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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
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.
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.
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.
Time frame: 28 Days
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)
Time frame: Measured at 3, 5, 7, 8, 10, 14 and 28 Days
Duration of hospital stay
Length of hospital stay (live discharge)
Time frame: 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
Time frame: 28 Days
Duration of ICU stay
Length of ICU stay
Time frame: 28 Days
Invasive mechanical ventilation requirements
Number and proportion of patients requiring invasive mechanical ventilation
Time frame: 28 Days
Duration of invasive mechanical ventilation
Length of time patients require invasive mechanical ventilation
Time frame: 28 Days
All-cause 28-day mortality
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The number and proportion of patients deceased at Day 28
Time frame: 28 Days
Safety and tolerability of LB1148
The incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: 28 Days