LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia

• Status: Not yet recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leading BioSciences, Inc
• Treatments: Tranexamic Acid

Criteria

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.