EUCTR2020-001768-27-FR进行中（未招募）1 期
STUDY OF THE EFFICIENCY OF NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE GERONIMO 19 - GERONIMO19
CH Versailles0 个研究点目标入组 39 人开始时间: 2020年4月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 39
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
- •- Man or woman aged 75 and over
- •- SARS-coV2 infection confirmed by RT-PCR or thoraco-pulmonary CT
- •- Hospitalized in the acute general geriatrics unit of the Versailles Hospital Center
- •- Patient rejected from resuscitation
- •- Saturation = 95% under oxygen therapy> 5 L / min (i.e. PaO2 / FiO2=200mmHg according to the Berlin definition of ARDS) by means of a nasal cannula, a high concentration facial mask or another device similar oxygen distribution
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 39
排除标准
- •- Patient under palliative care
- •- Patient with contraindication to IV polyvalent Ig
- •at. Hypersensitivity to the active substance or to any of the excipients (L-proline)
- •b. Hypersensitivity to human immunoglobulins, especially when the patient has anti-IgA antibodies,
- •vs. Patients with type I or II hyperprolinemia
- •- Patient under guardianship or curatorship
- •- Patient receiving another experimental treatment as part of an interventional study
- •- Moderate to severe dementia known: it must have been diagnosed before hospitalization and is defined by an MMSE <20/30 or a neuropsychological assessment with a diagnosis made.
- •- Patient not affiliated with a social security system in France
- •- ADL patients <4/6 and / or IADL <6/8
研究者
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