EUCTR2020-002056-20-FR进行中（未招募）1 期
FX06 to rescue acute respiratory distress syndrome during Covid-19 pneumonia : FX-COVID - FX-COVID
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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.Age = 18 years
- •2.SARS-CoV-2 induced pneumonia confirmed by a positive PCR test in nasopharyngeal swab or respiratory tract secretions
- •3. Acute respiratory distress syndrome (ARDS) according to Berlin criteria (bilateral pulmonary infiltrates on frontal chest x-ray, PaO2/FiO2 ratio =300 mmHg, objective assessment excluding hydrostatic pulmonary oedema)
- •4.Need for endotracheal intubation and mechanical ventilation
- •5.Informed consent by patient or legal representative According to the specifications of emergency consent, randomization without the close relative or surrogate consent could be performed.
- •6.Affiliated to a social security system
- •7.Highly effective method of contraception (oral contraception associated with inhibition of ovulation, intrauterine device or hormone releasing system, bilateral tubal occlusion, vasectomized partner or sexual abstinence for more than three months before inclusion) and negative highly sensitive pregnancy test, for women of childbearing potential
- •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 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1.Mechanically ventilation for more than 4 days
- •2.Patient receiving drugs interfering with inflammation: non-steroidal anti-inflammatory drugs, immunoglobulins.
- •3.Patients receiving chemotherapy, radiotherapy or immunotherapy for malignancy
- •4.Participation in another interventional clinical trial
- •5.Women pregnant or lactating
- •6.Patient moribund on the day of randomization, defined by a SAPS-II score>90
- •7.Contra-indication for vascular access implantation for transpulmonary thermodilution monitoring
- •8.Severe or terminal renal insufficiency (creatinine clearance <30 ml/min)
- •9.Severe hepatic insufficiency (hepatic SOFA score>2)
- •10.Severe cardiac insufficiency, with left ventricular ejection fraction<30%
- •11.Any history of severe allergic drug reaction (anaphylactic shock or allergic angioedema)
- •12.Persons deprived of their liberty by a judicial or administrative decision (guardianship or tutelage measure)
研究者
相似试验
已完成
2 期
FX06 to Rescue Acute Respiratory Distress Syndrome During Covid-19 PneumoniaArdsCovid19PneumoniaNCT04618042Assistance Publique - Hôpitaux de Paris50
已完成
不适用
Emergency and Acute Care for Respiratory Diseases beyond Sectoral SeparatioJ09-J18J20-J22J40-J47Influenza and pneumoniaOther acute lower respiratory infectionsChronic lower respiratory diseasesDRKS00011930Institut für Allgemeinmedizin, Charité - Universitätsmedizin Berlin472
进行中（未招募）
1 期
Mesenchymal stromal cells as a new treatment for a disease called ARDSAcute Respiratory Distress SyndromeEUCTR2017-000584-33-GBBelfast Health and Social Care Trust78
已完成
Unknown
Treatment of severe acute respiratory failure patients requiring Extracorporeal Membrane Oxygenation (ECMO)severe acute respiratory failure patients requiring treatment by the Extracorporeal Membrane Oxygenation (ECMO)JPRN-jRCT1092220327Getinge Group Japan K.K.20
已完成
3 期
Reducing acute severe respiratory events in health care workers during the Covid-19 pandemic with OM85Severe lower respiratory illnessCovid-19Respiratory - Other respiratory disorders / diseasesInfection - Other infectious diseasesACTRN12620000473965The University of Queensland61