A 2-part Clinical Study Including a First-in-Human, Open-label, Single Ascending Dose Part (Phase 1) Followed by a Randomised, Double-blind, Placebo-controlled Part (Phase 2) to Evaluate the Efficacy and Safety of XVR011 in Patients Hospitalised for Mild to Moderate COVID-19

ExeVir Bio0 个研究点目标入组 279 人开始时间: 2022年4月20日最近更新: 2022年4月25日

研究概览

暂无简介。

•- Is >=18 years of age inclusive, at the time of signing the informed consent.
•- Has ongoing SARS-CoV-2 infection confirmed by positive RT-PCR test and/or positive antigen test in a timeframe consistent with the current symptoms.
•- Had an onset of COVID-19 symptom(s) within 7 days prior to screening
•- Requires hospitalisation for medical care.
•- Has oxygen saturation > 93% (via pulse oximetry) on room air or with oxygen supplementation.
•- 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 112
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 167

•- Has respiratory rate >= 30 per minute, or heart rate = 125 per minute at hospitalisation.
•- Has severe COVID-19 requiring non-invasive or invasive mechanical ventilation and/or intensive care.
•- Has ongoing clinically significant thromboembolic event, according to Investigator.
•- Has any other medical condition, which in the opinion of the Investigator, would impact the safety of the subjects.
•- Has received an investigational or approved vaccination against SARS-CoV-2 within 30 days before study treatment start.
•- Has known allergy or hypersensitivity reaction to any monoclonal antibody or to any components of study treatment.
•- For WOCBP:
•o Pregnancy or a positive urine pregnancy test
•o Breastfeeding
•Exclusion Criteria only Applicable to Part 1
•- Has received or is receiving concomitant treatment with medicinal products with potential or demonstrated anti SARS CoV 2 (antiviral) activity, including but not limited to remdesivir, within 30 days prior to the study treatment administration.
•- Has morbid obesity (body mass index > 35 kg/m2), uncontrolled diabetes, cardiac insufficiency, uncontrolled high blood pressure, or any clinically significant (in the opinion of the Investigator) hepatic, pulmonary, gastrointestinal, genitourinary, endocrine, immunologic, metabolic, neurologic, or haematological disease.

发起方

ExeVir Bio