Plerixafor in acute respiratory distress syndrome related to covid-19 (Phase IIb)
- Conditions
- Severe COVID-19MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.1Level: PTClassification code 10084380Term: COVID-19 pneumoniaSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-001245-13-NL
- Lead Sponsor
- 4Living Biotech SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
• I1 Male or female = 18 years of age,
• I2 Using contraceptive consistent with local regulations regarding the methods of contraception for those participating in clinical studies,
• I3 Willing and able to provide written informed consent (or provided by legally acceptable representative if he/she is present and if in line with local regulations),
• I4 Admitted in ICU within 48 hours before randomization for COVID-19 related respiratory failure.
? ICU or equivalent medical structure according to country specificities e.g., Acute Respiratory Care Unit, High Dependency Care Unit if they can provide:
? continuous IV infusion,
? continuous ECG, respiratory rate, percutaneous oxygen saturation screen monitoring
? high flow nasal oxygen
• I5 Not requiring immediate (within 24-36 hours) invasive mechanical ventilation according to investigator's judgment,
• I6 Confirmed pneumoniae due to SARS-CoV-2 with Laboratoryconfirmed SARS-CoV-2 infection as determined by RT-PCR (in nasopharynx or throat samples) or other commercial or public health assay in any specimen, performed within 2 weeks prior to randomization,
• I7 Acute respiratory failure requiring oxygen support (= 5L/min) to achieve a transcutaneous oxygen saturation > 94%,
• I8 Estimated glomerular filtration rate (eGFR) > 50 mL/min/1.73m² by the CKD-EPI (Chronic Kidney Disease – Epidemiology Collaboration) equation.
Patients vaccinated against SARS-CoV-2 can be included in the study.
During the whole study, patients will receive standard of care for ethical reasons (e.g. glucocorticoids)
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
• E1 Pregnancy or breast feeding,
• E2 Anticipated transfer to another hospital, which is not a study site within 72 hours of randomisation,
• E3 Need for Invasive mechanical ventilation at time of inclusion,
• E4 Evidence of uncontrolled bacterial pneumopathy or active infection other than SARS-Cov-2 (laboratory confirmation),
• E5 Primitive pulmonary arterial hypertension,
• E6 Cardio-vascular co-morbidity:
o History of vascular ischemic events (myocardial infarction or stroke) or congestive heart failure or peripheral arterial disease,
o History or current significant cardiac rhythm disorders (e.g., ventricular tachycardia),
o Known medical history of proven symptomatic postural hypotension,
• E7 Evolutive cancer including acute and chronic leukaemia,
• E8 Inadequate haematological function defined by:
o Neutrophil count < 1.0 x 109/L,
o Haemoglobin < 9.0 g/dL (90 g/L),
o Platelets < 100 x 109/L,
• E9 Kaliemia < 3.5 mmol/L and/or total Calcemia < 2.2 mmol/L,
• E10 Inadequate hepatic function defined by Aspartate aminotransferase (AST) and/or Alanine Aminotransferase (ALT) > 3 x upper limit of normal (ULN) and/or Total bilirubin > 2 x ULN,
• E11 Patients with known allergy to Plerixafor or its excipients.
• E12 Previous (within 4 weeks) or current participation in another clinical study other than an observational study.
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