Effect of Interleukin 6 Receptor Antagonists in SARS-CoV-2 Patients
- Conditions
- Corona Virus Infection
- Interventions
- Diagnostic Test: ELISA
- Registration Number
- NCT05367882
- Lead Sponsor
- Assiut University
- Brief Summary
1. 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.
2. Correlate between IL-6 levels with other inflammatory markers as ferritin and C-reactive protein.
3. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- must be critically ill coronavirus disease-19
- patients receiving corticosteroids
- pregnancy
- active TB
- bacterial infection
- fungal infection
- co-infection with other hepatitis viruses.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description critically ill COVID-19 patients in ICU ELISA 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.
- Primary Outcome Measures
Name Time Method interleukin-10 levels during one year measuring the levels of interleukin-10 in serum of patients before and after treatment
inflammatory markers during one year measuring the levels of some inflammatory markers in serum patients
interferon gamma inducible protein-10 levels during one year measuring the levels of IP-10 in serum of patients before and after treatment
interleukin-6 levels during one year Measuring the levels of interleukin-6 in serum of patients.
anti-inflammatory markers during one year measuring the levels of some anti-inflammatory markers in serum of patients before and after treatment
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
AssiutU
🇪🇬Assiut, Egypt