COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04390217

Michael J Dawson

not reported

2020-05-15

Withdrawn

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

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.

2

Leading BioSciences, Inc

18

None

None

Severe disease at enrollment

6: Severe disease at enrollment

0

Effect of LB1148 on disease progression via measurement of the proportion of patients who are alive and free of respiratory failure.

None

Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 718, "treatment_name": "Lb1148", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]