COVID-19Phase 2NCT04390217
LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia
A Phase 2 study testing LB1148 in people with COVID-19 and Coronavirus Disease 2019, run by Leading BioSciences, Inc.
Trial summary
This is a Phase 2, proof of concept, randomized, placebo-controlled, multicenter study to evaluate the ability of LB1148 to attenuate pulmonary dysfunction associated with COVID-19 pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Coronavirus Disease 2019, Covid19
- What is being tested?
- LB1148
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2021to 31 Mar 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
- Adult patients (18 years of age or older) with the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, confirmed via an established standard reverse transcriptase polymerase chain reaction (RT-PCR) assay.
- Patient or patient's legally authorized representative is willing and able to provide informed consent prior to performing any study-related procedures.
- Patient is hospitalized and requires some form of supplemental oxygen, e.g., non-invasive ventilation, high flow oxygen device, or oxygen by mask or nasal cannula.
- Patient has radiographic evidence of pulmonary infiltrate(s) or lung inflammation.
Who cannot join
- Participation in any other interventional clinical trial using an experimental treatment (drug or device) for COVID-19.
- Expected survival or time to withdrawal of life-sustaining treatments is expected to be < 7 days.
- Patients with do not intubate orders.
- Patients who require invasive mechanical ventilation at the time of Screening.
- Patients who require renal replacement therapy (RRT) at the time of Screening.
- Patients with known aspiration problems.
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- Has contraindications or potential risk factors to taking TXA. These include patients with:
- Known sensitivity to TXA;
- Recent craniotomy (past 30 days);
- Active cerebrovascular bleed;
- Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome);
- Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction
- Continuing use of a combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch, or vaginal ring).
- Concomitant therapy with tissue plasminogen activators, Factor IX complex concentrates or anti-inhibitor coagulant concentrates.
- Known medical history of congenital or acquired thrombophilia such as, but not limited to patients with:
- Sickle cell disease
- Nephrotic syndrome
- Factor V Leiden
- Prothrombin gene mutation
- Protein C or S deficiency
- Antithrombin III deficiency
- Antiphospholipid syndrome
- Patients with myeloproliferative disorders.
- Any other condition that, in the opinion of the treating Investigator, would preclude the patient from being an appropriate candidate for the study.
- Female patients who are pregnant or breastfeeding at the time of Screening.
About this study
Official title: A Phase 2 Study to Evaluate LB1148 for the Treatment of Pulmonary Dysfunction Associated With COVID-19 Pneumonia
This is a Phase 2, proof of concept, randomized, placebo-controlled, multicenter study to evaluate the ability of LB1148 to attenuate pulmonary dysfunction associated with COVID-19 pneumonia. The primary objective of this study is to determine if enteral administration of LB1148 will effect disease progression in hospitalized patients with moderate to severe COVID-19 via measurement of the proportion of subjects alive and free of respiratory failure at Day 28.
Read the detailed description
The purpose of this study is to establish the safety and tolerability, along with preliminary evidence of efficacy, of LB1148 compared to placebo in hospitalized patients with moderate to severe coronavirus disease (COVID-19). All patients will be randomized into one of two treatment groups (LB1148 or Placebo) in a 1:1 ratio, and stratified by peripheral capillary oxygen saturation (SpO2) ≥ 93% on room air vs. < 93% on room air, and by PF ratio (PaO2, arterial oxygen partial pressure, to FiO2, fractional inspired oxygen) of ≥ 300 mmHg vs. PF ratio of < 300 mmHg at the time of Screening. (If PaO2 cannot be measured or acquired, SpO2 may be substituted to calculate the PF ratio.) LB1148 contains 7.5 g tranexamic acid (TXA), polyethylene glycol (PEG), glucose, and electrolytes. A total of 700 mL of LB1148 will be administered enterally, as a split dose (350 mL, every 12 hours). Study drug is given as a single bolus, to be delivered orally or via nasogastric (NG) or orogastric (OG) tube. For those patients assigned to placebo, a total of 700 mL of placebo will be administered enterally, as a split dose (350 mL, every 12 hours). The placebo contains PEG, glucose, and electrolytes.
- Conditions
- COVID-19, Coronavirus Disease 2019, Covid19, COVID-19 Pneumonia
- Being tested
- LB1148, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB1148Drug
Also called tranexamic acid (TXA)
LB1148 is delivered orally/enterally, 700 mL per day split into two administrations of 350 mL, approximately 12 hours apart, for up to 7 days.
