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 Bio BV0 个研究点目标入组 279 人开始时间: 2021年5月27日最近更新: 2021年7月26日

研究概览

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•- 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 invasive 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 patient.
•- Has received an investigational or approved vaccination against SARSCoV-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.

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