COVID-19 Acute Respiratory Distress SyndromePhase 2LEONARDONCT05411575
Plerixafor in Acute Respiratory Distress Syndrome Related to COVID-19 (Phase IIb)
A Phase 2 study testing Plerixafor 20 MG/ML [Mozobil] in people with COVID-19 Acute Respiratory Distress Syndrome and COVID-19, run by 4Living Biotech at 14 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome, COVID-19
- What is being tested?
- Plerixafor 20 MG/ML [Mozobil]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 19 Jul 2022to Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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,
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Bulgaria9 sites
Multiprofile Hospital for Active Treatment AD Haskovo
Haskovo, 6300
Multiprofile Hospital For Active Treatment Pazardzhik AD
Pazardzhik, 4400
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, 4002
Multiprofile Hospital for Active Treatment Dr Ivan SeliminskiSliven AD
Sliven, 8800
University First Multiprofile Hospital for Active Treatment Sofia St John the Baptist
Sofia, 1142
Military Medical Academy Multiprofile Hospital for Active Treatment Sofia
Sofia, 1606
University Hospital for Active Treatment and Emergency Medicine NI Pirogov EAD
Sofia, 1606
MHAT Sveta Anna Sofia AD
Sofia, 1750
University Multiprofile Hospital for Active Treatment Prof Dr Stoyan Kirkovich AD
Stara Zagora, 6000
France5 sites
Centre Hospitalier d'Argenteuil
Argenteuil, 95100
Hôpital Saint André
Bordeaux, 33000
Centre Hospitalier Départemental de Vendée - Les Oudairies
La Roche-sur-Yon, 85000
Hôpital Haut-Lévêque
Pessac, 33604
Hôpital Civil de Strasbourg
Strasbourg, 67091
About this study
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.
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.
- Being tested
- Plerixafor 20 MG/ML [Mozobil], Placebo
- Keywords
- COVID-19, ARDS
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plerixafor 20 MG/ML [Mozobil]Drug
Plerixafor (Mozobil®) continuous intravenous infusion for 7 days
PlaceboOther
Placebo continuous intravenous infusion for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | continuous intravenous infusion for 7 days of Placebo Receives: Other: Placebo |
| Plerixafor | Experimental | Plerixafor (Mozobil®) continuous intravenous infusion for 7 days Receives: Drug: Plerixafor 20 MG/ML [Mozobil] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Proportion of patients with need for invasive mechanical ventilation or death between randomization and D28
Measured: Day 1- Day 28
Secondary outcomes (13)
To evaluate the efficacy of Plerixafor compared to placebo on Mortality between randomization and D28
Percentage of death (all-cause mortality)
Measured: Day 1-Day 28
To evaluate the efficacy of Plerixafor compared to placebo on Mortality between randomization and D90
Percentage of death (all-cause mortality)
Measured: Day 1-Day 90
To evaluate the efficacy of Plerixafor compared to placebo on Ventilator-free days between randomization and D28
Number of Ventilator-free days
Measured: Day 1-Day 28
To evaluate the efficacy of Plerixafor compared to placebo on Duration of mechanical ventilation between randomization and D90
Duration of invasive mechanical ventilation in survivors
Measured: Day 1-Day 90
To evaluate the efficacy of Plerixafor compared to placebo on Length of ICU stay between randomization and D90
Number of ICU stay days
Measured: Day 1-Day 90
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
Respiratory function at 3 months (FEV-1, FVC, PaO2, TLCO, 6-minute walk test)
Measured: Day 1-Day 90
To evaluate the efficacy of Plerixafor compared to placebo on Clinical improvement
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)
Measured: Day 1, Day 8, Day 14 Day 28, Day 90
To evaluate the efficacy of Plerixafor compared to placebo on Level of consciousness
Level of consciousness (Alert, Voice, Pain, Unresponsive scale)
Measured: Day 1-Day 8, Day 14, Day 28, Day 90
To evaluate the efficacy of Plerixafor compared to placebo on SpO2 status
Measure of SpO2 via pulse oxymetry
Measured: Day 1-Day 8, Day 14, Day 28, Day 90
To evaluate the efficacy of Plerixafor compared to placebo on Respiratory/oxygenation status
Measure of Partial pressure of oxygen (PaO2), Partial pressure of carbon dioxide (PaCO2), Bicarbonate (HCO3),
Measured: Day 1-Day 8, Day 14, Day 28, Day 90
To evaluate the efficacy of Plerixafor compared to placebo on CRP, fibrinogen and D-dimers levels
Blood CRP, fibrinogen, D-dimers levels
Measured: Day 1, Day 3, Day 8, Day 14, Day 28
To evaluate the efficacy of Plerixafor compared to placebo on Safety AEs
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
Measured: up to Day 90
To evaluate the efficacy of Plerixafor compared to placebo on Safety/Lab tests
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)
Measured: up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start19 Jul 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: No participants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4Living Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411575
- Sponsor's protocol ID
- 4LB-LEO-P
- Acronym
- LEONARDO
- Status last verified
- Apr 2023
- First submitted
- 15 May 2022
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05411575
- Acronym / sponsor ID
- LEONARDO / 4LB-LEO-P
- Keywords
- COVID-19, ARDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- 4Living BiotechIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebocontinuous intravenous infusion for 7 days of Placebo |
| Plerixafor | Experimental | Drug: Plerixafor 20 MG/ML [Mozobil]Plerixafor (Mozobil®) continuous intravenous infusion for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (19 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plerixafor 20 MG/ML [Mozobil]Plerixafor (Mozobil®) continuous intravenous infusion for 7 days | Drug | Plerixafor |
| PlaceboPlacebo continuous intravenous infusion for 7 days | Other | Placebo |
Primary outcome
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
13 secondary outcomes
To evaluate the efficacy of Plerixafor compared to placebo on Mortality between randomization and D28
Time frame: Day 1-Day 28
To evaluate the efficacy of Plerixafor compared to placebo on Mortality between randomization and D90
Time frame: Day 1-Day 90
To evaluate the efficacy of Plerixafor compared to placebo on Ventilator-free days between randomization and D28
Time frame: Day 1-Day 28
To evaluate the efficacy of Plerixafor compared to placebo on Duration of mechanical ventilation between randomization and D90
Time frame: Day 1-Day 90
To evaluate the efficacy of Plerixafor compared to placebo on Length of ICU stay between randomization and D90
Time frame: Day 1-Day 90
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
To evaluate the efficacy of Plerixafor compared to placebo on Clinical improvement
Time frame: Day 1, Day 8, Day 14 Day 28, Day 90
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
To evaluate the efficacy of Plerixafor compared to placebo on SpO2 status
Time frame: Day 1-Day 8, Day 14, Day 28, Day 90
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
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
To evaluate the efficacy of Plerixafor compared to placebo on Safety AEs
Time frame: up to Day 90
To evaluate the efficacy of Plerixafor compared to placebo on Safety/Lab tests
Time frame: up to Day 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plerixafor 20 MG/ML [Mozobil] in people with COVID-19 Acute Respiratory Distress Syndrome and COVID-19, run by 4Living Biotech at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Bulgaria, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.