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

Assiut University

Status: Completed

Conditions: Corona Virus Infection

Treatments: Diagnostic Test: ELISA

Study type: Observational

Funder types: Other

Identifiers

NCT05367882

interleukin6 levels

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

96 participants in 1 patient group

critically ill COVID-19 patients in ICU

Description:

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.

Treatment:

Diagnostic Test: ELISA