In particular, clinical epidemiological studies are needed to determine if IL-6 and/or other inflammatory cytokine levels predict subsequent development and persistence of long COVID 19 viral pneumonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Typical duration 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

First Submitted

Initial submission to the registry

March 11, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2025

Completed
Last Updated

February 18, 2026

Status Verified

March 1, 2022

Enrollment Period

3.3 years

First QC Date

March 11, 2022

Last Update Submit

February 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • comparing the CT versus LUS findings

    comparing the CT versus LUS findings in cancer patients with moderate and severe COVID-19 viral pneumonia who will be admitted to our hospital and to correlate these findings with clinical features

    2 weeks

Secondary Outcomes (1)

  • correlation of the results with the level of IL-6

    within 2 weeks

Interventions

chest CT will be done before admission and LUS within first 24 h from admission into the quarantine sector. In addition to 2 weeks after admission. CT images will be reviewed by chest radiologist expert, who will calculate a CT severity score based on extension and distribution of GGOs and consolidations. All CT scans will be performed in supine position at end inspiration without intravenous administration of contrast media. Within 24 h from admission and CT scanning, bedside LUS will be performed by clinician who will be blind to chest CT findings. Examinations will be performed with the patient in the sitting position, systematically scanning the front and the back side of each hemithorax. Blood sample will be collected into 4 mL Vacuette containing EDTA. Samples will be stored on ice, processed within 30 min and plasma will be isolated by centrifugation at 2000g for 20 min at 4 °C. Plasma will be immediately frozen at - 80 °C in several aliquots.

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients admitted to South Egypt Cancer Institute (SECI), Asyut University, Egypt with COVID-19 viral pneumonia in the period from March 2022 to December 2023, with ages ranging from 18 to 60 years old, of male or female gender, and CT Chest findings of CORAD 4, 5 and 6 with moderate and severe symptoms.

You may qualify if:

  • The study population will include cancer patients admitted to South Egypt Cancer Institute (SECI), Asyut University, Egypt with COVID-19 viral pneumonia in the period from March 2022 to December 2023, with ages ranging from 18 to 60 years old, of male or female gender, and CT Chest findings of CORAD 4, 5 and 6 with moderate and severe symptoms.
  • All cancer patients are diagnosed COVID-19 by PCR from a nasopharyngeal swab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt cancei institute

Asyut, Egypt

Location

Related Publications (24)

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Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 15, 2022

Study Start

March 30, 2022

Primary Completion

June 30, 2025

Study Completion

November 28, 2025

Last Updated

February 18, 2026

Record last verified: 2022-03

Locations