Силтуксимаб (Siltuximab)
Международное непатентованное наименование
Силтуксимаб (Siltuximab)
Торговое наименование
Sylvant
Производитель, страна
Janssen Biotech, Inc., USA
Лекарственная форма
lyophilized powder in a single-dose vial, 100 mg & 400 mg
Механизм действия
SYLVANT is indicated for the treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
Публикации COVID-19
Giuseppe Gritti, Federico Raimondi, et al. Use of siltuximab in patients with COVID-19 pneumonia requiring ventilatory support. DOI: 10.1101/2020.04.01.20048561.
Zumla A, Hui DS, Azhar EI, Memish ZA, Maeurer M. Reducing mortality from 2019-nCoV: host-directed therapies should be an option. Lancet. 2020 Feb 22;395(10224):e35-e36. doi: 10.1016/S0140-6736(20)30305-6. Epub 2020 Feb 5.
Клинические исследования
1.
Название протокола
Phase 2, Randomized, Open-label Study to Compare Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID19 Pneumonia
Дата начала и окончания КИ
April 15, 2020 - May 20, 2020
Название организации, проводящей КИ
Fundacion Clinic per a la Recerca Biomédica
Страны
Spain
Фаза
II
Кол-во пациентов
200
2.
Название протокола
A Prospective, Randomized, Factorial Design, Interventional Study to Compare the Safety and Efficacy of Combinations of Blockade of Interleukin-6 Pathway and Interleukin-1 Pathway to Best Standard of Care in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure and Systemic Cytokine Release Syndrome
Дата начала и окончания КИ
April 2020 - December 2020
Название организации, проводящей КИ
University Hospital, Ghent
Страны
Belgium
Фаза
III
Кол-во пациентов
342
3.
Название протокола
An Observational Case-control Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications
Дата начала и окончания КИ
March 19, 2020 - May 19, 2020
Название организации, проводящей КИ
A.O. Ospedale Papa Giovanni XXIII
Страны
Italy
Фаза
-
Кол-во пациентов
50