COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05411575

Not reported

Not reported

2022-06-09

Withdrawn

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

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,

2

4Living Biotech

18

100

Bulgaria;France

Severe disease at enrollment

6: Severe disease at enrollment

0

To demonstrate that Plerixafor is able to reduce the need for invasive mechanical ventilation or death in severe COVID-19 patients admitted in Intensive Care Unit (ICU)

None

Phase 2

[{"arm_notes": "", "treatment_id": 2367, "treatment_name": "Plerixafor", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]