Phase 2, randomized, controlled, open label multi-center study to assess efficacy and safety of DFV890 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function

ovartis Farmacéutica S.A0 个研究点目标入组 120 人开始时间: 2020年7月22日最近更新: 2021年3月8日

研究概览

暂无简介。

•Clinically diagnosed with the SARS-CoV-2 virus
•Hospitalized with COVID-19-induced pneumonia
•Impaired respiratory function, defined as peripheral oxygen saturation (SpO2) =93% on room air or partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) <300 millimeter of mercury (mmHg)
•APACHE II score of =10 at time of randomization
•C-reactive protein (CRP) =20 mg/L and/or ferritin level =600 µg/L
•Body weight mass index of =18 to <40kg/m2
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•Suspected active or chronic bacterial (including Mycobacterium tuberculosis), fungal, viral, or other infection (besides SARS-CoV-2)
•In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
•Intubated prior to randomization
•Have received either oral anti-rejection, or immunomodulatory drugs within the past 2 weeks, or immunomodulatory therapeutic antibodies within the 5 half-lives or 30 days from randomization (whichever is longer), with the exception of hydroxychloroquine, chloroquine or corticosteroids at doses up to and including prednisolone 10mg daily or equivalent
•Treatment with a prohibited drug within 5 half-lives or 30 days (whichever is longer) of randomization or during the course of the study
•Serum alanine transaminase (ALT) or aspartate transaminase (AST) >5 times upper limit of normal detected within 24 hours at screening or at baseline or other evidence of severe hepatic impairment (Child-Pugh Class C)
•Absolute peripheral blood neutrophil count of =1000/mm3
•Estimated glomerular filtration rate (eGFR) =30 mL/min/1.73m2

发起方

ovartis Farmacéutica S.A