Clinical trial NCT05367882: Effect of Interleukin 6 Receptor Antagonists in SARS-CoV-2 Patients
Official title: Effects of Sarilumab on Interleukin 6 Levels in Critically Ill COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corona Virus Infection
Keywords: interleukin-6 receptor antagonists
Corona virus disease
sarilumab
interferon gamma inducible protein-10
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: samples will be collected over a duration of one year

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.

Eligibility 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.

Primary outcomes:
measure: interleukin-6 levels
timeFrame: during one year
measure: interleukin-10 levels
timeFrame: during one year
measure: inflammatory markers
timeFrame: during one year
measure: interferon gamma inducible protein-10 levels
timeFrame: during one year
measure: anti-inflammatory markers
timeFrame: during one year
Secondary outcomes:
measure: survival
timeFrame: during one year
Other outcomes:
measure: Incidence of ventilatory support
timeFrame: during one year
Locations:
city: Assiut
country: Egypt
facility: AssiutU
Study officials:
affiliation: Assiut university, Egypt
name: mohammad gamal abalrahman, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.