COVID19, Sepsis or Other CausesPhase 1/2NCT04378920
A Study of Liposomal Trans Crocetin, LEAF-4L6715, in Patients With Acute Respiratory Distress Syndrome Due to COVID-19, Sepsis or Other Causes
A Phase 1/2 study testing LEAF-4L6715 in people with COVID19, Sepsis or Other Causes and Acute Respiratory Distress Syndrome, run by Institut de cancérologie Strasbourg Europe at 2 sites in France.
Trial summary
This is an open label phase II study of treatment with LEAF-4L6715 in patients who experience severe acute respiratory distress syndrome (ARDS) due to COVID-19, Sepsis or other Causes. The purpose of this study is to evaluate the improvement in PaO2/FiO2 by more than 25% in patients treated with LEAF-4L6715. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19, Sepsis or Other Causes, Acute Respiratory Distress Syndrome
- What is being tested?
- LEAF-4L6715
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Apr 2020to 24 Aug 2021
- Phase
- Phase 1/2
- 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
- Signed informed consent from the patient or patient's legal representative must be obtained prior to any procedures, as the likelihood of patients being able to provide consent is very limited
- Patients must be ≥ 18 years old
- Patient must have acute respiratory distress syndrome as defined, with a PaO2/FiO2 ratio of less than 200 mm Hg
- Patient must be under artificial ventilation support (including patient under OptiflowTM Nasal High Flow device or an equivalent device)
- Patient must have a life expectancy of at least 24 hours
- Patients should have normal liver function as defined by ALT, AST and alkaline phosphate less than 3 ULN for the institution
- Patient must have platelet count above >100,000 cells/mm3, hemoglobin > 8 g/dL and an absolute neutrophil count (ANC) of > 1000 cells/mm3
- Patients requiring dialysis due to renal impairment in cohort 3
Who cannot join
- Patient is enrolled in any other therapeutic clinical trial with the same endpoints. All observational studies or study with limited invasive methods (Pharmacokinetic studies, monitoring of virus charges studies, biological monitoring studies ….) are allowed
- Patient is pregnant or breast-feeding
- Patient has a known hypersensitivity to crocetins, LEAF-4L6715 or any of its excipients
- Patients with hemoglobinopathy
- Patients receiving extracorporeal membrane oxygenation (ECMO)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
About this study
This is an open label phase II study of treatment with LEAF-4L6715 in patients who experience severe acute respiratory distress syndrome (ARDS) due to COVID-19, Sepsis or other Causes. The purpose of this study is to evaluate the improvement in PaO2/FiO2 by more than 25% in patients treated with LEAF-4L6715.
Read the detailed description
Patient is treated with LEAF-4L6715, a liposomal transcrocetin. The liposomal formulation allows for a gradual release of the free drug, thereby facilitating less frequent dosing.
Pharmacokinetic assessment will be carried out to identify an optimal dose and schedule.
- Being tested
- LEAF-4L6715
- Medical subject headings
- COVID-19, Sepsis, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEAF-4L6715Drug
LEAF-4L6715
| Study group | Role | What they receive |
|---|---|---|
| 4L6715 | Experimental | exploring various doses of LEAF-4L6715 Receives: Drug: LEAF-4L6715 |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio
Measured: 24 hours
Secondary outcomes (2)
proportion of patients with a PaO2/FiO2 ratio above 200 mm Hg
Measured: 24, 48 and 72 hours
all cause mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start14 Apr 2020
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19, Sepsis or Other CausesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Collaborators
- LEAF4Life, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378920
- Sponsor's protocol ID
- 2020-003
- Other IDs
- 2020-001393-30, 2020-A00900-39
- Status last verified
- Dec 2021
- First submitted
- 5 May 2020
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Liposomal Trans Crocetin, LEAF-4L6715, in Patients With Acute Respiratory Distress Syndrome Due to COVID-19, Sepsis or Other Causes
- ClinicalTrials.gov ID
- NCT04378920
- Acronym / sponsor ID
- 2020-003
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Collaborators
- LEAF4Life, Inc.
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 7 May 2020 (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 is an open label phase II study of treatment with LEAF-4L6715 in patients who experience severe acute respiratory distress syndrome (ARDS) due to COVID-19, Sepsis or other Causes. The purpose of this study is to evaluate the improvement in PaO2/FiO2 by more than 25% in patients treated with LEAF-4L6715.
Detailed description
Patient is treated with LEAF-4L6715, a liposomal transcrocetin. The liposomal formulation allows for a gradual release of the free drug, thereby facilitating less frequent dosing.
Pharmacokinetic assessment will be carried out to identify an optimal dose and schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4L6715 | Experimental | Drug: LEAF-4L6715exploring various doses of LEAF-4L6715 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent from the patient or patient's legal representative must be obtained prior to any procedures, as the likelihood of patients being able to provide consent is very limited
- Patients must be ≥ 18 years old
- Patient must have acute respiratory distress syndrome as defined, with a PaO2/FiO2 ratio of less than 200 mm Hg
- Patient must be under artificial ventilation support (including patient under OptiflowTM Nasal High Flow device or an equivalent device)
- Patient must have a life expectancy of at least 24 hours
Key exclusion criteria (5 listed)
- Patient is enrolled in any other therapeutic clinical trial with the same endpoints. All observational studies or study with limited invasive methods (Pharmacokinetic studies, monitoring of virus charges studies, biological monitoring studies ….) are allowed
- Patient is pregnant or breast-feeding
- Patient has a known hypersensitivity to crocetins, LEAF-4L6715 or any of its excipients
- Patients with hemoglobinopathy
- Patients receiving extracorporeal membrane oxygenation (ECMO)
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 |
|---|---|---|
| LEAF-4L6715LEAF-4L6715 | Drug | 4L6715 |
Primary outcome
proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio
Time frame: 24 hours
2 secondary outcomes
proportion of patients with a PaO2/FiO2 ratio above 200 mm Hg
Time frame: 24, 48 and 72 hours
all cause mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LEAF-4L6715 in people with COVID19, Sepsis or Other Causes and Acute Respiratory Distress Syndrome, run by Institut de cancérologie Strasbourg Europe at 2 sites in France.
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 5 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: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
proportion of patients showing an increase of at least 25% of PaO2/FiO2 ratio (time frame: 24 hours). 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 16 Dec 2021.