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

NCT ID: NCT05035589

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-20

Study Completion Date

2021-11-20

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.

Conditions

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COVID-19 Pneumonia ARDS

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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TCZ

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

Tocilizumab

Intervention Type DRUG

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

No interventions assigned to this group

Interventions

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Tocilizumab

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

16 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mater Dei Hospital, Malta

OTHER

Sponsor Role collaborator

Sciberras, Stephen M.D.

INDIV

Sponsor Role lead

Responsible Party

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Stephen Sciberras

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mater Dei Hospital

Msida, , Malta

Site Status

Countries

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Malta

Other Identifiers

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MDHITU-TCZ

Identifier Type: -

Identifier Source: org_study_id

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