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LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia

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: NCT04390217
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Leading BioSciences, Inc

Brief 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. 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.

Condition or disease Intervention/treatment Phase
COVID-19 Coronavirus Disease 2019 Covid19 COVID-19 Pneumonia Drug: LB1148 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple blinding including the sponsor and all sponsor agents, subjects, investigators, care providers, and family members.
Primary Purpose: Treatment
Official Title: A Phase 2 Study to Evaluate LB1148 for the Treatment of Pulmonary Dysfunction Associated With COVID-19 Pneumonia
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: LB1148
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.
Drug: LB1148
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.
Other Name: tranexamic acid (TXA)

Placebo Comparator: Placebo
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.
Drug: Placebo
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical status at fixed time points [ Time Frame: Measured at 3, 5, 7, 8, 10, 14 and 28 Days ]
    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)

  2. Duration of hospital stay [ Time Frame: 28 Days ]
    Length of hospital stay (live discharge)

  3. Measurement of the number and proportion of patients requiring admission to the intensive care unit (ICU) during hospitalization [ Time Frame: 28 Days ]
    Number and proportion of patients requiring admission to the intensive care unit

  4. Duration of ICU stay [ Time Frame: 28 Days ]
    Length of ICU stay

  5. Invasive mechanical ventilation requirements [ Time Frame: 28 Days ]
    Number and proportion of patients requiring invasive mechanical ventilation

  6. Duration of invasive mechanical ventilation [ Time Frame: 28 Days ]
    Length of time patients require invasive mechanical ventilation

  7. All-cause 28-day mortality [ Time Frame: 28 Days ]
    The number and proportion of patients deceased at Day 28

  8. Safety and tolerability of LB1148 [ Time Frame: 28 Days ]
    The incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)



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:

  1. 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.
  2. Patient or patient's legally authorized representative is willing and able to provide informed consent prior to performing any study-related procedures.
  3. 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.
  4. Patient has radiographic evidence of pulmonary infiltrate(s) or lung inflammation.

Exclusion Criteria:

  1. Participation in any other interventional clinical trial using an experimental treatment (drug or device) for COVID-19.
  2. Expected survival or time to withdrawal of life-sustaining treatments is expected to be < 7 days.
  3. Patients with do not intubate orders.
  4. Patients who require invasive mechanical ventilation at the time of Screening.
  5. Patients who require renal replacement therapy (RRT) at the time of Screening.
  6. Patients with known aspiration problems.
  7. Has contraindications or potential risk factors to taking TXA. These include patients with:

    1. Known sensitivity to TXA;
    2. Recent craniotomy (past 30 days);
    3. Active cerebrovascular bleed;
    4. Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome);
    5. Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction
    6. Continuing use of a combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch, or vaginal ring).
    7. Concomitant therapy with tissue plasminogen activators, Factor IX complex concentrates or anti-inhibitor coagulant concentrates.
  8. Known medical history of congenital or acquired thrombophilia such as, but not limited to patients with:

    1. Sickle cell disease
    2. Nephrotic syndrome
    3. Factor V Leiden
    4. Prothrombin gene mutation
    5. Protein C or S deficiency
    6. Antithrombin III deficiency
    7. Antiphospholipid syndrome
  9. Patients with myeloproliferative disorders.
  10. Any other condition that, in the opinion of the treating Investigator, would preclude the patient from being an appropriate candidate for the study.
  11. Female patients who are pregnant or breastfeeding at the time of Screening.

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): NCT04390217


Contacts
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Contact: Inge K Bear, MS, CCRA 858-775-8293 inge.bear@leadingbiosciences.com
Contact: Brian K Wenzel, MS, CCRA 408-440-9545 brian.wenzel@leadingbiosciences.com

Sponsors and Collaborators
Leading BioSciences, Inc
Investigators
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Study Director: Michael J Dawson, MD Leading BioSciences, Inc
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Responsible Party: Leading BioSciences, Inc
ClinicalTrials.gov Identifier: NCT04390217    
Other Study ID Numbers: LBS-COVID19-201
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants