A prospective, multicenter, randomized, parallel, double-blind, placebo-controlled phase IIb clinical trial to evaluate intravenous infusion of Defibrotide in the prevention and treatment of respiratory distress and cytokine release syndrome in patients with COVID-19. - DEFACOVID

FFIS0 个研究点目标入组 120 人开始时间: 2020年4月3日最近更新: 2020年4月14日

适应症

试验速览

暂无简介。

•? Patients of both sexes with an age greater than or equal to 18 years.
•? Patients with a diagnosis of SARS-CoV-2 infection confirmed by RT-PCR.
•? Patients with grade 4, 5 or 6 clinical status according to the WHO classification.
•- Grade 4: Hospitalized patients requiring oxygen therapy.
•- Grade 5: Hospitalized patients requiring high-flow oxygen therapy, non-invasive mechanical ventilation, or both.
•- Grade 6: Hospitalized patients requiring extracorporeal membrane oxygenation or invasive mechanical ventilation.
•? Patients with IL-6 levels equal to or greater than 3 times the value of normality
•? Potentially fertile patients should have a negative pregnancy test in serum (beta-HCG) or urine (evaluated between 2 and 1 days prior to administration of the study medication).
•? Patients who offer sufficient guarantees of adherence to the protocol.
•? Patients who give their written informed consent to participate in the study
•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

•? Patients with acute bleeding.
•? Patients with thrombolytic treatment and anticoagulant treatment at therapeutic doses.
•? Patients with an active malignant tumor.
•? Patients with severe systemic or neuropsychiatric diseases.
•? Patients with hypersensitivity to the active substance or to any of the excipients of the study drug.
•? Patients who are participating in other clinical trials.
•? Patients with an inability to understand informed consent.
•? Pregnant patientsb, in the postpartum period or in the period of active lactation.
•Physically fertile patients, UNLESS they are using a highly effective contraceptive method

发起方

FFIS