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

Completed

• Conditions: COVID-19 Pneumonia; ARDS
• Interventions: Drug: Tocilizumab

• Registration Number: NCT05035589
• Lead Sponsor: Sciberras, Stephen M.D.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-05
• Study Start: 2021-09-20
• Primary Completion: 2021-10-20
• Study Completion: 2021-11-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Confirmed COVID-19 diagnosis
• Admitted to ITU
• Tocilizumab treatment

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TCZ	Tocilizumab	The first 50 patients admitted to the ITU at Mater Dei Hospital with COVID-19 Pneumonia, to whom tocilizumab was administered

Primary Outcome Measures

Name	Time	Method
Procalcitonin	throughout study completion, daily for maximum of 20 days	effect of Tocilizumab on Procalcitonin levels

Secondary Outcome Measures

Name	Time	Method
P/F ratio	throughout study completion, daily for maximum of 20 days	effect of Tocilizumab on P/F ratio
CRP	throughout study completion, daily for maximum of 20 days	effect of Tocilizumab on CRP levels
WCC	throughout study completion, daily for maximum of 20 days	effect of Tocilizumab on WCC levels
NLR	throughout study completion, daily for maximum of 20 days	effect of Tocilizumab on Neutrophil to Lymphocyte ratio
Neutrophils	throughout study completion, daily for maximum of 20 days	effect of Tocilizumab on Neutrophils levels
Lymphocytes	throughout study completion, daily for maximum of 20 days	effect of Tocilizumab on Lymphocytes levels

Trial Locations

Locations (1)

Mater Dei Hospital; 🇲🇹 Imsida, Malta