NCT04390217

LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia

A Phase 2 Study to Evaluate LB1148 for the Treatment of Pulmonary Dysfunction Associated With COVID-19 Pneumonia

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Leading BioSciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19
• Coronavirus Disease 2019
• Covid19
• COVID-19 Pneumonia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-10-31
• Primary completion: 2021-12-31
• Completion: 2022-03-31
• First posted: 2020-05-15
• Last updated: 2022-05-13

Regulatory

• FDA-regulated drug study