Trial Outcomes & Findings for Safety, Tolerability and Efficacy of Uproleselan (GMI-1271) in Patients With COVID-19 Pneumonia (NCT NCT05057221)

NCT ID: NCT05057221

Last Updated: 2023-07-10

Results Overview

Descriptive statistics will be calculated for quantitative safety data

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Up to 28 days
• Results posted on: 2023-07-10

Participant Flow

Participant milestones

Measure	Uproleselan Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.
Age, Continuous	56.5 years STANDARD_DEVIATION 13.7 • n=6 Participants
Sex: Female, Male Female	2 Participants n=6 Participants
Sex: Female, Male Male	4 Participants n=6 Participants
Region of Enrollment United States	6 participants n=6 Participants
Body Mass Index (BMI	37.21 Kg/m^2 STANDARD_DEVIATION 10.36 • n=6 Participants
E-selectin Plasma Concentrations	15.83 nanograms divided by milliliters STANDARD_DEVIATION 6.479 • n=6 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Descriptive statistics will be calculated for quantitative safety data

Outcome measures

Measure

Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.

Safety of Uproleselan - as Measured by Serious Adverse Events

0 Serious Adverse Events

PRIMARY outcome

Timeframe: Up to 28 days

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

Outcome measures

Measure

Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.

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

0 daily events

SECONDARY outcome

Timeframe: Enrollment, 15 days

Patients with a baseline PaO2/FiO2 >= 200: progression of respiratory failure is defined by:

1. severe gas transfer deficit (PaO2/FiO2 < 200);

2. persistent respiratory distress while receiving oxygen (persistent marked dyspnea, use of accessory respiratory muscles, paradoxical respiratory movements); The rate will be calculated as the proportion of patients who experienced at least one of the events above by day+15 from treatment start.

Outcome measures

Measure

Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.

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

0 Participants

SECONDARY outcome

Timeframe: Up to 28 days

Number of patients alive and free of acute respiratory failure which required initiation of mechanical ventilation

Outcome measures

Measure

Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.

Number of Patients Alive Who Are Free of Respiratory Failure

6 Participants

SECONDARY outcome

Timeframe: Up to 28 days

All-cause hospital mortality

Outcome measures

Measure

Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.

All-cause Mortality

0 Participants

SECONDARY outcome

Timeframe: during hospitalization; hospital stay ranged from 2 to 10 days

Number of days it took to reduce their oxygen requirements

Outcome measures

Measure

Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.

Time to Change Oxygenation

2 Days Standard Deviation 1

SECONDARY outcome

Timeframe: Up to 28 days

Number of patients requiring mechanical ventilation

Outcome measures

Measure

Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.

Number of Patients Requiring Mechanical Ventilation

0 Participants

SECONDARY outcome

Timeframe: Enrollment, day 28

WHO COVID-19, "8-point ordinal scale" has a range of 1-8 with higher numbers indicating a more severe disease.

Outcome measures

Measure	Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.
Change in the World Health Organization (WHO) COVID-19, "8-point Ordinal Scale" as Shown by Presenting Selected Time Points Through Day 28 Day 1	4.67 score on a scale Standard Deviation 0.42
Change in the World Health Organization (WHO) COVID-19, "8-point Ordinal Scale" as Shown by Presenting Selected Time Points Through Day 28 Day 3	2.8 score on a scale Standard Deviation 0.74
Change in the World Health Organization (WHO) COVID-19, "8-point Ordinal Scale" as Shown by Presenting Selected Time Points Through Day 28 Day 15	1.17 score on a scale Standard Deviation 0.16
Change in the World Health Organization (WHO) COVID-19, "8-point Ordinal Scale" as Shown by Presenting Selected Time Points Through Day 28 Day 28	1.20 score on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: Up to 28 days

Duration of hospitalization - number of inpatient hospital days. Participants were planned to be followed for up to 28 days, although the longest actual hospital stay for a participant was 10 days.

Outcome measures

Measure

Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.

Actual Duration of Hospitalization

4.67 days Standard Deviation 2.56

SECONDARY outcome

Timeframe: Up to 28 days

Duration of ICU stay - number of ICU days. Participants were planned to be followed for up to 28 days, although the longest actual hospital stay for a participant was 10 days.

Outcome measures

Measure

Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.

Actual Duration of ICU Care

1.33 days Standard Deviation 1.89

SECONDARY outcome

Timeframe: Up to 28 days

Number of participants who experienced a Grade 3 or Grade 4 hemorrhagic event based on the World Health Organization's (WHO) Bleeding Scale. On the scale, a Grade 3 event means gross blood loss, and a Grade 4 event means debilitating blood loss.

Outcome measures

Measure

Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.

Participants Who Experienced Grade 3-4 Hemorrhagic Events

0 Participants

SECONDARY outcome

Timeframe: 6 Days

Changes in E-selectin plasma concentrations measured each day for 6 days.

Outcome measures

Measure	Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.
Change in E-selectin Plasma Concentrations, as Shown by Values for Each of Those Days Day 1	19.19 Nanograms divided by milliliter Standard Deviation 9.783
Change in E-selectin Plasma Concentrations, as Shown by Values for Each of Those Days Day 2	15.15 Nanograms divided by milliliter Standard Deviation 6.524
Change in E-selectin Plasma Concentrations, as Shown by Values for Each of Those Days Day 3	18.15 Nanograms divided by milliliter Standard Deviation 9.660
Change in E-selectin Plasma Concentrations, as Shown by Values for Each of Those Days Day 4	18.09 Nanograms divided by milliliter Standard Deviation 7.239
Change in E-selectin Plasma Concentrations, as Shown by Values for Each of Those Days Day 5	27.04 Nanograms divided by milliliter Standard Deviation 0.000
Change in E-selectin Plasma Concentrations, as Shown by Values for Each of Those Days Day 6	26.85 Nanograms divided by milliliter Standard Deviation 0.000

SECONDARY outcome

Timeframe: Enrollment, up to day 28

Venous thromboembolism - DVT or PE

Outcome measures

Measure

Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.

Participants Who Experienced Venous Thromboembolism (Deep Venous Thrombosis or Pulmonary Embolism)

0 Participants

SECONDARY outcome

Timeframe: Up to Day 28

Days of mechanical ventilation and days of vasopressors

Outcome measures

Measure	Uproleselan n=6 Participants Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.
Number of Mechanical Ventilation and Vasopressor Days Days of mechanical ventilation	0 days
Number of Mechanical Ventilation and Vasopressor Days vasopressor days	0 days

Adverse Events

Uproleselan

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Uproleselan n=6 participants at risk Uproleselan injection is a sterile solution for IV administration, supplied in single-dose vials at a concentration of 50 mg/mL. Uproleselan: 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.
Blood and lymphatic system disorders bilateral leg edema	16.7% 1/6 • 28 days
Ear and labyrinth disorders dizziness	16.7% 1/6 • 28 days
Gastrointestinal disorders mild diarrhea and indigestion	16.7% 1/6 • 28 days
Blood and lymphatic system disorders bruising from clinical blood draws	16.7% 1/6 • 28 days

Additional Information

Lena M. Napolitano MD

University of Michigan

Phone: 734-615-4775

Email: lenan@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60