UMEM Research Studies

Study TitleStudy DatesSponsorStatusPrimary Investigator(s)Other Investigator(s)
A Single-Blind, Randomized Study Comparing the Efficacy and Safety of a Single Dose of TNX-1300 to Placebo with Usual Care (UC) for the Treatment of Signs and Symptoms of Acute Cocaine Intoxication in Emergency Department (ED) Subjects 12/01/2023 to 12/31/2024 Tonix Pharmaceuticals, Inc. Not yet recruiting Gentry Wilkerson


Cocaine abuse and dependence and their sequelae are significant problems globally and in the United States. According to the US Centers for Disease Control and Prevention (CDC), in 2021 the number of overdose deaths involving cocaine reached 24,900 individuals. Cocaine-related emergency department (ED) visits are associated with chest pain, arrhythmias, myocardial ischemia, systolic hypertension, exacerbation of asthma, agitation, and seizures. However, there is currently no product licensed to treat cocaine intoxication.  

Based on its non-clinical efficacy profile, TNX-1300 shows promise as a novel compound for treating the cause of cocaine intoxication rather than the symptoms only. Thus, this is a single-blind, randomized study to investigate the efficacy and safety of TNX-1300 as a medical intervention to treat acute cocaine intoxication in the ED setting.  


Study Objectives:  

Primary: To evaluate the efficacy of TNX-1300 in the treatment of cocaine intoxication via blood pressure (BP) 60 minutes after intravenous (IV) administration in the ED setting.  

Secondary: To further evaluate the efficacy of TNX-1300 in the treatment of cocaine intoxication via assessment of BP, electrocardiograms (ECGs), and the Stimulant Intoxication Scale (SIS) at selected time points after IV administration in the ED setting. ID: NCT06045793
cocaine, Tonix
Microparticle Levels in ACE-inhibitor Induced Angioedema - Completed 04/01/2021 to 06/20/2024 N/A Completed Gentry Wilkerson
Stephen Thom

The overall goal of this study is to determine whether the levels of microparticles may be elevated in patients with angioedema that develops as a result of the use of the class of blood pressure medications, ACE inhibitors.

Angioedema, ACE, ACE-inhibitor, Microparticles
Percutaneous Ultrasound Gastrostomy technique - Completed 08/01/2019 to 07/12/2023 CoapTech Completed Gentry Wilkerson
Daniel Haase
Kami Windsor
WanTsu Wendy Chang

A single-center, non-randomized, non-blinded feasibility study to evaluate the performance, safety and tolerability of the Percutaneous Ultrasound Gastrostomy (PUG) procedure that utilizes a novel device in conjunction with widely available ultrasound technology. ID: NCT03956277
Gastrostomy, Percutaneous Ultrasound Gastrostomy, PUG, Feeding tube
ARREST PNEUMONIA ARrest RESpiraTory failure due to PNEUMONIA 12/07/2022 to - Funded by: National Heart, Lung, and Blood Institute (NHLBI) National Institutes of Health (NIH) ; INDE Sponsor: Joseph Levitt, MD & Emir Festic, MD Recruiting Kami Windsor
Gentry Wilkerson


Pneumonia is the leading infectious cause of hospitalization and death in the United States, with associated medical costs exceeding $10 billion annually. When patients require intensive care unit (ICU) level care, mortality exceeds 30% and survivors often require prolonged hospital stays and suffer from long-term disability. The host response to pneumonia is characterized by release of inflammatory cytokines that activate vascular endothelium and recruit neutrophils to help contain local infection. However, dysregulated inflammation can perpetuate injury leading to loss of endothelial and epithelial integrity and flooding of alveoli with protein rich edema fluid, which can lead to loss of lung compliance, refractory hypoxemia, and ultimately acute respiratory failure (ARF) and acute respiratory distress syndrome (ARDS). Loss of barrier function can also contribute to dissemination of local infection leading to septic shock and multiorgan dysfunction, which can cause ARF independent of ARDS. Currently, other than antibiotics and supportive care, there are no established treatments directly targeting the underlying lung injury that occurs with severe pneumonia. However, corticosteroids have been shown to reduce inflammation and preserve alveolar barrier function, while beta-agonists increase alveolar fluid clearance and preserve vascular permeability.  

Primary Objective 

To establish the efficacy of early treatment with an inhaled corticosteroid combined with a beta-agonist vs. placebo for the prevention of ARF in hospitalized participants with pneumonia and hypoxemia. 

