PILOT STUDY ON THE USE OF SARILUMAB IN PATIENTS WITH COVID-19 INFECTIO

Phase 1

• Conditions: Patients with COVID-19 infection; MedDRA version: 22.1Level: LLTClassification code 10048847Term: Lung infection NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001745-40-IT
• Lead Sponsor: ASST FATEBENEFRATELLI SACCO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-24
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•Age < 18 years or = 85 years.
•AST / ALT > 5x ULN.
•Neutrophil count lower than 500 cells / mL.
•PTL count lower than 50,000 cells / mL.
•Documented sepsis due to infections other than Covid-19.
•Presence of serious co-morbidities (such as COPD, diabetes, or cardiomyopathies) likely to cause, according to the clinical judgment, an unfavorable outcome.
•Complicated diverticulitis or intestinal perforation.
•Immunosuppressive therapy due to organ transplant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified