NCT04603651No Longer Available不适用
Expanded Access Information for Physicians for Bamlanivimab (LY3819253) Emergency Investigational New Drug [EIND]
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reside in a country where there are ongoing Lilly-sponsored clinical trials (currently this is only the United States)
- •Present within 10 days of symptom onset
- •Have severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) confirmed by reverse transcription polymerase chain reaction (RT-PCR) within the last three days
- •Participants greater than or equal to (≥) 65 years of age OR
- •Participants ≥ 12 years of age who weigh at least 40 kilograms AND have at least one of the following:
- •Chronic kidney disease
- •Chronic obstructive pulmonary disease (COPD) or other chronic lung disease
- •Immunocompromised state (weakened immune system or on immunomodulatory medications)
- •Obesity (body mass index [BMI] of 35 or higher)
- •Serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies
- •Sickle cell disease
- •Diabetes mellitus (Types 1 or 2)
排除标准
- •Require hospitalization greater than (>) 24 hours or hospice care. Residents in long term care or skilled nursing facilities that meet the inclusion criteria and are not on mechanical ventilation will be considered
- •Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease
研究者
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