Secondary Objective 

To identify baseline clinical and biological characteristics impacting risk of ARF due to pneumonia and impacting variable response to treatment. ID: NCT04193878
A Randomized, Double-Blind, Placebo Controlled Dose Ranging Study of Auxora in Patients with Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (CARPO) - Completed 03/02/2023 to - CalciMedica, Inc. Completed Gentry Wilkerson


Acute pancreatitis (AP) is an acute inflammatory process of the pancreas with varying involvement of local tissues and/or more remote organ systems. Due to the dynamic nature of the disease, it leads to wide-ranging outcomes that evolve rapidly in any given patient with little predictability. 

There is no prescribed order of events that the disease course follows, beyond the basic concept of an early (usually <1-2 weeks) and a late (>1-2 weeks) phase, with the former characterised by varying degrees of pancreatic and systemic inflammation, and the latter by an anergic phase that can make patients susceptible to infection. There are currently two primary aims in the initial treatment of patients with AP. The first aim is to provide supportive therapy, and to treat specific complications that may occur. The second aim is to limit the severity of pancreatic inflammation, necrosis, and systemic inflammatory response syndrome (SIRS). There is currently no approved pharmaceutical treatment for AP, regardless of the severity of the disease. Patients are generally managed with supportive care, including fluid replacement, painkillers, oxygen, feeding via a tube or into a vein, and antibiotics.  

Primary Objectives 

  • To assess the dose response and efficacy of three different dose levels of Auxora in patients with AP and accompanying SIRS; 

  • To assess the time to medically indicated discharge in patients who are responders to early tolerance of solid food intake versus non-responders. ID: NCT04681066
CARPO, pancreatitis
Auxora for the Treatment of AKI and Modulation of Injurious “Crosstalk” with the Lung: A Randomized Control Trial (KOURAGE) 06/21/2024 to - CalciMedica, Inc. Recruiting Gentry Wilkerson
Mark Sutherland


Acute kidney injury (AKI) describes a sudden decrease in the glomerular filtration rate and is clinically diagnosed by an increase in serum creatinine and/or a decrease in urine output. AKI occurs in up to 20% of hospitalized patients in high income countries and its development heralds an increased risk of mortality that worsens as the stage of AKI becomes greater. Survivors of AKI continue to face an increased risk of mortality and morbidity even after discharge. In addition, survivors of AKI face multiple long term medical complications such as the development or exacerbation of chronic kidney disease (CKD), hypertension, cardiovascular disease, and cerebrovascular disease. As a general principle, the management of AKI currently centers on the identification of the cause and the avoidance of aggravating insults. A clinical phenotype with a high risk of mortality and morbidity are patients with AKI with associated acute hypoxemic respiratory failure (AHRF). Patients with AKI are twice as likely to develop AHRF than patients without AKI. There is significant lung and kidney “crosstalk” that necessitates management strategies that alleviate injury, clinical or subclinical, in both these organs. An ideal therapeutic for AKI associated with AHRF, therefore, would be one that rapidly enters the lung and kidney, reduces a broad range of inflammatory cytokines, breaks the feedback loop between T-cells, neutrophils, and macrophages, and protects the pulmonary and renal endothelium. Auxora is such a therapeutic given its ability to rapidly enter both the lung and kidney, decrease inflammatory cytokines, improve GFR, and protect pulmonary endothelium. 


Primary Objective 

  • To assess the efficacy of Auxora in treating patients with severe AKI 


Secondary Objective 

  • To assess the safety and tolerability of Auxora in patients with severe AKI 


Key Inclusion Criteria 

  • The patient has developed Stage 2 or Stage 3 AKI. 

  • The patient has a documented PaO2/FiO2 (P/F) ≤ 300 in the prior 24 hours, either imputed from SpO2 or obtained from an arterial blood gas, that is not explained by cardiogenic pulmonary edema or volume overload, and is being treated with high flow nasal cannula with minimum flow rate ≥ 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanical ventilation. 


Key Exclusion Criteria 

  • The patient has a do not resuscitate or do not intubate directive. 

  • The patient has chronic lung disease that requires supplemental non-invasive oxygen as an outpatient or home mechanical ventilation. The use of noninvasive mechanical ventilation to treat obstructive sleep apnea is not an exclusion. 

  • The patient has catecholamine resistant shock and has required ≥ 0.2 ug/kg/min of norepinephrine or equivalent for the prior 6 hours. 

  • The patient has started or is expected to start kidney replacement therapy (KRT) in the next 12 hours. 

  • The patient has a direct bilirubin level > 3.0 mg/dL or both a direct bilirubin level ≥ 2.0 mg/dL and an INR ≥ 1.7. 

  • Patient has a known history of: 

  • Organ transplant 

  • HIV infection 

  • Hepatitis B infection 

  • Current treatment with   

  • Chemotherapy  

  • Immunosuppressive medications or immunotherapy   

 ID: NCT06374797
Auxora, AKI, ARF