drugset / Trial / NCT04386239

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

NCT04386239

Phase 0 Withdrawn ASST Fatebenefratelli Sacco
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-01-01
Primary completion
2023-01-01
Completion
2023-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sarilumab Monoclonal antibody 200 mg Subcutaneous
Subject Sarilumab Monoclonal antibody 400 mg Subcutaneous

Indications