NCT04701658已完成2 期
A Prospective Cohort Study to Evaluate the Real-world Effectiveness of Bamlanivimab in Participants With Mild-to-moderate COVID-19 at High Risk for Progressing to Severe Illness, With Matched Controls
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
研究概览
简要总结
The purpose of this study is to find out whether bamlanivimab is able to stop COVID-19 from getting worse. Participants with mild-to-moderate COVID-19 will receive bamlanivimab via an injection into a vein. These participants will be matched to similar COVID-19 patients who received other treatment at a local medical center. All participants will be followed to learn how their disease responds. Participation could last about 3 months and includes two required visits to the study site, with the remainder of assessments performed by phone or by medical record review.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Are currently not hospitalized.
- •Have one or more mild or moderate COVID-19 symptoms.
- •Must have first positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral infection determination and as soon as possible within 10 days of symptom onset
- •Are males or non-breastfeeding females.
- •Contraceptive use by males or females should be consistent with local regulations for those participating in clinical studies.
- •Are at high risk for progressing to severe COVID-19 and/or hospitalization.
排除标准
- •Participants who:
- •are hospitalized due to COVID-19, OR
- •require oxygen therapy due to COVID-19, OR
- •require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
- •Have peripheral capillary oxygen saturation (SpO2) less than or equal to (≤) 90 percent on room air or arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) less than (<) 300, respiratory rate greater than or equal to (≥) 30 per minute, heart rate ≥125 per minute.
- •Have body weight <40 kilograms.
- •Require mechanical ventilation or anticipated impending need for mechanical ventilation.
- •Have known allergies to any of the components used in the formulation of the interventions.
- •Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention.
- •Have any comorbidity requiring surgery within <7 days, or that is considered life-threatening within 29 days.
- •Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
- •Have a history of a positive SARS-CoV-2 serology test.
- •Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study.
- •Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing.
- •Have received treatment with a SARS-CoV-2-specific monoclonal antibody, remdesivir, or other treatment for COVID-
- •Have received convalescent COVID-19 plasma treatment.
- •Have participated in a previous SARS-CoV-2 vaccine study.
- •Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
- •Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •Are breast-feeding.
研究组 & 干预措施
Bamlanivimab
Experimental
Participants received 700 milligram single intravenous infusion of Bamlanivimab.
干预措施: Bamlanivimab (Drug)
结局指标
主要结局
Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
时间窗: Baseline through Days 29, 60, and 90
Percentage of Participants who Experience COVID-19 Related Hospitalization or Death From Any Cause. Hospitalization is defined as ≥24 hours of acute care.
次要结局
- Percentage of Participants With a COVID-19-related Hospitalization(Baseline through Days 29, 60, and 90)
- Percentage of Participants With a COVID-related Emergency Department (ED) Visit(Baseline through Days 29, 60, and 90)
研究者
研究点 (1)
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