Effects of Sarilumab on Interleukin 6 Levels in Critically Ill COVID-19 Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- interleukin-6 levels
Study Overview
Brief Summary
- Investigate the possible effects of interleukin-6 receptor antagonists such as tocilizumab and sarilumab on the levels of IL-6, inflammtory and anti-inflammtory markers and cytokines before and after treatment in critically ill corona virus disease-19 patients.
- Correlate between IL-6 levels with other inflammatory markers as ferritin and C-reactive protein.
- investigate the possible changes on the levels of other inflammatory, anti-inflammatory markers and cytokines such as IL-10 and IP-10, before and after treatment.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •must be critically ill coronavirus disease-19
Exclusion Criteria
- •patients receiving corticosteroids
- •pregnancy
- •active TB
- •bacterial infection
- •fungal infection
- •co-infection with other hepatitis viruses.
Outcomes
Primary Outcomes
interleukin-6 levels
Time Frame: during one year
Measuring the levels of interleukin-6 in serum of patients.
anti-inflammatory markers
Time Frame: during one year
measuring the levels of some anti-inflammatory markers in serum of patients before and after treatment
interleukin-10 levels
Time Frame: during one year
measuring the levels of interleukin-10 in serum of patients before and after treatment
inflammatory markers
Time Frame: during one year
measuring the levels of some inflammatory markers in serum patients
interferon gamma inducible protein-10 levels
Time Frame: during one year
measuring the levels of IP-10 in serum of patients before and after treatment
Secondary Outcomes
- survival(during one year)
Investigators
Reem Mohamed Mohamed Ahmed
Principle investigator
Assiut University
