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临床试验/EUCTR2020-002733-15-FR
EUCTR2020-002733-15-FR进行中（未招募）1 期

A RANDOMIZED, DOUBLE BLIND, MULTICENTER, PLACEBO CONTROLLED, PARALLEL GROUP, EXPLORATORY EFFICACY AND SAFETY STUDY OF GLENZOCIMAB IN SARS-Cov-2-RELATED ACUTE RESPIRATORY DISTRESS SYNDROME - GARDEN: Glenzocimab in SARS-Cov-2 Acute Respiratory DistrEss syNdome

ACTICOR BIOTECH0 个研究点目标入组 40 人开始时间: 2020年6月8日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
40
研究概览入排标准研究者记录与标识符相似试验

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. Male or female hospitalized patients = 18 years (i.e., at least 18 years old at the time of randomization) and < 80 years, having given their written consent.
  • •2. Having a positive RT-PCR test for COVID-19
  • •3. Presenting with symptoms of COVID-19, including:
  • •Shortness of breath or difficulty breathing
  • •OR at least 2 of the following
  • •Fever, defined as any body temperature 38ÅãC
  • •Repeated shaking with chills
  • •Muscle pain
  • •Sore throat
  • •New loss of taste or smell
  • •4. Presenting with signs of moderate but progressive pulmonary
  • •disease with:
  • •respiratory symptoms (cough, dyspnea, etc.),
  • •uni- or bilateral ground-glass opacities, or pulmonary
  • •infiltrates on chest radiograph and/or CT scan,
  • •clinical and biological evidence of progression over the past 48hrs.
  • •5. Presenting with one or several signs associated with the onset of ARDS such as:
  • •24/min = Respiratory rate (RR) < 30/min,
  • •90% < SpO2 = 93% in resting state,
  • •100 < PaO2/FiO2 = 200mmHg.
  • •6. Presenting with signs of a pro-thrombotic status characterized by
  • •a. D-Dimers = 0.5 µg/mL,
  • •b. and/or Troponin T > 2.5 µg/L
  • •c. and/or signs of micro-angiopathy on a vascular enhanced
  • •chest CT-scan 7. With one or more of the following biological markers of
  • •progression: • CRP =10 mg/L,
  • •LDH > 250 U/L,
  • •IL6 > 8 pg/mL,
  • •Lymphocyte count < 1x109/L,
  • •NT proBNP > 88 pg/mL,
  • •Pro-calcitonin > 0.5 ng/mL,
  • •Ferritin > 400 µg/L
  • •8. Effective birth control that should have been in place for at least 2 months in non-menopausal women and 4 months for men after
  • •IMP administration. Birth control methods considered to be highly effective include:
  • •combined (estrogen-progestogen) hormonal contraception
  • •associated with the inhibition of ovulation: oral,
  • •intravaginal, transdermal,
  • •progesterone-only hormonal contraception associated with
  • •the inhibition of ovulation: oral, injectable, implantable,
  • •intrauterine device,
  • •intrauterine hormone-releasing system,
  • •bilateral tubal occlusion,
  • •vasectomized partner.
  • •9. Women of child-bearing potential must have negative results of
  • •a urinary or plasma pregnancy test (serum HCG).
  • •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 30
  • •F.1.3 Elderly (>=65 years) yes
  • 另有 1 项未显示

排除标准

  • •1. Patients requiring immediate admission to the ICU,
  • •2. Patients requiring invasive mechanical ventilation,
  • •3. Obvious disseminated intravascular coagulation (DIC), with
  • •low platelet count (<100,000/mL), altered fibrinogen (elevated
  • •>2g/L or low <1g/L), prolonged PT > 12sec and/or aPTT >
  • •60sec, presence of fibrin degradation products in the plasma,
  • •with or without clinically visible hemorrhagic signs ,
  • •4. ARDS of another origin,
  • •5. Concomitant pulmonary infection (pneumoniae) with another
  • •agent, notably bacterial or fungal,
  • •6. Patients presenting with hemoglobin < 9g/L,
  • •7. Patients under immunosuppressive agents,
  • •8. Patients receiving an anti-cancer treatment (radiotherapy, chemotherapy, immunotherapy)
  • •9. Patients under aspirin = 100 mg/day,
  • •10. Patients under anticoagulant therapy (except heparin and lowmolecular weight heparin), and anti-Xa drugs achieving effective anticoagulation, as assessed by appropriate tests, or having received thrombolytics =24 hrs,
  • •11. Patients receiving NSAIDs or anti-platelet agents with platelet suppression within the past 7 days,
  • •12. Patients treated concomitantly with another monoclonal antibody (e.g. tocilizumab)
  • •13. Ischemic stroke or transient ischemic attack within the past year,
  • •14. Deep venous thrombosis or pulmonary embolism within the past year,
  • •15. Severe renal insufficiency (Grades 4-5) with a glomerular
  • •filtration rate <30mL/Min/1.73m2,
  • •16. One of the following severe organ failures:
  • •a. Hepatic with either Child Pugh score =C, or ASAT/ALAT =5 U.N.L,
  • •b. Cardiac with NYHA=Class II, unstable angina pectoris,
  • •myocardial infarct <1 year, supra-ventricular or ventricular
  • •arrhythmia,
  • •17. Hereditary tendency to bleeding or coagulopathy,
  • •18. Severe vascular disease (aneurysms, arterial surgery =6 months),
  • •19. Unhealed wounds, gastrointestinal ulcers or perforation =6
  • •20. Major surgery <28 days, other surgery within the past 7 days,
  • •21. Hemoptysis, GI bleeding, CNS bleeding <1 month,
  • •22. Platelet count <50,000/mm3 (50G/L),
  • •23. Absolute Neutrophil Count =1,000/mm3 (1.0G/L),
  • •24. Terminal illness, including cancer (life expectancy <3 months),
  • •25. Uncontrolled arterial hypertension (systolic blood pressure =185
  • •mmHg and/or diastolic blood pressure =110 mmHg despite appropriate antihypertensive therapy,
  • •26. Childbirth within <10 days,
  • •27. Pregnancy or breastfeeding,
  • •28. Prior cardiopulmonary resuscitation <10 days,
  • •29. Allergy or hypersensitivity to drugs of the same class
  • •30. Participation in another interventional clinical trial within 30
  • •days prior to the inclusion

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