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NCT05367882 | Completed | Corona Virus Infection


Effect of Interleukin 6 Receptor Antagonists in SARS-CoV-2 Patients
Sponsor:

Assiut University

Information provided by (Responsible Party):

Reem Mohamed Mohamed Ahmed

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.

Condition or disease

Corona Virus Infection

Intervention/treatment

ELISA

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 Type : Observational
Estimated Enrollment : 96 participants
Official Title: Effects of Sarilumab on Interleukin 6 Levels in Critically Ill COVID-19 Patients
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : July 20, 2023
Estimated Study Completion Date : July 24, 2023

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.

Effect of Interleukin 6 Receptor Antagonists in SARS-CoV-2 Patients

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Effect of Interleukin 6 Receptor Antagonists in SARS-CoV-2 Patients

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Locations


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Egypt,

AssiutU

Assiut, Egypt, 71515

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