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.
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.
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.
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.
Michael J Dawson, MD, Study Director
Leading BioSciences, Inc