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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05411575
Recruitment Status : Recruiting
First Posted : June 9, 2022
Last Update Posted : September 16, 2022
Sponsor:
Information provided by (Responsible Party):
4P-Pharma ( 4Living Biotech )

Brief 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.


Condition or disease Intervention/treatment Phase
COVID-19 Acute Respiratory Distress Syndrome COVID-19 Drug: Plerixafor 20 MG/ML [Mozobil] Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : July 19, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : June 2023


Arm Intervention/treatment
Placebo Comparator: Placebo
continuous intravenous infusion for 7 days of Placebo
Other: Placebo
Placebo continuous intravenous infusion for 7 days

Experimental: Plerixafor
Plerixafor (Mozobil®) continuous intravenous infusion for 7 days
Drug: Plerixafor 20 MG/ML [Mozobil]
Plerixafor (Mozobil®) continuous intravenous infusion for 7 days




Primary Outcome Measures :
  1. 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) [ Time Frame: Day 1- Day 28 ]
    Proportion of patients with need for invasive mechanical ventilation or death between randomization and D28


Secondary Outcome Measures :
  1. To evaluate the efficacy of Plerixafor compared to placebo on Mortality between randomization and D28 [ Time Frame: Day 1-Day 28 ]
    Percentage of death (all-cause mortality)

  2. To evaluate the efficacy of Plerixafor compared to placebo on Mortality between randomization and D90 [ Time Frame: Day 1-Day 90 ]
    Percentage of death (all-cause mortality)

  3. To evaluate the efficacy of Plerixafor compared to placebo on Ventilator-free days between randomization and D28 [ Time Frame: Day 1-Day 28 ]
    Number of Ventilator-free days

  4. To evaluate the efficacy of Plerixafor compared to placebo on Duration of mechanical ventilation between randomization and D90 [ Time Frame: Day 1-Day 90 ]
    Duration of invasive mechanical ventilation in survivors

  5. To evaluate the efficacy of Plerixafor compared to placebo on Length of ICU stay between randomization and D90 [ Time Frame: Day 1-Day 90 ]
    Number of ICU stay days

  6. To evaluate the efficacy of Plerixafor compared to placebo on Respiratory function including FEV1, FVC, PaO2 and Transfer Lung Capacity for carbon monoxide (TLCO), 6-minute walk test [ Time Frame: Day 1-Day 90 ]
    Respiratory function at 3 months (FEV-1, FVC, PaO2, TLCO, 6-minute walk test)

  7. To evaluate the efficacy of Plerixafor compared to placebo on Clinical improvement [ Time Frame: Day 1, Day 8, Day 14 Day 28, Day 90 ]
    Ordinal Scale for Clinical Improvement (Clinical improvement: 7-point ordinal scale of the WHO Master Protocol (WHO, 2020). 1: not hospitalized up to 7:death)

  8. To evaluate the efficacy of Plerixafor compared to placebo on Level of consciousness [ Time Frame: Day 1-Day 8, Day 14, Day 28, Day 90 ]
    Level of consciousness (Alert, Voice, Pain, Unresponsive scale)

  9. To evaluate the efficacy of Plerixafor compared to placebo on SpO2 status [ Time Frame: Day 1-Day 8, Day 14, Day 28, Day 90 ]
    Measure of SpO2 via pulse oxymetry

  10. To evaluate the efficacy of Plerixafor compared to placebo on Respiratory/oxygenation status [ Time Frame: Day 1-Day 8, Day 14, Day 28, Day 90 ]
    Measure of Partial pressure of oxygen (PaO2), Partial pressure of carbon dioxide (PaCO2), Bicarbonate (HCO3),

  11. To evaluate the efficacy of Plerixafor compared to placebo on CRP, fibrinogen and D-dimers levels [ Time Frame: Day 1, Day 3, Day 8, Day 14, Day 28 ]
    Blood CRP, fibrinogen, D-dimers levels

  12. To evaluate the efficacy of Plerixafor compared to placebo on Safety AEs [ Time Frame: up to Day 90 ]
    Incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs), incidence of treatment on discontinuation and withdrawals due to TEAEs

  13. To evaluate the efficacy of Plerixafor compared to placebo on Safety/Lab tests [ Time Frame: up to Day 90 ]
    Quantification of White Blood Cells count and differential, Red Blood Cells count, hemoglobin level, Mean Corpuscular Volume, Reticulocyte and Platelet counts . Blood Chemistry (Creatinine, AST, ALT, total bilirubin, Potassium, total Calcium)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05411575


Contacts
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Contact: Keren Bismuth, PhD +33 9 50 72 97 68 keren@4p-pharma.com

Locations
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Bulgaria
Multiprofile Hospital for Active Treatment AD Haskovo Recruiting
Haskovo, Bulgaria, 6300
Multiprofile Hospital For Active Treatment Pazardzhik AD Recruiting
Pazardzhik, Bulgaria, 4400
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD Not yet recruiting
Plovdiv, Bulgaria, 4002
Multiprofile Hospital for Active Treatment Dr Ivan SeliminskiSliven AD Recruiting
Sliven, Bulgaria, 8800
University First Multiprofile Hospital for Active Treatment Sofia St John the Baptist Not yet recruiting
Sofia, Bulgaria, 1142
Military Medical Academy Multiprofile Hospital for Active Treatment Sofia Not yet recruiting
Sofia, Bulgaria, 1606
University Hospital for Active Treatment and Emergency Medicine NI Pirogov EAD Not yet recruiting
Sofia, Bulgaria, 1606
MHAT Sveta Anna Sofia AD Not yet recruiting
Sofia, Bulgaria, 1750
University Multiprofile Hospital for Active Treatment Prof Dr Stoyan Kirkovich AD Not yet recruiting
Stara Zagora, Bulgaria, 6000
France
Centre Hospitalier d'Argenteuil Recruiting
Argenteuil, France, 95100
Hôpital Saint André Recruiting
Bordeaux, France, 33000
Centre Hospitalier Départemental de Vendée - Les Oudairies Recruiting
La Roche-sur-Yon, France, 85000
Hôpital Haut-Lévêque Recruiting
Pessac, France, 33604
Hôpital Civil de Strasbourg Recruiting
Strasbourg, France, 67091
Sponsors and Collaborators
4Living Biotech
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Responsible Party: 4Living Biotech
ClinicalTrials.gov Identifier: NCT05411575    
Other Study ID Numbers: 4LB-LEO-P
First Posted: June 9, 2022    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 4P-Pharma ( 4Living Biotech ):
COVID-19
ARDS
Additional relevant MeSH terms:
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COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Plerixafor
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents