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

April 10, 2023 updated by: Stephen Sciberras, Sciberras, Stephen M.D.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malta
      • Imsida, Malta, MSD2090
        • Mater Dei Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

COVID-19 patients treated with tocilizumab single dose therapy in ICU

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sciberras, Stephen M.D.

Collaborators

Mater Dei Hospital, Malta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Actual)

October 20, 2021

Study Completion (Actual)

November 20, 2021

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDHITU-TCZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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