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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05035589

Enrollment

100

Registered

2021-09-05

Start date

2021-09-20

Completion date

2021-11-20

Last updated

2023-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, COVID-19 Pneumonia

Keywords

COVID-19 Pneumonia, Tocilizumab, Procalcitonin, C-Reactive Protein

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.

Interventions

DRUGTocilizumab

Tocilizumab administered at a dose of 8mg/kg up to a maximum of 800mg

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 100 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
Procalcitonin	throughout study completion, daily for maximum of 20 days	effect of Tocilizumab on Procalcitonin levels

Secondary

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

Countries

Malta

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026