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Clinical Trials/NCT05367882
NCT05367882CompletedNot Applicable

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

Assiut University1 site in 1 country96 target enrollmentStarted: February 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
96
Locations
1
Primary Endpoint
interleukin-6 levels

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

interleukin-6 levels

Time Frame: during one year

Measuring the levels of interleukin-6 in serum of patients.

anti-inflammatory markers

Time Frame: during one year

measuring the levels of some anti-inflammatory markers in serum of patients before and after treatment

interleukin-10 levels

Time Frame: during one year

measuring the levels of interleukin-10 in serum of patients before and after treatment

inflammatory markers

Time Frame: during one year

measuring the levels of some inflammatory markers in serum patients

interferon gamma inducible protein-10 levels

Time Frame: during one year

measuring the levels of IP-10 in serum of patients before and after treatment

Secondary Outcomes

  • survival(during one year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Reem Mohamed Mohamed Ahmed

Principle investigator

Assiut University

Study Sites (1)

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