Back to resultsHigh-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19
Primary Purpose
COVID-19 Virus Infection, Cytokine Storm, Corticosteroid
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Methylprednisolone
Tocilizumab
Sponsored by
About this trial
This is an interventional supportive care trial for COVID-19 Virus Infection
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- More than 14 days passed from the COVID-19 diagnosis
- Clinical and laboratory signs of secondary bacterial infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pulse methylprednisolone
Tocilizumab
Arm Description
250 mg methylprednisolone for 3 days
Tocilizumab 400-800 mg for one time
Outcomes
Primary Outcome Measures
Clinical condition
Arterial oxygen partial pressure of the patient will be observed.
Blood analysis
Acute phase reactants (C-reactive protein, procalcitonin, ferritin, fibrinogen), will be investigated.
Secondary Outcome Measures
Hospital stay
Hospital stay period of the patients will be observed.
Mortality
Mortality of the patients will be observed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05133635
Brief Title
High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19
Official Title
Comparison of the Treatment Efficacy of High-Dose Corticosteroid and Tocilizumab During Clinical Worsening in Patients With COVID-19 Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
A recent study suggested a new corticosteroid regime for intensive care unit patients.
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Virus Infection, Cytokine Storm, Corticosteroid, Tocilizumab
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulse methylprednisolone
Arm Type
Active Comparator
Arm Description
250 mg methylprednisolone for 3 days
Arm Title
Tocilizumab
Arm Type
Active Comparator
Arm Description
Tocilizumab 400-800 mg for one time
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Corticosteroid
Intervention Description
Patients with the clinical and laboratory diagnosis of cytokine storm will receive methylprednisolone 250 mg for 3 days.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
Patients with the clinical and laboratory diagnosis of cytokine storm will receive tocilizumab 400-800 mg for one time.
Primary Outcome Measure Information:
Title
Clinical condition
Description
Arterial oxygen partial pressure of the patient will be observed.
Time Frame
Next 7 days of the intervention.
Title
Blood analysis
Description
Acute phase reactants (C-reactive protein, procalcitonin, ferritin, fibrinogen), will be investigated.
Time Frame
Next 7 days of the intervention.
Secondary Outcome Measure Information:
Title
Hospital stay
Description
Hospital stay period of the patients will be observed.
Time Frame
Until the hospital discharge.
Title
Mortality
Description
Mortality of the patients will be observed.
Time Frame
Not relevant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
More than 14 days passed from the COVID-19 diagnosis
Clinical and laboratory signs of secondary bacterial infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruslan Abdullayev
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19
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