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Sarilumab Prefilled SyringeWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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D007239 Infection NIH 0.06

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There is one clinical trial.

Clinical Trials

1 Pilot Study on the Use of Sarilumab in Patients With COVID-19 Infection

Sarilumab is an anti-interleukin-6 human monoclonal antibody, such as tocilizumab, which is administered subcutaneously every two weeks for the treatment of moderate to severe active rheumatoid arthritis in adult patients. Despite the effectiveness reported for tocilizumab in the recently published experiences, the need to rapidly find alternative therapies to manage the complications of Covid-19 infection remains extremely high. The lack of clinical experience on the usage of sarilumab in such patients prevents the possibility of adopting early access programs for using commercially available sarilumab (prefilled syringe) packs in patients with severe Covid-19 pneumonia. The present study is aimed to generate a rapid, still robustly documented, evidence on the potential clinical efficacy and tolerability of a further IL-6R antagonist in Covid-19 pneumonia.

NCT04386239 COVID19 Drug: Sarilumab Prefilled Syringe
MeSH:Infection

Primary Outcomes

Description: Clinical efficacy of sarilumab in adult patients hospitalized due to severe Covid-19 pneumonia based on the proportion of patients who show an improvement of the respiratory function, described as ≥30% decrease in oxygen requirement compared to baseline (as defined as the ratio of O2 flow through the Venturi mask).

Measure: Proportion of patients who show an improvement of the respiratory function

Time: 6 weeks

Secondary Outcomes

Description: Evaluation of the time to resolution of fever, defined as body temperature ≤36.6°C axilla, ≤37.8°C rectal or tympanic for at least 48 hours without antipyretics in patients with fever at baseline.

Measure: Evaluation of the time to resolution of fever

Time: 6 weeks

Description: Evaluation of the viral load on blood and sputum for COVID-19

Measure: Evaluation of the viral load on blood and sputum for COVID-19

Time: Before administration of sarilumab, 48 hours and 96 hours after administration

Description: Evaluation of the plasma concentration of GM-CSF

Measure: Evaluation of the plasma concentration of GM-CSF

Time: Pre-treatment and 96 and 120 hours post-treatment

Description: Evaluation of the plasma concentration of Il-6

Measure: Evaluation of the plasma concentration of Il-6

Time: Pre-treatment and 96 and 120 hours post-treatment

Description: Evaluation of the plasma concentration of TNF-α

Measure: Evaluation of the plasma concentration of TNF-α

Time: Pre-treatment and 96 and 120 hours post-treatment

Description: Evaluation of the rate of progression of WBC fraction of immature granulocytes - IG - (absolute count).

Measure: Evaluation of the rate of progression of White Blood Cell (WBC) fraction

Time: 96 and 120 hours post-treatment

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