LB1148 for Pulmonary Dysfunction Associated With COVID-19 Pneumonia
COVID-19, Coronavirus Disease 2019, Covid19
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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:
- Sickle cell disease
- Nephrotic syndrome
- Factor V Leiden
- Prothrombin gene mutation
- Protein C or S deficiency
- Antithrombin III deficiency
- Antiphospholipid syndrome
- Patients with myeloproliferative disorders.
- Any other condition that, in the opinion of the treating Investigator, would preclude the patient from being an appropriate candidate for the study.
- Female patients who are pregnant or breastfeeding at the time of Screening.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
LB1148
Placebo
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.
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.