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CompletedNCT05035589Updated Apr 11, 2023

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

An observational study in COVID-19 Pneumonia and ARDS, sponsored by Sciberras, Stephen M.D.. Completed at 1 site in Malta. Open to participants aged 16 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-04-11.

Sponsored by Sciberras, Stephen M.D. · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
100
Ages
16 Years to 100 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • COVID-19 Pneumonia
  • ARDS

Keywords

  • COVID-19 Pneumonia
  • Tocilizumab
  • Procalcitonin
  • C-Reactive Protein
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 100 is below the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Sciberras, Stephen M.D. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • TCZ

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

    Drug: Tocilizumab

  • Control

    50 patients admitted to ITU at Mater Dei Hospital with COVID-19 Pneumonia, who did not receive Tocilizumab

Interventions

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

06

What researchers measure

Primary outcomes

  1. Procalcitonin

    effect of Tocilizumab on Procalcitonin levels

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

Secondary outcomes

  1. CRP

    effect of Tocilizumab on CRP levels

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

  2. WCC

    effect of Tocilizumab on WCC levels

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

  3. Neutrophils

    effect of Tocilizumab on Neutrophils levels

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

  4. Lymphocytes

    effect of Tocilizumab on Lymphocytes levels

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

  5. NLR

    effect of Tocilizumab on Neutrophil to Lymphocyte ratio

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

  6. P/F ratio

    effect of Tocilizumab on P/F ratio

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

07

Study locations

1 site
  • Mater Dei Hospital
    Imsida, MSD2090, Malta
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05035589
Lead sponsor
Sciberras, Stephen M.D.
Collaborators
Mater Dei Hospital, Malta
Responsible party
Stephen Sciberras (Investigator, Sciberras, Stephen M.D.) — Principal investigator
First posted
Sep 5, 2021
Start date
Sep 20, 2021
Primary completion
Oct 20, 2021
Completion
Nov 20, 2021
Last update
Apr 11, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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