Effect of Interleukin 6 Receptor Antagonists in Corona Virus Disease 19 Patients Known by WHO
Study Details
Study Description
Brief Summary
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Investigate the possible effects of interleukin-6 receptor antagonists such as tocilizumab and sarilumab on the levels of IL-6 before and after treatment in critically ill corona virus disease-19 patients.
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Correlate between IL-6 levels with other inflammatory markers as ferritin and C-reactive protein.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
An outbreak of a mutated respiratory virus that belongs to the Coronavirus family was reported in mid-December 2019, in Wuhan, China. The virus was named as severe acute respiratory syndrome coronavirus (SARS-CoV-2) and the disease was named as coronavirus disease-19 (COVID-19) by the WHO. The infection spread pandemically and by the end of October 2021,the number of confirmed cases of COVID-19 reached 244,897,472, including 4,970,435 deaths, reported by WHO. Viral genome was sequenced and published by public health information on 10th of January. COVID-19 uses the same cell entry receptor {Angiotensin converting enzyme II} (ACE2) as SARS-CoV . Recent studies have shown that IL-6 level increased in severe cases of COVID-19. IL-6 is one of the major pro-inflammatory factors that contribute to the formation of cytokine storm.Therefore, the IL-6 monoclonal antibody (mAb) directed COVID-19 therapy has been used in clinical trial in China. The main conclusion they reached was that the treatment with the IL-6 receptor antagonists ( tocilizumab (TCZ), sarilumab, sirukumab, olamkicept and levilimab) improved outcomes, including survival. TCZ is a humanized antibody that blocks both soluble and membrane-bound forms of IL-6 receptor. Sarilumab is a fully human antibody against the IL-6 receptor that binds to both soluble and membrane-bound IL-6 receptors and has the approval of the food and drug administration (FDA) for rheumatoid arthritis (RA) treatment. Additionally, these drugs have been considered for off-label use in the treatment of COVID-19.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| critically ill COVUD-19 patients in ICU critically ill COVID-19 patients who are recommended to receive IL-6R antagonist as tocilizumab at the dosage of 8 mg/kg with a second dose 12 hours after the first dosage, or sarilumab at the dosage of 200 mg subcutaneously or 200 to 800 mg intravenously. |
Diagnostic Test: ELISA
collection of blood samples from critically ill COVID-19 patients, then serum samples are collected after centrifugation measuring IL-6 by ELISA
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Outcome Measures
Primary Outcome Measures
- interleukin-6 levels [during one year]
Measuring the levels of interrleukin-6 in serum of patients.
Secondary Outcome Measures
- survival [during one year]
Calculation of the possible correlation between the variation in interleukin-6 levels and different clinical and laboratory parameters including patient's survival and hospital stay.
Other Outcome Measures
- Incidence of ventilatory support [during one year]
Change in respiratory functions with no need for ventilatory support
Eligibility Criteria
Criteria
Inclusion Criteria:
- must be critically ill coronavirus disease-19
Exclusion Criteria:
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patients receiving corticosteroids
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pregnancy
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active TB
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bacterial infection
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fungal infection
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co-infection with other hepatitis viruses.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AssiutU | Assiut | Egypt | 71111 |
Sponsors and Collaborators
- Assiut University
Investigators
- Principal Investigator: mohammad gamal abalrahman, lecturer, Assiut University
Study Documents (Full-Text)
None provided.More Information
Publications
- interleukin6 levels