acute respiratory failure related to COVID-19 acute respiratory failure
Conditions
Interventions
Plerixafor (Mozobil®) 30 microgrammes/kg/hour continuous intravenous infusion
for 7 days or Placebo similar modalities for infusion.
Sponsors
4Living Biotech SAS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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 *.).
Exclusion criteria
Exclusion criteria: • 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 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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with need for invasive mechanical ventilation or death between randomization and D28 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Percentage of death (all-cause mortality) • Number of Ventilator-free days • Duration of invasive mechanical ventilation in survivors • Number of ICU stay days • Respiratory function at 3 months (FEV-1, FVC, PaO2, TLCO, 6-minute walk test) • Ordinal Scale for Clinical Improvement (7 point-WHO scale) • Level of consciousness (Alert, Voice, Pain, Unresponsive scale) • SpO2 measured via pulse oxymetry and arterial blood gas: Partial pressure of oxygen (PaO2), Partial pressure of carbon dioxide (PaCO2), Bicarbonate (HCO3), Oxygen saturation (O2 Sat), pH, Base excess (when performed before intubation) • Blood CRP, fibrinogen, D-dimers levels • Incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs), • Incidence of Plerixafor discontinua-tion and withdrawals due to TEAEs • WBC count and differential, RBC count, hemoglobin level, MCV, Reticulocyte and Platelet counts • Blood Chemistry (Creatinine, AST, ALT, total bilirubin, K, total Ca) | — |
Countries
Netherlands
Outcome results
None listed