NCT05035589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2021

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

August 26, 2021

Last Update Submit

April 10, 2023

Conditions

COVID-19 PneumoniaARDS

Keywords

COVID-19 PneumoniaTocilizumabProcalcitoninC-Reactive Protein

Outcome Measures

Primary Outcomes (1)

  • Procalcitonin

    effect of Tocilizumab on Procalcitonin levels

    throughout study completion, daily for maximum of 20 days

Secondary Outcomes (6)

  • CRP

    throughout study completion, daily for maximum of 20 days

  • WCC

    throughout study completion, daily for maximum of 20 days

  • Neutrophils

    throughout study completion, daily for maximum of 20 days

  • Lymphocytes

    throughout study completion, daily for maximum of 20 days

  • NLR

    throughout study completion, daily for maximum of 20 days

  • +1 more secondary outcomes

Study Arms (2)

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

TocilizumabDRUG

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

TCZ

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mater Dei Hospital

Msida, MSD2090, Malta

Location

MeSH Terms

Interventions

tocilizumab

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

August 26, 2021

First Posted

September 5, 2021

Study Start

September 20, 2021

Primary Completion

October 20, 2021

Study Completion

November 20, 2021

Last Updated

April 11, 2023

Record last verified: 2023-04

Locations

MA(1)