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

NCT05057221 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: HUM00195034
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19 Pneumonia

Keywords

Uproleselan; Selectin Inhibitor

Outcome Measures

Primary Outcomes (2)

• Safety of Uproleselan - as Measured by Serious Adverse Events

  Descriptive statistics will be calculated for quantitative safety data

  Up to 28 days

• Safety of Uproleselan- as Measured by Frequency of Serious Adverse Events

  Frequency counts will be compiled for classification of qualitative safety data.

  Up to 28 days

Secondary Outcomes (12)

• Change in the Progression to Acute Respiratory Failure for Patients With a Baseline PaO2/FiO2 >= 200

  Enrollment, 15 days

• Number of Patients Alive Who Are Free of Respiratory Failure

  Up to 28 days

• All-cause Mortality

  Up to 28 days

• Time to Change Oxygenation

  during hospitalization; hospital stay ranged from 2 to 10 days

• Number of Patients Requiring Mechanical Ventilation

  Up to 28 days

Study Arms (1)

Uproleselan

EXPERIMENTAL

Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL.

Drug: Uproleselan

Interventions

Uproleselan DRUG

Uproleselan 20 mg/kg BID up to maximum dose of 2500 mg, infused IV over 20 minutes on days 1-7 or until hospital discharge. It should be administered intravenously (IV) into a peripheral line, a central catheter, or a peripherally inserted central line catheter (PICC). Infusion should take place at a steady rate over a period of 20 minutes ±2 minutes using a syringe pump or IV pump.

Uproleselan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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); https://www.covid19treatmentguidelines.nih.gov/therapeutic-management/
• 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.

Sponsors & Collaborators

• Lena Napolitano, MD: lead
• GlycoMimetics Incorporated: collaborator

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

uproleselan

Results Point of Contact

• Title: Lena M. Napolitano MD
• Organization: University of Michigan

lenan@med.umich.edu

734-615-4775

Study Officials

• Lena Napolitano, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director and Professor of Surgery

Model Details: This is a prospective, interventional, single-arm, open label trial, with 1:1 matched de-identified retrospective control cohort.

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: September 27, 2021
• Study Start: November 12, 2021
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: July 10, 2023
• Results First Posted: July 10, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)