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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| critically ill COVID-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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELISA | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| interleukin-6 levels | Measuring the levels of interleukin-6 in serum of patients. | during one year |
| interleukin-10 levels | measuring the levels of interleukin-10 in serum of patients before and after treatment | during one year |
| inflammatory markers | measuring the levels of some inflammatory markers in serum patients | during one year |
| interferon gamma inducible protein-10 levels | measuring the levels of IP-10 in serum of patients before and after treatment | during one year |
| anti-inflammatory markers | measuring the levels of some anti-inflammatory markers in serum of patients before and after treatment | during one year |
| Measure | Description | Time Frame |
|---|---|---|
| survival | 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. | during one year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ventilatory support | Change in respiratory functions with no need for ventilatory support | during one year |
Inclusion Criteria:
Exclusion Criteria:
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samples will be collected over a duration of one year
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| Name | Affiliation | Role |
|---|---|---|
| mohammad gamal abalrahman, lecturer | Assiut university, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AssiutU | Asyut | 71515 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31995857 | Background | Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29. |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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serum samples of Corona virus disease-19 patients
| D007239 |
| Infections |