PlaceboDrug
Placebo is delivered orally/enterally, 700 mL per day split into two administrations of 350 mL, approximately 12 hours apart, for up to 7 days.
| Study group | Role | What they receive |
|---|---|---|
| LB1148 | Experimental | LB1148 contains 7.5 g TXA, polyethylene glycol (PEG), glucose, and electrolytes. A total of 700 mL of LB1148 Active will be administered daily as a split dose (350 mL, every 12 hours) for up to 7 days. LB1148 Active is given as a single bolus, to be delivered orally or enterally via NG/OG tube, and should be fully consumed or delivered within 2 hours of the start of administration. Receives: Drug: LB1148 |
| Placebo | Placebo comparator | Placebo contains polyethylene glycol (PEG), glucose, and electrolytes. A total of 700 mL of LB1148 Placebo will be administered daily as a split dose (350 mL, every 12 hours) for up to 7 days. LB1148 Placebo is given as a single bolus, to be delivered orally or enterally via NG/OG tube, and should be fully consumed or delivered within 2 hours of the start of administration. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of LB1148 on disease progression via measurement of the proportion of patients who are alive and free of respiratory failure.
The proportion of subjects alive and free of respiratory failure at Day 28.
Measured: 28 Days
Secondary outcomes (8)
Clinical status at fixed time points
Number and proportion of patients with improved clinical status as assessed by a 9-point ordinal scale of disease severity at fixed timepoints (Days 3, 5, 7, 8, 10, 14, 28)
Measured: Measured at 3, 5, 7, 8, 10, 14 and 28 Days
Duration of hospital stay
Length of hospital stay (live discharge)
Measured: 28 Days
Measurement of the number and proportion of patients requiring admission to the intensive care unit (ICU) during hospitalization
Number and proportion of patients requiring admission to the intensive care unit
Measured: 28 Days
Duration of ICU stay
Length of ICU stay
Measured: 28 Days
Invasive mechanical ventilation requirements
Number and proportion of patients requiring invasive mechanical ventilation
Measured: 28 Days
Duration of invasive mechanical ventilation
Length of time patients require invasive mechanical ventilation
Measured: 28 Days
All-cause 28-day mortality
The number and proportion of patients deceased at Day 28
Measured: 28 Days
Safety and tolerability of LB1148
The incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
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 posted15 May 2020
- Study start31 Oct 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Why it stopped: Company focused on other clinical programs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Model description
- All patients will be randomized into one of two treatment groups (LB1148 or Placebo) in a 1:1 ratio, and stratified by peripheral capillary oxygen saturation and by PF ratio at the time of Screening.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leading BioSciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J Dawson, MD, Study director, Leading BioSciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390217
- Sponsor's protocol ID
- LBS-COVID19-201
- Status last verified
- May 2022
- First submitted
- 13 May 2020
- Last updated
- 13 May 2022
- 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 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate LB1148 for the Treatment of Pulmonary Dysfunction Associated With COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04390217
- Acronym / sponsor ID
- LBS-COVID19-201
- Conditions
- COVID-19, Coronavirus Disease 2019, Covid19, COVID-19 Pneumonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company focused on other clinical programs
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Leading BioSciences, IncIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 15 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 a Phase 2, proof of concept, randomized, placebo-controlled, multicenter study to evaluate the ability of LB1148 to attenuate pulmonary dysfunction associated with COVID-19 pneumonia. The primary objective of this study is to determine if enteral administration of LB1148 will effect disease progression in hospitalized patients with moderate to severe COVID-19 via measurement of the proportion of subjects alive and free of respiratory failure at Day 28.
