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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05035589
Other study ID # MDHITU-TCZ
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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