A randomized, double-blind, placebo-controlled, two parallel groups, international multicenter trial to evaluate the effect of Plerixafor in acute respiratory failure related to COVID-19 (LEONARDO)
- Conditions
- acute respiratory failure related to COVID-19acute respiratory failure
- Registration Number
- NL-OMON51400
- Lead Sponsor
- 4Living Biotech SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 25
• 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.
Before or during the whole study, patients may have or will receive standard of
care i.e.,
routinely administered in such patients in the country study site as per
current health
authorities* recommendations (e.g., glucocorticoids, tocilizumab, remdesivir
*.).
• 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 Known cancer (solid or blood) in the last 5 previous years or previous
haematological disorders
(malignancies and other chronic conditions) or having received bone marrow
transplant,
• 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.
• E13 Patients with auto immune disease treated or not,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of patients with need for invasive mechanical ventilation or death<br /><br>between randomization and D28</p><br>
- Secondary Outcome Measures
Name Time Method