Detailed description
The purpose of this study is to establish the safety and tolerability, along with preliminary evidence of efficacy, of LB1148 compared to placebo in hospitalized patients with moderate to severe coronavirus disease (COVID-19). All patients will be randomized into one of two treatment groups (LB1148 or Placebo) in a 1:1 ratio, and stratified by peripheral capillary oxygen saturation (SpO2) ≥ 93% on room air vs. < 93% on room air, and by PF ratio (PaO2, arterial oxygen partial pressure, to FiO2, fractional inspired oxygen) of ≥ 300 mmHg vs. PF ratio of < 300 mmHg at the time of Screening. (If PaO2 cannot be measured or acquired, SpO2 may be substituted to calculate the PF ratio.) LB1148 contains 7.5 g tranexamic acid (TXA), polyethylene glycol (PEG), glucose, and electrolytes. A total of 700 mL of LB1148 will be administered enterally, as a split dose (350 mL, every 12 hours). Study drug is given as a single bolus, to be delivered orally or via nasogastric (NG) or orogastric (OG) tube. For those patients assigned to placebo, a total of 700 mL of placebo will be administered enterally, as a split dose (350 mL, every 12 hours). The placebo contains PEG, glucose, and electrolytes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All patients will be randomized into one of two treatment groups (LB1148 or Placebo) in a 1:1 ratio, and stratified by peripheral capillary oxygen saturation and by PF ratio at the time of Screening.
| Arm | Type | Receives |
|---|---|---|
| LB1148 | Experimental | Drug: LB1148LB1148 contains 7.5 g TXA, polyethylene glycol (PEG), glucose, and electrolytes. A total of 700 mL of LB1148 Active will be administered daily as a split dose (350 mL, every 12 hours) for up to 7 days. LB1148 Active is given as a single bolus, to be delivered orally or enterally via NG/OG tube, and should be fully consumed or delivered within 2 hours of the start of administration. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo contains polyethylene glycol (PEG), glucose, and electrolytes. A total of 700 mL of LB1148 Placebo will be administered daily as a split dose (350 mL, every 12 hours) for up to 7 days. LB1148 Placebo is given as a single bolus, to be delivered orally or enterally via NG/OG tube, and should be fully consumed or delivered within 2 hours of the start of administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (18 years of age or older) with the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, confirmed via an established standard reverse transcriptase polymerase chain reaction (RT-PCR) assay.
- Patient or patient's legally authorized representative is willing and able to provide informed consent prior to performing any study-related procedures.
- Patient is hospitalized and requires some form of supplemental oxygen, e.g., non-invasive ventilation, high flow oxygen device, or oxygen by mask or nasal cannula.
- Patient has radiographic evidence of pulmonary infiltrate(s) or lung inflammation.
Key exclusion criteria (25 listed)
- Participation in any other interventional clinical trial using an experimental treatment (drug or device) for COVID-19.
- Expected survival or time to withdrawal of life-sustaining treatments is expected to be < 7 days.
- Patients with do not intubate orders.
- Patients who require invasive mechanical ventilation at the time of Screening.
- Patients who require renal replacement therapy (RRT) at the time of Screening.
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 |
|---|---|---|
| LB1148Also: tranexamic acid (TXA)LB1148 is delivered orally/enterally, 700 mL per day split into two administrations of 350 mL, approximately 12 hours apart, for up to 7 days. | Drug | LB1148 |
| PlaceboPlacebo is delivered orally/enterally, 700 mL per day split into two administrations of 350 mL, approximately 12 hours apart, for up to 7 days. | Drug | Placebo |
Primary outcome
Effect of LB1148 on disease progression via measurement of the proportion of patients who are alive and free of respiratory failure.
Time frame: 28 Days
The proportion of subjects alive and free of respiratory failure at Day 28.
8 secondary outcomes
Clinical status at fixed time points
Time frame: Measured at 3, 5, 7, 8, 10, 14 and 28 Days
Duration of hospital stay
Time frame: 28 Days
Measurement of the number and proportion of patients requiring admission to the intensive care unit (ICU) during hospitalization
Time frame: 28 Days
Duration of ICU stay
Time frame: 28 Days
Invasive mechanical ventilation requirements
Time frame: 28 Days
Duration of invasive mechanical ventilation
Time frame: 28 Days
All-cause 28-day mortality
Time frame: 28 Days
Safety and tolerability of LB1148
Time frame: 28 Days
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 13 May 2022.
- Individual participant dataSharing planned: No
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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.
Michael J Dawson, MD study director
Leading BioSciences, Inc
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LB1148 in people with COVID-19 and Coronavirus Disease 2019, run by Leading BioSciences, Inc.
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 4 inclusion and 25 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 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Effect of LB1148 on disease progression via measurement of the proportion of patients who are alive and free of respiratory failure. (time frame: 28 Days). 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 13 May 2022.