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LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia

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ClinicalTrials.gov Identifier: NCT04390217
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Leading BioSciences, Inc

Tracking Information
First Submitted Date  ICMJE May 13, 2020
First Posted Date  ICMJE May 15, 2020
Last Update Posted Date February 18, 2021
Estimated Study Start Date  ICMJE October 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2020)
  • 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)
  • Duration of hospital stay [ Time Frame: 28 Days ]
    Length of hospital stay (live discharge)
  • 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
  • Duration of ICU stay [ Time Frame: 28 Days ]
    Length of ICU stay
  • Invasive mechanical ventilation requirements [ Time Frame: 28 Days ]
    Number and proportion of patients requiring invasive mechanical ventilation
  • Duration of invasive mechanical ventilation [ Time Frame: 28 Days ]
    Length of time patients require invasive mechanical ventilation
  • All-cause 28-day mortality [ Time Frame: 28 Days ]
    The number and proportion of patients deceased at Day 28
  • Safety and tolerability of LB1148 [ Time Frame: 28 Days ]
    The incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia
Official Title  ICMJE A Phase 2 Study to Evaluate LB1148 for the Treatment of Pulmonary Dysfunction Associated With COVID-19 Pneumonia
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • COVID-19
  • Coronavirus Disease 2019
  • Covid19
  • COVID-19 Pneumonia
Intervention  ICMJE
  • 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)
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: LB1148
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04390217
Other Study ID Numbers  ICMJE LBS-COVID19-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Leading BioSciences, Inc
Study Sponsor  ICMJE Leading BioSciences, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael J Dawson, MD Leading BioSciences, Inc
PRS Account Leading BioSciences, Inc
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP