EUCTR2020-002982-33-SE进行中（未招募）1 期
An open-label, multicenter study to evaluate the efficacy, safety and tolerability of PDNO (nitrosooxypropanol) infusion in COVID-19 patients with acute pulmonary hypertension
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Attgeno AB
- 入组人数
- 16
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. Ability to understand and willing to sign an informed consent form after information at the pre-screening visit.
- •2. Male and female patients, age at least 18 years on the date of the informed consent at the time of the pre-screening visit.
- •3. Diagnosed with COVID-19 at admission to the ICU and, at the ICU, sedated and intubated.
- •4. Diagnosed with echocardiographic signs of pulmonary artery systolic pressure (PASP) >40 mmHg, as estimated by doppler defined echocardiography using a modified Bernoulli equation: PASP ˜ 4 (tricuspid regurgitant jet velocity)2 + CVP. After insertion of the PAC, a MPAP =20 mmHg will allow continued participation and start of PDNO infusion. If MPAP is <20 mm Hg, the patient is considered a screen failure and may be replaced.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1.History of chronic PH, as judged by the Investigator at screening*
- •2.Known New York Heart Association (NYHA) Functional Class III or IV symptoms (pre-Covid 19) at screening.*
- •3.Left heart failure with ejection fraction (EF) < 35 % at screening
- •4.Acute coronary syndrome (non ST elevation myocardial infarction [non-STEMI], ST elevation myocardial infarction [STEMI], unstable angina pectoris [AP]), myocardial infarction, stroke, transient ischemic attack (TIA), AV block III within 3 months prior to informed consent or QTcF >450ms at the time of screening.*
- •5.Body Mass Index (BMI) > 45 kg/m2 at screening*
- •6.Estimated glomerular filtration rate (eGFR) < 30 mL/min at screening
- •7.Any cardiac dysfunction (malignant arrhythmia, acute myocarditis, valve dysfunction or tamponade) which, in the opinion of the investigator, may put the patient at increased risk because of participation in the study
- •8.The need of norepinephrine infusion of > 0.25 µg/kg/min, or the use of two vasopressors at screening to keep the patient hemodynamically stable
- •9.MetHb >3% at screening
- •10.PCO2 > 7 at screening
- •11.Indication of liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN) at screening
- •12.Haemoglobin <80 g/dL at screening
- •13.Thrombocytopenia (platelet count <80000/mm3) at screening
- •14.Prothrombin time International ratio (INR) > 1.4 at screening
- •15.Pregnancy, or a positive pregnancy test at screening (for fertile women only)
- •16.Ongoing daily treatment the last 3 days with non-steroidal anti-inflammatory drugs (NSAIDs, excluding low dose, i.e. 75 mg, acetylsalicylic acid), new oral anticoagulants (NOACs), warfarin, heparin, clopidogrel (last 5 days). Low molecular weight heparin (LMWH) is not an exclusion criterion. Any use of PDE5 inhibitors (sildenafil, tadalafil, vardenafil and avanafil) within 48 hours prior to the administration of PDNO.
- •17.Known active malignancy within the past 3 years except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated.*
- •18.History of allergy/hypersensitivity to PD or ongoing allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to PDNO.*
- •19.History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the study, or influence the results or the ability to participate in the study.*
- •20.Participation in any interventional clinical study or has been treated with any investigational research products within 30 days or 5 half-lives, whichever is longer, prior to the initiation of screening.*
- •*evaluated at pre-screening
研究者
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