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

Corona Virus Infection Clinical Trial

Official title:

Effects of Sarilumab on Interleukin 6 Levels in Critically Ill COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05367882
• Other study ID #: interleukin6 levels
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: July 24, 2023

Study information

• Verified date: April 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 24, 2023
• Est. primary completion date: July 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections

Intervention

Diagnostic Test:
• ELISA
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

Locations

Country	Name	City	State
Egypt	AssiutU	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of ventilatory support	Change in respiratory functions with no need for ventilatory support	during one year
Primary	interleukin-6 levels	Measuring the levels of interleukin-6 in serum of patients.	during one year
Primary	interleukin-10 levels	measuring the levels of interleukin-10 in serum of patients before and after treatment	during one year
Primary	inflammatory markers	measuring the levels of some inflammatory markers in serum patients	during one year
Primary	interferon gamma inducible protein-10 levels	measuring the levels of IP-10 in serum of patients before and after treatment	during one year
Primary	anti-inflammatory markers	measuring the levels of some anti-inflammatory markers in serum of patients before and after treatment	during one year
Secondary	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