An international, placebo-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of 150 mg XAV-19 infusion, in patients with moderate COVID-19: the EUROXAV study - EUROXAV Study

XENOTHERA0 个研究点目标入组 722 人开始时间: 2021年2月8日最近更新: 2021年9月13日

研究概览

暂无简介。

•I1) Male or female patient aged 18 years or over, weighing >50 Kg and <120 Kg, at the time of signing the informed consent,
•I2) Patient presenting in a specialized or an emergency unit
•I3) Patient presenting signs of pneumonia evidenced by at least 1 of the following: auscultation, chest X-Ray, CT scan OR presenting COVID-19 related symptoms having started less than 10 days prior to screening visit, including at least 2 of the following: fever, cough, sore throat or nasal discharge, dyspnea (shortness of breath), thoracic pain, headache or fatigue, myalgia, anosmia, dysgeusia, diarrhea, nausea
•I4) Patient with SpO2 > 90% (at ambient air)
•I5) Patient with a first positive SARS-CoV-2 test (RT-PCR, RT-qPCR or antigen test) in the last 10 days or at screening
•I6) Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at screening and use a highly effective1 birth control until 90 days after the administration of study drug
•I7) Non-vasectomized male patients having a female partner of childbearing potential must agree to use a highly effective method of contraception until 90 days after the administration of study drug,
•I8) Patient capable of giving 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 288
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 434

•E1) Patient with a positive SARS CoV-2 test (RT-PCR, RT-qPCR or antigen test) of more than 10 days before the screening visit
•E2) Patient with multiorgan failure
•E3) Patient requiring immediate Intensive Care Unit (ICU) hospitalization
•E4) Patient participating in another clinical trial with an investigative agent
•E5) Pregnancy or breastfeeding

发起方