COVID-19 PneumoniaNCT05035589
The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia
An observational study of COVID-19 Pneumonia and ARDS, run by Sciberras, Stephen M.D. at 1 site in Malta.
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. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- COVID-19 Pneumonia, ARDS
- What is being tested?
- Tocilizumab
- How many people
- 100 participants
- Where
- 1 siteMalta
- Study dates
- 20 Sep 2021to 20 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: COVID-19 patients treated with tocilizumab single dose therapy in ICU
Who may be able to join
- Confirmed COVID-19 diagnosis
- Admitted to ITU
- Tocilizumab treatment
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- COVID-19 Pneumonia, ARDS
- Being tested
- Tocilizumab
- Keywords
- COVID-19 Pneumonia, Tocilizumab, Procalcitonin, C-Reactive Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Tocilizumab administered at a dose of 8mg/kg up to a maximum of 800mg
| Study group | Role | What they receive |
|---|---|---|
| TCZ | The first 50 patients admitted to the ITU at Mater Dei Hospital with COVID-19 Pneumonia, to whom tocilizumab was administered Receives: Drug: Tocilizumab | |
| Control | 50 patients admitted to ITU at Mater Dei Hospital with COVID-19 Pneumonia, who did not receive Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procalcitonin
effect of Tocilizumab on Procalcitonin levels
Measured: throughout study completion, daily for maximum of 20 days
Secondary outcomes (6)
CRP
effect of Tocilizumab on CRP levels
Measured: throughout study completion, daily for maximum of 20 days
WCC
effect of Tocilizumab on WCC levels
Measured: throughout study completion, daily for maximum of 20 days
Neutrophils
effect of Tocilizumab on Neutrophils levels
Measured: throughout study completion, daily for maximum of 20 days
Lymphocytes
effect of Tocilizumab on Lymphocytes levels
Measured: throughout study completion, daily for maximum of 20 days
NLR
effect of Tocilizumab on Neutrophil to Lymphocyte ratio
Measured: throughout study completion, daily for maximum of 20 days
P/F ratio
effect of Tocilizumab on P/F ratio
Measured: throughout study completion, daily for maximum of 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start20 Sep 2021
- Primary completion20 Oct 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciberras, Stephen M.D.
- Collaborators
- Mater Dei Hospital, Malta
- Responsible party
- Principal investigator, Stephen Sciberras, Sciberras, Stephen M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035589
- Sponsor's protocol ID
- MDHITU-TCZ
- Status last verified
- Apr 2023
- First submitted
- 26 Aug 2021
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tocilizumab on Procalcitonin and Other Biochemical and Clinical Markers in the Setting of COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT05035589
- Acronym / sponsor ID
- MDHITU-TCZ
- Conditions
- COVID-19 Pneumonia, ARDS
- Keywords
- COVID-19 Pneumonia, Tocilizumab, Procalcitonin, C-Reactive Protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sciberras, Stephen M.D.
- Collaborators
- Mater Dei Hospital, Malta
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCZ | – | Drug: TocilizumabThe first 50 patients admitted to the ITU at Mater Dei Hospital with COVID-19 Pneumonia, to whom tocilizumab was administered |
| Control | – | –50 patients admitted to ITU at Mater Dei Hospital with COVID-19 Pneumonia, who did not receive Tocilizumab |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- COVID-19 patients treated with tocilizumab single dose therapy in ICU
Key inclusion criteria (3 listed)
- Confirmed COVID-19 diagnosis
- Admitted to ITU
- Tocilizumab treatment
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabTocilizumab administered at a dose of 8mg/kg up to a maximum of 800mg | Drug | TCZ |
Primary outcome
Procalcitonin
Time frame: throughout study completion, daily for maximum of 20 days
effect of Tocilizumab on Procalcitonin levels
6 secondary outcomes
CRP
Time frame: throughout study completion, daily for maximum of 20 days
WCC
Time frame: throughout study completion, daily for maximum of 20 days
Neutrophils
Time frame: throughout study completion, daily for maximum of 20 days
Lymphocytes
Time frame: throughout study completion, daily for maximum of 20 days
NLR
Time frame: throughout study completion, daily for maximum of 20 days
P/F ratio
Time frame: throughout study completion, daily for maximum of 20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19 Pneumonia
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
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RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruitingPhase 2
Prevention of COVID-19 Infection to Severe Pneumonia or ARDS
Covid19 Pneumonia
RecruitingPhase 3
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
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RecruitingPhase 3
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
COVID-19 Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and ARDS, run by Sciberras, Stephen M.D. at 1 site in Malta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malta. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procalcitonin (time frame: throughout study completion, daily for maximum of 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.