The Effect of Tocilizumab on Procalcitonin and Other Bioc... | NCT05035589

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

NCT05035589

Sponsor

Sciberras, Stephen M.D.

Status

Completed

Last Update Posted

Apr 11, 2023Actual

Enrollment

100Actual

Phase

Not provided

Conditions

COVID-19 Pneumonia
ARDS

Interventions

Tocilizumab

Countries

Malta

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2021Actual

Primary Completion Date

Oct 20, 2021Actual

Completion Date

Nov 20, 2021Actual

First Submitted Date

Aug 26, 2021

First Submission Date that Met QC Criteria

Sep 2, 2021

First Posted Date

Sep 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2023

Last Update Posted Date

Apr 11, 2023Actual

Name	Class
Mater Dei Hospital, Malta	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tocilizumab	Drug	Tocilizumab administered at a dose of 8mg/kg up to a maximum of 800mg	TCZ

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Procalcitonin	effect of Tocilizumab on Procalcitonin levels	throughout study completion, daily for maximum of 20 days

Secondary Outcomes

Measure	Description	Time Frame
CRP	effect of Tocilizumab on CRP levels	throughout study completion, daily for maximum of 20 days
WCC	effect of Tocilizumab on WCC levels

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed COVID-19 diagnosis
Admitted to ITU
Tocilizumab treatment

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mater Dei Hospital		Msida		MSD2090	Malta

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C502936	tocilizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided