The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia

Study Overview
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Brief Summary
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This study aims to establish whether tocilizumab has any significant effect on procalcitonin levels on patients diagnosed with COVID-19 pneumonia requiring intensive care admission. The effects on other biochemical and clinical markers are also considered.

Detailed Description
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A retrospective study, involving the first fifty patients treated with tocilizumab for acute deterioration in COVID-19 pneumonia in the Intensive Care Unit (ICU) at Mater Dei Hospital in Malta. The following parameters will be collected from medical records: procalcitonin levels, daily for twenty days or until discharge or death. namely white cell count (WCC), neutrophils, lymphocytes, C-reactive protein (CRP) PaO2/FiO2 ratio (P/F ratio). This group will be compared to a control group was chosen from patients admitted to the ICU who were not eligible for tocilizumab treatment, matched to the study group for age, gender, mode of ventilation required and length of stay in ICU.

Official Title
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The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia

Conditions
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ARDS, COVID-19 Pneumonia

Intervention / Treatment
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* Drug: Tocilizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed COVID-19 diagnosis Admitted to ITU Tocilizumab treatment Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TCZ<br>The first 50 patients admitted to the ITU at Mater Dei Hospital with COVID-19 Pneumonia, to whom tocilizumab was administered | Drug: Tocilizumab<br>* Tocilizumab administered at a dose of 8mg/kg up to a maximum of 800mg<br>|
| Control<br>50 patients admitted to ITU at Mater Dei Hospital with COVID-19 Pneumonia, who did not receive Tocilizumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procalcitonin | effect of Tocilizumab on Procalcitonin levels | throughout study completion, daily for maximum of 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP | effect of Tocilizumab on CRP levels | throughout study completion, daily for maximum of 20 days | 
| WCC | effect of Tocilizumab on WCC levels | throughout study completion, daily for maximum of 20 days | 
| Neutrophils | effect of Tocilizumab on Neutrophils levels | throughout study completion, daily for maximum of 20 days | 
| Lymphocytes | effect of Tocilizumab on Lymphocytes levels | throughout study completion, daily for maximum of 20 days | 
| NLR | effect of Tocilizumab on Neutrophil to Lymphocyte ratio | throughout study completion, daily for maximum of 20 days | 
| P/F ratio | effect of Tocilizumab on P/F ratio | throughout study completion, daily for maximum of 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 Pneumonia, Tocilizumab, Procalcitonin, C-Reactive Protein