TOFAcitinib plus Hydroxycloroquine vs Hydroxycloroquine in patients with early onset SARS-CoV2 (COVID-19) interstitial pneumonia: a multicenter randomized controlled open label trial - Tofactinib+HYQ vs HYQ in early COVID-19 pneuminitis

AZIENDA OSPEDALIERO-UNIVERSITARIA OSPEDALI RIUNITI DI ANCONA0 个研究点目标入组 116 人开始时间: 2020年6月26日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•Age <18 ys or >65
•Patients in mechanical ventilation at time of admission
•Severe Hearth failure (NYHA 3 or 4)
•QTc > 470 ms or >500 ms in wide QRS patients
•Severe History of Chronic Ischemic Heart Disease, defined as history of Major Adverse Cardiovascular Event and/or recent (one year) revascularization.
•History of recurrent Deep Venous Thrombosis and Pulmonary Embolism or established thrombophilic conditions (e.g. history of anti-phospholipid antibodies, …)
•Active Bacterial or Fungal Infection
•Hematological cancer
•Metastatic or intractable cancer
•Pre-existent neurodegenerative disease
•Severe Hepatic Impairment,
•History of acute diverticular disease or intestinal perforation
•HBsAg positive and/or HBV-DNA positive patients
•Severe Renal Failure (Creatinine Clearance <30ml/h)
•Active Herpes zoster infection
•Patients with active or latent TB
•Severe anemia (Hb<9g/dl)
•Lymphocyte count below 750/mcl
•Neutrophil count below 1000/mcl
•Platelet count below 50000/mcl
•Pregnancy or Lactation
•History of intolerance to the experimental drugs or excipients
•Degenerative maculopathy or other relevant retinal disease
•Inability to give informed consent (severe transitory or permanent mental impairment, incapacitation)

发起方