Plerixafor in Acute Respiratory Distress Syndrome Related to COVID-19 (Phase IIb)

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase IIb study, LEONARDO is a multicenter, randomized, double-blind, placebo- controlled, parallel group study, to assess the therapeutic efficacy and safety of Plerixafor in patients over 18 years of age,

• with acute respiratory failure related to COVID-19 and

• Recently admitted in ICU or equivalent structure (within 48 hours) for COVID-19 related respiratory failure

• without invasive mechanical ventilation and

• requiring oxygen support ≥ 5L/min to obtain a transcutaneous O2 saturation > 94% A total of 150 participants, will be randomized in a 2:1 ratio to receive either Plerixafor (n=100) or placebo (n=50) as a continuous IV infusion for 7 days (from D1 to D8) in addition to standard of care (e.g. glucocorticoids...).

Safety data will be reviewed by an independent Data and Safety Monitoring Board (DSMB) during the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 4Living Biotech
• Treatments: Plerixafor

Criteria

Inclusion Criteria:

• Male or female ≥ 18 years of age,

• Using contraceptive consistent with local regulations regarding the methods of contraception for those participating in clinical studies

• 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),

• 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)

• Not requiring immediate (within 24-36 hours) invasive mechanical ventilation according to investigator's judgment,

• Confirmed pneumoniae due to SARS-CoV-2, Laboratory-confirmed 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,

• Acute respiratory failure requiring oxygen support (≥ 5L/min) to achieve a transcutaneous oxygen saturation > 94%,

• Estimated glomerular filtration rate (eGFR) > 50 mL/min/1.73m2 by the CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration) equation.

Exclusion Criteria:

• Pregnancy or breast feeding,

• Anticipated transfer to another hospital, which is not a study site within 72 hours of randomisation,

• Need for Invasive mechanical ventilation at time of inclusion,

• Evidence of uncontrolled bacterial pneumopathy or active infection other than SARS-Cov-2 (laboratory confirmation),

• Primitive pulmonary arterial hypertension,

• Cardio-vascular co-morbidity:

• History of vascular ischemic events (myocardial infarction or stroke) or congestive heart failure or peripheral arterial disease,

• History or current significant cardiac rhythm disorders (e.g., ventricular tachycardia),

• Known medical history of proven symptomatic postural hypotension,

• 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,

• Inadequate haematological function defined by:

• Neutrophil count < 1.0 x 109/L,

• Haemoglobin < 9.0 g/dL (90 g/L),

• Platelets < 100 x 109/L,

• Kaliemia < 3.5 mmol/L and/or total Calcemia < 2.2 mmol/L,

• 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,

• Patients with known allergy to Plerixafor or its excipients.

• Previous (within 4 weeks) or current participation in another clinical study other than an observational study.

• Patients with auto immune disease treated or not,