Patients with COVID-19 infection MedDRA version: 22.1 Level: LLT Classification code 10048847 Term: Lung infection NOS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Kevzara
Product Name: Kevzara
Product Code: [SAR153191]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sarilumab
CAS Number: 1189541-98-7
Current Sponsor code: SAR153191
Sponsors
ASST FATEBENEFRATELLI SACCO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years and 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
Exclusion criteria: • Age 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and 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.;Secondary Objective: Potenziale efficacia di sarilumab nella polmonite Covid-19: • Nei pazienti con febbre al basale, valutazione del tempo alla risoluzione della febbre, definita come temperatura corporea =36,6 ° C axilla, =37,8 ° C rettale o timpanica per almeno 48 ore senza antipiretici; • Valutazione della carica virale, sangue ed espettorato per COVID-19 prima della somministrazione di sarilumab, 48 ore e 96 ore dopo la somministrazione; • Valutazione della concentrazione plasmatica di Il-6, TNF-a, Il-10 e GM-CSF pre-trattamento e 96 e 120 ore dopo il trattamento; • Valutazione del tasso di progressione della frazione WBC di granulociti immaturi - IG - (conteggi assoluti e%) e dei parametri morfologici-funzionali definiti da: - complessità citoplasmatica - intensità di fluorescenza - dimensioni - ampiezza di distribuzione degli eventi su entrambi gli assi del citogramma WDF.;Primary end point(s): Proportion of patients who show an improvement of the respiratory function, described as =30% decrease in oxygen requirement compared to baseline.;Timepoint(s) of evaluation of this end point: Daily until discharge | — |
Countries
Italy
Contacts
Public ContactDipartimento di Scienze Cliniche -
ASST Fatebenefratelli Sacco
Outcome results
None listed