Safety, Tolerability and Efficacy of Uproleselan (GMI-1271) in Patients With COVID-19 Pneumonia

  • End date
    Nov 15, 2023
  • participants needed
  • sponsor
    Lena Napolitano, MD
Updated on 15 December 2021


The purpose of this study is to find out whether the drug uproleselan can help patients with severe COVID-19 pneumonia. Investigators will study both the side effects of the drug and assess if the drug will help patients recover more quickly and slow down the progression of acute respiratory failure.


Soluble E-selectin is a significant biomarker for ARDS. Soluble E-selectin also has pro-inflammatory properties further releasing cytokines and promoting its synthesis and the continued influx of neutrophils. Small molecule glycomimetic antagonists of E-selectin (rivipansel and uproleselan) are 500- to 1000-fold more potent inhibitors of E-selectin and have shown activity and no measurable toxicity in human clinical trials for other indications. Treatment with these E-selectin inhibitors reduced the levels of soluble E-selectin in the bloodstream which occurs during recovery of ARDS. Thus antagonists of E-selectin which include glycomimetic antagonists and more specifically, rivipansel (GMI-1070) and uproleselan (GMI-1271), may be used to treat COVID-19 patients with respiratory symptoms that may lead to ARDS

Primary Objective:

Safety of uproleselan in patients with severe COVID-19 pneumonia.

Secondary Objectives:

To evaluate if treatment with uproleselan administered intravenously in addition to the best available therapy according to institutional guidelines is able to reduce the progression of acute respiratory failure, in patients with severe COVID-19 pneumonia.

  • To evaluate proportion of patients alive and free of respiratory failure through Day 28
  • To evaluate overall survival and all-cause mortality at day 15 and 28.
  • To evaluate changes in the COVID ordinal outcomes scale.
  • To assess adverse events to evaluate the safety of uproleselan.
  • To assess ventilator-free days, ICU-free days, oxygen, vasopressor free days.
  • To evaluate changes in D-dimer.

Exploratory Objectives:

  • To examine the correlation of plasma soluble E-selectin concentrations with clinical outcomes.
  • To examine the correlations of other biomarkers of interest with clinical outcome.

Condition COVID-19 Pneumonia
Treatment Uproleselan
Clinical Study IdentifierNCT05057221
SponsorLena Napolitano, MD
Last Modified on15 December 2021


Yes No Not Sure

Inclusion Criteria

Documented COVID-19 pneumonia: defined as upper respiratory tract specimen (nasopharyngeal swab (NPS) or viral throat swab) positive for COVID-19 and/or imaging at computed tomography scan suggestive of COVID-19 pneumonia
Confirmed coronavirus (SARS-CoV-2) (positive real-time reverse transcription polymerase chain reaction test (RT-PCR) for SARS-CoV-2 within 72 hours) enrolled ≤ 48 hours of need for supplemental oxygen
Currently hospitalized requiring supplemental oxygen
Have severe COVID-19 according to the World Health Organization (WHO) Interim Guidance with confirmation by real-time RT-PCR assay. The enrollment criteria with one of the following: respiratory distress, respiratory rate (RR) ≥30 beats/min; oxygen saturation level less than 93% in resting state; or partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) ≤ 300 mmHg
Willing and able to participate in all required evaluations and procedures

Exclusion Criteria

In the opinion of at least two investigators, unlikely to survive for >48 hours from screening
Severe chronic respiratory disease (e.g. Chronic obstructive pulmonary disease or other) requiring supplemental oxygen and/or having required mechanical ventilation pre-COVID-19 infection
Concurrent enrollment in a COVID related interventional drug trial. Use of remdesivir, steroids, and convalescent plasma are permitted along with other standard of care therapies for COVID.37
Currently on invasive mechanical ventilation
Hypotension defined as systolic blood pressure < 90 mmHg on two sequential readings at least 4 hours apart
Total Bilirubin ≤ 3 x upper limit of normal (ULN), Creatinine Clearance ≥ 30 mL/min/1.73m2
Pregnant or breastfeeding
Known diagnosis of an acute thrombosis on admission
Concurrent dual antithrombotic therapy (aspirin or P2Y12 inhibitor plus anticoagulation to treat deep venous thrombosis or pulmonary embolism (single antiplatelet or anticoagulant agent at prophylactic dose is permitted)
Concomitant use of thrombolytic therapy
Concomitant therapeutic systemic anticoagulant therapy (e.g. heparin, warfarin, direct thrombin inhibitors and direct factor Xa inhibitors). As per NIH Guidelines: Hospitalized adults with COVID-19 should receive Venous thromboembolism (VTE) prophylaxis per the standard of care for other hospitalized adults (AIII). Anticoagulant or antiplatelet therapy should not be used to prevent arterial thrombosis outside of the usual standard of care for patients without COVID-19 (AIII); <>
History of recent major bleeding, defined in accordance with the criteria of the International Society on Thrombosis and Hemostasis (ISTH)
History of bleeding disorder thought to impose excessive bleeding risk as per investigator discretion
Hemodynamic instability, defined as inability to maintain mean arterial pressure
Hypersensitivity to the active substance or to any of the excipients of uproleselan
Any physical examination findings and/or history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
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