Status:
WITHDRAWN
Study on the Use of Sarilumab in Patients With COVID-19 Infection
Lead Sponsor:
ASST Fatebenefratelli Sacco
Conditions:
COVID19
Eligibility:
All Genders
18-84 years
Phase:
EARLY_PHASE1
Brief 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 arthri...
Detailed Description
In February 2020, the emergence of the COVID-19 epidemic in Italy and, especially, in Lombardy, with a potential fatal outcome in a significant proportion of cases, determined the need for adopting ne...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04386239
Start Date
January 1 2021
End Date
January 1 2023
Last Update
February 3 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Divisione Clinicizzata di Malattie Infettive, ASST FBF-Sacco
Milan, MI, Italy, 20157