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

ARDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05035589
• Other study ID #: MDHITU-TCZ
• Status: Completed
• Start date: September 20, 2021
• Est. completion date: November 20, 2021

Study information

• Verified date: April 2023
• Source: Sciberras, Stephen M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

Inclusion Criteria:

• Confirmed COVID-19 diagnosis

• Admitted to ITU

• Tocilizumab treatment

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• ARDS
• COVID-19
• COVID-19 Pneumonia
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
Malta	Mater Dei Hospital	Imsida

Sponsors (2)

Lead Sponsor	Collaborator
Sciberras, Stephen M.D.	Mater Dei Hospital, Malta

Country where clinical trial is conducted

Malta, 

Outcome

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