LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia

NCT04390217 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: LBS-COVID19-201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19; Coronavirus Disease 2019; COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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.

  28 Days

Secondary Outcomes (8)

• Clinical status at fixed time points

  Measured at 3, 5, 7, 8, 10, 14 and 28 Days

• Duration of hospital stay

  28 Days

• Measurement of the number and proportion of patients requiring admission to the intensive care unit (ICU) during hospitalization

  28 Days

• Duration of ICU stay

  28 Days

• Invasive mechanical ventilation requirements

  28 Days

Study Arms (2)

LB1148

EXPERIMENTAL

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.

Drug: LB1148

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

LB1148 DRUG

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.

Also known as: tranexamic acid (TXA)

LB1148

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patient or patient's legally authorized representative is willing and able to provide informed consent prior to performing any study-related procedures.
• 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.
• Patient has radiographic evidence of pulmonary infiltrate(s) or lung inflammation.

You may not qualify if:

• Participation in any other interventional clinical trial using an experimental treatment (drug or device) for COVID-19.
• Expected survival or time to withdrawal of life-sustaining treatments is expected to be \< 7 days.
• Patients with do not intubate orders.
• Patients who require invasive mechanical ventilation at the time of Screening.
• Patients who require renal replacement therapy (RRT) at the time of Screening.
• Patients with known aspiration problems.
• Has contraindications or potential risk factors to taking TXA. These include patients with:
• Known sensitivity to TXA;
• Recent craniotomy (past 30 days);
• Active cerebrovascular bleed;
• Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome);
• Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction
• Continuing use of a combined hormonal contraceptive and or combined hormonal replacement therapy (including combined hormonal pill, patch, or vaginal ring).
• Concomitant therapy with tissue plasminogen activators, Factor IX complex concentrates or anti-inhibitor coagulant concentrates.
• Known medical history of congenital or acquired thrombophilia such as, but not limited to patients with:

Sponsors & Collaborators

• Leading BioSciences, Inc: lead

MeSH Terms

Conditions

COVID-19

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Michael J Dawson, MD

  Leading BioSciences, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple blinding including the sponsor and all sponsor agents, subjects, investigators, care providers, and family members.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 15, 2020
• Study Start: October 31, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share