There is one clinical trial.
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.
Description: The proportion of subjects alive and free of respiratory failure at Day 28.
Measure: Effect of LB1148 on disease progression via measurement of the proportion of patients who are alive and free of respiratory failure. Time: 28 DaysDescription: 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)
Measure: Clinical status at fixed time points Time: Measured at 3, 5, 7, 8, 10, 14 and 28 DaysDescription: Length of hospital stay (live discharge)
Measure: Duration of hospital stay Time: 28 DaysDescription: Number and proportion of patients requiring admission to the intensive care unit
Measure: Measurement of the number and proportion of patients requiring admission to the intensive care unit (ICU) during hospitalization Time: 28 DaysDescription: Length of ICU stay
Measure: Duration of ICU stay Time: 28 DaysDescription: Number and proportion of patients requiring invasive mechanical ventilation
Measure: Invasive mechanical ventilation requirements Time: 28 DaysDescription: Length of time patients require invasive mechanical ventilation
Measure: Duration of invasive mechanical ventilation Time: 28 DaysDescription: The number and proportion of patients deceased at Day 28
Measure: All-cause 28-day mortality Time: 28 DaysDescription: The incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measure: Safety and tolerability of LB1148 Time: 28 Days