COVID-19 Virus InfectionPhase 4NCT05133635
High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19
A Phase 4 study testing Methylprednisolone and Tocilizumab in people with COVID-19 Virus Infection and Cytokine Storm, run by Marmara University.
Trial summary
COVID-19 pandemic has spread all over the world, and hospitalization of the patients with COVİD-19 Pneumonia has become a great burden to the Intensive Care Units. Unfortunately there is still no curative method for the disease yet. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19 Virus Infection, Cytokine Storm, Corticosteroid
- What is being tested?
- Methylprednisolone and Tocilizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 1 Apr 2021
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with COVID-19 Pneumonia treated in the Intensive Care Unit
- Clinical deterioration during intensive care follow-up
- First 14 days from the COVID-19 diagnosis
Who cannot join
- More than 14 days passed from the COVID-19 diagnosis
- Clinical and laboratory signs of secondary bacterial infection
About this study
Official title: Comparison of the Treatment Efficacy of High-Dose Corticosteroid and Tocilizumab During Clinical Worsening in Patients With COVID-19 Pneumonia
COVID-19 pandemic has spread all over the world, and hospitalization of the patients with COVİD-19 Pneumonia has become a great burden to the Intensive Care Units. Unfortunately there is still no curative method for the disease yet. Intensive Care Units provide general care for the patients; including oxygen therapy, maintenance of the organ systems (e.g., cardiovascular, renal), nutrition, antibiotic therapy for secondary infections, and etc.
One of the major problems in COVID-19 is macrophage activation syndrome, also known as cytokine storm. It stems from exaggerated inflammatory response, which causes increased cytokine release and results in clinical deterioration of the patients. Many drugs have been used to prevent this exaggerated inflammation, like corticosteroids, interleukin (IL) receptor blockers, plasma exchange, etc.
In this study our aim is to investigate the effectiveness of high dose corticosteroid (methylprednisolone 250 mg for 3 days) and an IL-6 receptor antagonist (tocilizumab) in the treatment of the cytokine storm of the COVID-19 patients.
- Conditions
- COVID-19 Virus Infection, Cytokine Storm, Corticosteroid, Tocilizumab
- Being tested
- Methylprednisolone, Tocilizumab
- Medical subject headings
- COVID-19, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Corticosteroid
Patients with the clinical and laboratory diagnosis of cytokine storm will receive methylprednisolone 250 mg for 3 days.
TocilizumabDrug
Patients with the clinical and laboratory diagnosis of cytokine storm will receive tocilizumab 400-800 mg for one time.
| Study group | Role | What they receive |
|---|---|---|
| Pulse methylprednisolone | Active comparator | 250 mg methylprednisolone for 3 days Receives: Drug: Methylprednisolone |
| Tocilizumab | Active comparator | Tocilizumab 400-800 mg for one time Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical condition
Arterial oxygen partial pressure of the patient will be observed.
Measured: Next 7 days of the intervention.
Blood analysis
Acute phase reactants (C-reactive protein, procalcitonin, ferritin, fibrinogen), will be investigated.
Measured: Next 7 days of the intervention.
Secondary outcomes (2)
Hospital stay
Hospital stay period of the patients will be observed.
Measured: Until the hospital discharge.
Mortality
Mortality of the patients will be observed.
Measured: Not relevant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Feb 2021
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Why it stopped: A recent study suggested a new corticosteroid regime for intensive care unit patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Virus InfectionStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruslan Abdullayev, Marmara University
- Investigators
- Ruslan Abdullayev, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133635
- Sponsor's protocol ID
- Steroid/Toci COVID-19
- Status last verified
- Nov 2021
- First submitted
- 11 Jan 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Treatment Efficacy of High-Dose Corticosteroid and Tocilizumab During Clinical Worsening in Patients With COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT05133635
- Acronym / sponsor ID
- Steroid/Toci COVID-19
- Conditions
- COVID-19 Virus Infection, Cytokine Storm, Corticosteroid, Tocilizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A recent study suggested a new corticosteroid regime for intensive care unit patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 24 Nov 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.
COVID-19 pandemic has spread all over the world, and hospitalization of the patients with COVİD-19 Pneumonia has become a great burden to the Intensive Care Units. Unfortunately there is still no curative method for the disease yet. Intensive Care Units provide general care for the patients; including oxygen therapy, maintenance of the organ systems (e.g., cardiovascular, renal), nutrition, antibiotic therapy for secondary infections, and etc.
One of the major problems in COVID-19 is macrophage activation syndrome, also known as cytokine storm. It stems from exaggerated inflammatory response, which causes increased cytokine release and results in clinical deterioration of the patients. Many drugs have been used to prevent this exaggerated inflammation, like corticosteroids, interleukin (IL) receptor blockers, plasma exchange, etc.
In this study our aim is to investigate the effectiveness of high dose corticosteroid (methylprednisolone 250 mg for 3 days) and an IL-6 receptor antagonist (tocilizumab) in the treatment of the cytokine storm of the COVID-19 patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulse methylprednisolone | Active comparator | Drug: Methylprednisolone250 mg methylprednisolone for 3 days |
| Tocilizumab | Active comparator | Drug: TocilizumabTocilizumab 400-800 mg for one time |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with COVID-19 Pneumonia treated in the Intensive Care Unit
- Clinical deterioration during intensive care follow-up
- First 14 days from the COVID-19 diagnosis
Key exclusion criteria (2 listed)
- More than 14 days passed from the COVID-19 diagnosis
- Clinical and laboratory signs of secondary bacterial infection
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 |
|---|---|---|
| MethylprednisoloneAlso: CorticosteroidPatients with the clinical and laboratory diagnosis of cytokine storm will receive methylprednisolone 250 mg for 3 days. | Drug | Pulse methylprednisolone |
| TocilizumabPatients with the clinical and laboratory diagnosis of cytokine storm will receive tocilizumab 400-800 mg for one time. | Drug | Tocilizumab |
Primary outcome
Clinical condition
Time frame: Next 7 days of the intervention.
Arterial oxygen partial pressure of the patient will be observed.
Blood analysis
Time frame: Next 7 days of the intervention.
Acute phase reactants (C-reactive protein, procalcitonin, ferritin, fibrinogen), will be investigated.
2 secondary outcomes
Hospital stay
Time frame: Until the hospital discharge.
Mortality
Time frame: Not relevant
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Ruslan Abdullayev principal investigator
Marmara University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone and Tocilizumab in people with COVID-19 Virus Infection and Cytokine Storm, run by Marmara University.
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 2 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: withdrawn, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical condition (time frame: Next 7 days of the intervention.). The study lists 2 primary outcomes in all. 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 24 Nov 2021.