EUCTR2020-002567-57-GB进行中（未招募）1 期
To determine whether administration of almitrine bismesylate can ameliorate hypoxaemia in Covid-19 and augment effectiveness of supplementary oxygen therapy and respiratory support - Almitrine bismesylate in COVID-19
niversity of Oxford / Clinical Trials and Research Governance0 个研究点目标入组 112 人开始时间: 2020年10月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
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
- •Hospitalised patients
- •Male or female, aged 18 and above
- •Clinically confident or proven Covid-19 disease* who require respiratory support** and who have not undergone significant de-escalation of respiratory support*** (i.e. are not in a recovery phase).
- •Female participants of childbearing potential must be willing to use effective contraception for two weeks after final dose of IMP. Women will be advised to use a hormonal method, an intrauterine device (IUD) or intrauterine system (IUS), a barrier method or abstinence.
- •*A clinically confident diagnosis is made where there is either swab positivity for Covid-19, or where the clinical presentation (including any of symptoms, clinical chemistry (e.g. raised D-dimer, raised CRP) and radiology (CXR, CT or ultrasound findings)) is consistent with likely Covid-19 infection. A pre-planned subgroup analysis will compare the primary outcome for those with swab positive and clinically likely” disease.
- •**At the time of recruitment, patients will be at least moderate oxygen therapy (>4 l/min O2 flow to mask or nasal cannulae; FiO2 > 0.3 for Venturi mask) to maintain pulse oximeter saturation, SpO2, in the target range set by the treating clinician. Other higher levels of oxygen support (including higher doses of oxygen, non-invasive respiratory support (continuous positive airway pressure (CPAP), high-flow nasal oxygen, or bi-level non-invasive positive pressure ventilation (NIPPV)) and invasive mechanical ventilation via an endotracheal tube can all be included, but patients are excluded if they have received >72 hours of invasive mechanical ventilation during their current illness.
- •***De-escalation of respiratory support is defined as a significant reduction in respiratory support that maintains saturation within the treating physicians’ target range within 24 hours of inclusion to this study. A significant reduction is any change in mode of oxygen delivery (i.e. intubated to non-invasive ventilation, non-invasive ventilation to standard oxygen therapy, or reduction of standard wall” oxygen of more than 3 litres / min). Changes less than this will not be considered to be significant.
- •Additional Inclusion Criteria for the Physiological Sub-Study
- •Arterial line in place for clinical care
- •Receiving either non-invasive respiratory support or invasive mechanical ventilation for which the inspired oxygen fraction can be measured.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 92
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Female participant who is pregnant, lactating or planning pregnancy during the course of the trial(women of childbearing potential as determined by the clinician must have a negative urine pregnancy test)
- •Pre-existing significant liver disease or a baseline AST or ALT which is >3x the upper limit of normal.
- •A previously established diagnosis of significant pulmonary hypertension defined as a resting pulmonary artery pressure of >50 mmHg on right heart catheter or echocardiography.
- •Received invasive mechanical ventilation for >72h during current illness, at the time of recruitment into the study
- •In the clinicians’ view, expected to survive <24 hours
- •Patients who, in the absence of Covid-19, would be unable to give informed consent.
- •Hypersensitivity to almitrine
研究者
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