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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ASST Fatebenefratelli Sacco

Criteria

Inclusion Criteria:

• Age ≥ 18 years and < 85 years.

• Documented (chest X-Ray or TC scan), severe (BCRSS ≥3 and <4) interstitial pneumonia with respiratory failure (requiring supplemental oxygen) with positive Covid-19 swab testing.

• Worsening of respiratory exchanges such as to require ventilation with Venturi mask >31% (6L/minute).

• Increased levels of D-dimer (> 1500 ng/mL) or D-dimer progressively increasing (over 3 consecutive measurements) and reaching ≥ 1000 ng/mL.

• Signed informed consent.

Exclusion Criteria:

• Age < 18 years or ≥ 85 years.

• AST / ALT > 5x Upper normal limit.

• Neutrophil count lower than 500 cells / mL.

• Platelet count lower than 50,000 cells / mL.

• Documented sepsis due to infections other than Covid-19.