EUCTR2020-001747-21-PT进行中（未招募）1 期
Impact of Montelukast as add on treatment to the novel coronavirus pneumonia (COVID-19): an investigator-initiated open labelled randomized controlled pragmatic trial
Instituto de Saúde Pública Universidade Porto0 个研究点目标入组 160 人开始时间: 2020年5月22日最近更新:
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
- 160
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
- •1.Admitted to a hospital with a diagnosis of moderate or severe COVID-19 pneumonia defined as:
- •a.moderate cases: showing fever and respiratory symptoms with radiological findings of pneumonia;
- •b.severe cases meeting any of the following criteria: i) respiratory distress (?30 breaths/ min); ii) oxygen saturation=93% at rest without oxygen inhalation; iii) PaO2/FiO2(fraction of inspired oxygen)=300mmHg; iv) with chest imaging that showed obvious lesion progression within 24-48 hours >50% shall be managed as severe cases
- •2.Subject, or legally authorized representative, provides written informed consent prior to the initiation of any study procedures.
- •3.Understands and agrees to comply with planned study procedures.
- •4.Agrees to the collection of oropharyngeal swabs.
- •5.Male or non-pregnant female adult > / = 18 years of age at the time of enrollment.
- •6.Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen collected < 72 hours prior to randomization. Note, 72 hours is not necessarily time from initial diagnosis. If > / = 72 hours since positive PCR, the PCR may be repeated to assess eligibility.
- •7.Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Admitted to a hospital with a diagnosis of critical type of COVID-19 pneumonia defined as any of the follow: i) requiring mechanical ventilation, ii) extracorporeal life support (ECMO, ECCO2R, RRT); iii) shock, iv) multiple organ dysfunction syndrome. Patients who are participating in another drug clinical trials.
- •2.Requiring dialysis.
- •3.Pregnancy or breast feeding.
- •4.Allergy to any study medication.
- •5.Severe basic diseases that affect survival, including uncontrolled malignant tumors that have metastasized and cannot be removed, blood diseases, cachexia, active bleeding, severe malnutrition, HIV, etc.;
- •6.Pulmonary tumors caused by obstructive pneumonia, severe interstitial fibrosis, alveolar proteinosis, allergic alveolitis.
- •7.Continued use of immunosuppressive agents or organ transplants in the last 6 months.
- •8.Expected deaths within 48 hours.
- •9.Clinicians judge inappropriate.
研究者
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