PACTR202107832151388Other2 期
A randomized, double-blind, placebo-controlled, multicenter study of ensovibep (MP0420) in ambulatory adult patients with symptomatic COVID-19 – The EMPATHY” Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- Other
- 入组人数
- 2,100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •1. Men or women = 18 years of age on the day of inclusion (no upper limit).
- •2. Presence of two or more COVID-19 symptoms and onset within 7 days prior to
- •dosing: Feeling hot or feverish, cough, sore throat, low energy or tiredness, headache,
- •muscle or body aches, chills or shivering, and shortness of breath.
- •3. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test).
- •4. Understand and agree to comply with the planned study procedures.
- •5. The patient or legally authorized representative give signed informed consent.
排除标准
- •1. Requiring hospitalization at time of screening, or at time of study drug administration.
- •2. Oxygen saturation (SpO2) = 93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) < 300, respiratory rate = 30 per minute, and heart rate = 125 per minute.
- •3. Known allergies to any of the components used in the formulation of the ensovibep or placebo.
- •4. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking intervention.
- •5. Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
- •6. Any co-morbidity requiring surgery within 7 days of dosing, or that is considered life-threatening within 29 days of dosing.
- •7. Prior or concurrent use of any medication for treatment of COVID-19, including antiviral agents, convalescent serum, or anti-viral antibodies. Purely symptomatic therapies (e.g., over-the-counter [OTC] cough medications, acetaminophen, and nonsteroidal anti-inflammatories [NSAIDs]) are permitted. Prior vaccination for COVID-19 is permitted.
研究者
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