EUCTR2020-005299-36-BE进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 279
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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 8 days prior to screening; except for dyspnoea and/or tachypnoea for which an onset within 2 days prior to screening is applicable
- •- Requires hospitalisation for medical care.
- •- Has oxygen saturation = 91% (via pulse oximetry) on room air at rest.
- •- 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
排除标准
- •- Has a resting respiratory rate >= 30 per minute, or heart rate = 125 per minute at hospitalisation.
- •- Has severe COVID-19 requiring non-invasive (e.g. high flow) or
- •invasive mechanical ventilation and/or intensive care treatment.
- •- Has ongoing clinically significant thromboembolic event or
- •coagulopathy, according to clinical, laboratory and/or radiological
- •assessment.
- •- 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 14 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 renal impairment with estimated creatinine clearance < 60
- •mL/min/1.73 m2 .
- •- 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.
研究者
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