ISRCTN11713182进行中（未招募）未知
To determine whether administration of almitrine bismesylate can ameliorate hypoxaemia in COVID-19 and augment the effectiveness of supplementary oxygen therapy and respiratory support
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 116
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
- 性别
- All
入选标准
- •1. Hospitalised patients
- •2. Male or female, aged 18 and above
- •3. 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)
- •4. Female participants of childbearing potential must be willing to use effective contraception for two weeks after the 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 the 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:
- •1. Arterial line in place for clinical care
- •2. Receiving either non-invasive respiratory support or invasive mechanical ventilation for which the inspired oxygen fraction can be measured
排除标准
- •1. 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)
- •2. Pre-existing significant liver disease or a baseline AST or ALT which is >3x the upper limit of normal
- •3. A previously established diagnosis of significant pulmonary hypertension defined as a resting pulmonary artery pressure of >50 mmHg on right heart catheter or echocardiography
- •4. Received invasive mechanical ventilation for > 72 h during current illness, at the time of recruitment into the study
- •5. In the clinicians’ view, expected to survive < 24 hours
- •6. Patients who, in the absence of COVID-19, would be unable to give informed consent
- •7. Hypersensitivity to almitrine
- •8. A previously established diagnosis of right ventricular dysfunction that is clinically significant in the opinion of the treating physician
- •9. Hyperlactataemia (lactate >2mM)
研究者
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