Corona Virus Infection
Conditions
Keywords
interleukin-6 receptor antagonists, Corona virus disease, sarilumab, interferon gamma inducible protein-10
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.
Interventions
DIAGNOSTIC_TESTELISA
collection of blood samples from critically ill COVID-19 patients, then serum samples are collected after centrifugation measuring IL-6, IL-10 and IP-10 by ELISA
Sponsors
Assiut University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| interleukin-10 levels | during one year | measuring the levels of interleukin-10 in serum of patients before and after treatment |
| interferon gamma inducible protein-10 levels | during one year | measuring the levels of IP-10 in serum of patients before and after treatment |
| anti-inflammatory markers | during one year | measuring the levels of some anti-inflammatory markers in serum of patients before and after treatment |
| interleukin-6 levels | during one year | Measuring the levels of interleukin-6 in serum of patients. |
| inflammatory markers | during one year | measuring the levels of some inflammatory markers in serum patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ventilatory support | during one year | Change in respiratory functions with no need for ventilatory support |
Countries
Egypt
Outcome results
None listed