Clinical trial NCT05279378: Correlation of Lung Ultrasonography With Chest CT Findings in Cancer Patients With COVID-19 Viral Pneumonia
Official title: Correlation of Lung Ultrasonography With Chest CT Findings in Cancer Patients With COVID-19 Viral Pneumonia, an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Patients
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 27
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Critical conditions need for ICU at the time of admission, presence of severe cardiorespiratory illness other than COVID-19 viral pneumonia, hepatic and renal diseases, coagulopathy, and patient refusal to share in our study will be considered as exclusion criteria.

Primary outcomes:
measure: comparing the CT versus LUS findings
timeFrame: 2 weeks
Secondary outcomes:
measure: correlation of the results with the level of IL-6
timeFrame: within 2 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt cancei institute
Study officials:
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