EXPLORATORY EFFICACY AND SAFETY STUDY OF GLENZOCIMAB IN SARS-Cov-2-RELATED ACUTE RESPIRATORY DISTRESS SYNDROME
- Conditions
- Respiratory Distress Syndrome Related to SARS-Cov-2Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-002733-15-FR
- Lead Sponsor
- ACTICOR BIOTECH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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:
• Cough
OR
• Shortness of breath or difficulty breathing
OR at least 2 of the following
• Fever, defined as any body temperature 38ÅãC
• Chills
• Repeated shaking with chills
• Muscle pain
• Headache
• 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
F.1.3.1 Number of subjects for this age range 30
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
months,
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method