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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-19

Study Completion Date

2022-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19 Acute Respiratory Distress Syndrome COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

continuous intravenous infusion for 7 days of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo continuous intravenous infusion for 7 days

Plerixafor

Plerixafor (Mozobil®) continuous intravenous infusion for 7 days

Group Type EXPERIMENTAL

Plerixafor 20 MG/ML [Mozobil]

Intervention Type DRUG

Plerixafor (Mozobil®) continuous intravenous infusion for 7 days

Interventions

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Plerixafor 20 MG/ML [Mozobil]

Plerixafor (Mozobil®) continuous intravenous infusion for 7 days

Intervention Type DRUG

Placebo

Placebo continuous intravenous infusion for 7 days

Intervention Type OTHER

Eligibility Criteria

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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,

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No