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Completed

NCT Number: NCT05035589

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

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.

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Key information

Conditions

COVID-19 Pneumonia ARDS

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mater Dei Hospital

Msida, MSD2090, Malta

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Tocilizumab

Drug

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

Primary outcomes

  1. Procalcitonin

    Time frame: throughout study completion, daily for maximum of 20 days

    effect of Tocilizumab on Procalcitonin levels

Secondary outcomes

  1. CRP

    Time frame: throughout study completion, daily for maximum of 20 days

    effect of Tocilizumab on CRP levels

  2. WCC

    Time frame: throughout study completion, daily for maximum of 20 days

    effect of Tocilizumab on WCC levels

  3. Neutrophils

    Time frame: throughout study completion, daily for maximum of 20 days

    effect of Tocilizumab on Neutrophils levels

  4. Lymphocytes

    Time frame: throughout study completion, daily for maximum of 20 days

    effect of Tocilizumab on Lymphocytes levels

  5. NLR

    Time frame: throughout study completion, daily for maximum of 20 days

    effect of Tocilizumab on Neutrophil to Lymphocyte ratio

  6. P/F ratio

    Time frame: throughout study completion, daily for maximum of 20 days

    effect of Tocilizumab on P/F ratio

Sponsors and collaborators

Lead sponsor

Sciberras, Stephen M.D.

Indiv

Collaborators

  • Mater Dei Hospital, Malta

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 5, 2021
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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