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OpenTrials
Completed

NCT Number: NCT05367882

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AssiutU

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ELISA

Diagnostic Test

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

Primary outcomes

  1. interleukin-6 levels

    Time frame: during one year

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

  2. interleukin-10 levels

    Time frame: during one year

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

  3. inflammatory markers

    Time frame: during one year

    measuring the levels of some inflammatory markers in serum patients

  4. 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

  5. anti-inflammatory markers

    Time frame: during one year

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

Secondary outcomes

  1. survival

    Time frame: during one year

    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.

Other outcomes

  1. Incidence of ventilatory support

    Time frame: during one year

    Change in respiratory functions with no need for ventilatory support

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 10, 2022
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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