TocilizumabNCT04893031
Effect of Tocilizumab on Intensive Care Patients With COVID-19 Pneumonia, a Retrospective Cohort Study
An observational study of Tocilizumab and COVID-19, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Although its safety and efficacy in the COVID-19 patient population are still unclear, tocilizumab is one of treatment. Tocilizumab is a U.S. Food and Drug Administration approved IL-6 receptor antagonist widely used to treat CRS secondary to the chimeric antigen receptor T cell. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tocilizumab, COVID-19, Critical Care
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- How many people
- 213 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 1 Apr 2021
- How long will I take part?
- 1 Month
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were diagnosed with COVID-19 and were admitted to intensive care unit
Who may be able to join
- All patients were admitted to intensive care unit, diagnosed with COVID-19 pneumonia
Who cannot join
- Patients who require mechanical ventilation in intensive care admission
- Cases who received tocilizumab after being intubated during follow-up even though they were not intubated at admission
- patients for whom tocilizumab is contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Although its safety and efficacy in the COVID-19 patient population are still unclear, tocilizumab is one of treatment. Tocilizumab is a U.S. Food and Drug Administration approved IL-6 receptor antagonist widely used to treat CRS secondary to the chimeric antigen receptor T cell. In this study the investigators will evaluate the efficacy of Tocilizumab, an IL-6 antagonist administered in the early period in intensive care patients with COVID-19 pneumonia followed by hypoxic and systemic inflammation is predominant, but who do not support mechanical ventilation.
Read the detailed description
With this study, the investigators will evaluate the efficacy of Tocilizumab, an IL-6 antagonist administered in the early period in intensive care patients with COVID-19 pneumonia followed by hypoxic and systemic inflammation is predominant, but who do not support mechanical ventilation.
With this study, those with signs of hypoxia and systemic inflammation followed by COVID-19 pneumonia (SpO2 <90% on room air together with the elevation of any two of the systemic inflammatory markers such as CRP, LDH and Ferritin) and / or acute bilateral infiltrates on chest radiograph and tocilizumab the patients who received treatment and those who received standard therapy will be compared.
In the study, cases followed up with COVID-19 pneumonia and respiratory failure between March 2020 and March 2021 will be retrospectively evaluated. Tocilizumab was applied as 400 mg - 800 mg iv (depending on weight). A second dose could be given 12-24 h later if the patient's condition had not improved. Primary end point was determined as intensive care mortality.
- Conditions
- Tocilizumab, COVID-19, Critical Care, Mortality
- Being tested
- Tocilizumab
- Keywords
- tocilizumab, COVID-19, Critical Care, Mortality
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
400mg or 800 mg IV tocilizumab treatment according to patient clinical severity
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab treatment group | Symptoms of hypoxia and systemic inflammation (SpO2 <90% on room air with accompanying elevation of any two of the systemic inflammatory markers such as CRP, LDH and Ferritin) and / or acute bilateral infiltrations on chest radiography or rapid progression of existing infiltrations, but who did not need mechanical ventilation at admission and were given tocilizumab treatment. Receives: Drug: Tocilizumab | |
| Standard treatment group | Patients who did not require mechanical ventilation in intensive care admission and did not receive tocilizumab treatment during any period of hospitalization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of intensive care mortality in the groups
all-cause mortality in the patient groups given and not given tocilizumab in the intensive care unit.
Measured: 28 Day
Secondary outcomes (1)
Rates of needed of mechanical ventilation in the groups
Intubation in tocilizumab or standard therapy group assessed by an event-time analysis.
Measured: 28 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 Mar 2020
- Primary completion1 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TocilizumabStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 213 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap Pehlivanlar Küçük, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893031
- Sponsor's protocol ID
- 2021/24
- Other IDs
- 2021-01-24T17_19_44
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared with researchers if contact with corresponded.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tocilizumab on Intensive Care Patients With COVID-19 Pneumonia, a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04893031
- Acronym / sponsor ID
- 2021/24
- Conditions
- Tocilizumab, COVID-19, Critical Care, Mortality
- Keywords
- tocilizumab, COVID-19, Critical Care, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 19 May 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.
Although its safety and efficacy in the COVID-19 patient population are still unclear, tocilizumab is one of treatment. Tocilizumab is a U.S. Food and Drug Administration approved IL-6 receptor antagonist widely used to treat CRS secondary to the chimeric antigen receptor T cell. In this study the investigators will evaluate the efficacy of Tocilizumab, an IL-6 antagonist administered in the early period in intensive care patients with COVID-19 pneumonia followed by hypoxic and systemic inflammation is predominant, but who do not support mechanical ventilation.
Detailed description
With this study, the investigators will evaluate the efficacy of Tocilizumab, an IL-6 antagonist administered in the early period in intensive care patients with COVID-19 pneumonia followed by hypoxic and systemic inflammation is predominant, but who do not support mechanical ventilation.
With this study, those with signs of hypoxia and systemic inflammation followed by COVID-19 pneumonia (SpO2 <90% on room air together with the elevation of any two of the systemic inflammatory markers such as CRP, LDH and Ferritin) and / or acute bilateral infiltrates on chest radiograph and tocilizumab the patients who received treatment and those who received standard therapy will be compared.
In the study, cases followed up with COVID-19 pneumonia and respiratory failure between March 2020 and March 2021 will be retrospectively evaluated. Tocilizumab was applied as 400 mg - 800 mg iv (depending on weight). A second dose could be given 12-24 h later if the patient's condition had not improved. Primary end point was determined as intensive care mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab treatment group | – | Drug: TocilizumabSymptoms of hypoxia and systemic inflammation (SpO2 <90% on room air with accompanying elevation of any two of the systemic inflammatory markers such as CRP, LDH and Ferritin) and / or acute bilateral infiltrations on chest radiography or rapid progression of existing infiltrations, but who did not need mechanical ventilation at admission and were given tocilizumab treatment. |
| Standard treatment group | – | –Patients who did not require mechanical ventilation in intensive care admission and did not receive tocilizumab treatment during any period of hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were diagnosed with COVID-19 and were admitted to intensive care unit
Key inclusion criteria (1 listed)
- All patients were admitted to intensive care unit, diagnosed with COVID-19 pneumonia
Key exclusion criteria (3 listed)
- Patients who require mechanical ventilation in intensive care admission
- Cases who received tocilizumab after being intubated during follow-up even though they were not intubated at admission
- patients for whom tocilizumab is contraindicated
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 |
|---|---|---|
| Tocilizumab400mg or 800 mg IV tocilizumab treatment according to patient clinical severity | Drug | Tocilizumab treatment group |
Primary outcome
Rates of intensive care mortality in the groups
Time frame: 28 Day
all-cause mortality in the patient groups given and not given tocilizumab in the intensive care unit.
1 secondary outcome
Rates of needed of mechanical ventilation in the groups
Time frame: 28 Day
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 20 May 2021.
- Individual participant dataSharing planned: Yes. Data can be shared with researchers if contact with corresponded.
Related trials for Tocilizumab
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
RecruitingPhase 2
A Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma
Not yet recruitingPhase 1/2
Tocilizumab Combined With First-Line Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer, Cancer-Associated Weight Loss
RecruitingPhase 4
Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)
Relapsed/Refractory Multiple Myeloma (RRMM)
Not yet recruitingPhase 2/3
Infarct Growth After Intravenous Tocilizumab in Adults With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy - ILLUMINATE
Acute Ischemic Stroke
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 Tocilizumab and COVID-19, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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 20 May 2021. 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 Turkey (Türkiye). 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?
Rates of intensive care mortality in the groups (time frame: 28 Day). 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 20 May 2021.