NCT05057221

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

Terminated Phase 1, PHASE2 Results posted Last updated 10 July 2023

What this trial tests

Phase 1, PHASE2 trial testing Uproleselan in COVID-19 Pneumonia in 6 participants. Terminated before completion.

Timeline

12 November 2021

Primary endpoint
9 March 2022

9 March 2022

Quick facts

Lead sponsor	Lena Napolitano, MD
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	12 November 2021
Primary completion	9 March 2022
Estimated completion	9 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Uproleselan — full drug profile →

Conditions studied

• COVID-19 Pneumonia — all drugs for COVID-19 Pneumonia →

Sponsor

Lena Napolitano, MD

Who can join

Adults 18 to 75, any sex, with COVID-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety of Uproleselan - as Measured by Serious Adverse Events Primary · Up to 28 days

Descriptive statistics will be calculated for quantitative safety data

Group	Value	95% CI
Uproleselan	0

Safety of Uproleselan- as Measured by Frequency of Serious Adverse Events Primary · Up to 28 days

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

Group	Value	95% CI
Uproleselan	0

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

Group	Value	95% CI
Uproleselan	0

Number of Patients Alive Who Are Free of Respiratory Failure Secondary · Up to 28 days

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

Group	Value	95% CI
Uproleselan	6

All-cause Mortality Secondary · Up to 28 days

All-cause hospital mortality

Group	Value	95% CI
Uproleselan	0

Time to Change Oxygenation Secondary · during hospitalization; hospital stay ranged from 2 to 10 days

Number of days it took to reduce their oxygen requirements

Group	Value	95% CI
Uproleselan	2	± 1

Number of Patients Requiring Mechanical Ventilation Secondary · Up to 28 days

Number of patients requiring mechanical ventilation

Group	Value	95% CI
Uproleselan	0

Change in the World Health Organization (WHO) COVID-19, "8-point Ordinal Scale" as Shown by Presenting Selected Time Points Through Day 28 Secondary · Enrollment, day 28

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

Day 1

Group	Value	95% CI
Uproleselan	4.67	± 0.42

Day 3

Group	Value	95% CI
Uproleselan	2.8	± 0.74

Day 15

Group	Value	95% CI
Uproleselan	1.17	± 0.16

Day 28

Group	Value	95% CI
Uproleselan	1.20	± 0.2

Actual Duration of Hospitalization Secondary · 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.

Group	Value	95% CI
Uproleselan	4.67	± 2.56

Actual Duration of ICU Care Secondary · 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.

Group	Value	95% CI
Uproleselan	1.33	± 1.89

Participants Who Experienced Grade 3-4 Hemorrhagic Events Secondary · 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.

Group	Value	95% CI
Uproleselan	0

Change in E-selectin Plasma Concentrations, as Shown by Values for Each of Those Days Secondary · 6 Days

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

Day 1

Group	Value	95% CI
Uproleselan	19.19	± 9.783

Day 2

Group	Value	95% CI
Uproleselan	15.15	± 6.524

Day 3

Group	Value	95% CI
Uproleselan	18.15	± 9.660

Day 4

Group	Value	95% CI
Uproleselan	18.09	± 7.239

Day 5

Group	Value	95% CI
Uproleselan	27.04	± 0.000

Day 6

Group	Value	95% CI
Uproleselan	26.85	± 0.000

Adverse events — posted to ClinicalTrials.gov

Time frame: 28 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Uproleselan

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (4 terms — click to expand)

Reaction	System	Uproleselan
bilateral leg edema	Blood and lymphatic system disorders	—
dizziness	Ear and labyrinth disorders	—
mild diarrhea and indigestion	Gastrointestinal disorders	—
bruising from clinical blood draws	Blood and lymphatic system disorders	—

Data from ClinicalTrials.gov NCT05057221 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Glycomimetics for the inhibition and modulation of lectins.
   Leusmann S, Ménová P, Shanin E, Titz A, et al · · 2023 · cited 73× · PMID 37232696 · DOI 10.1039/d2cs00954d
2. P- and E- selectin in venous thrombosis and non-venous pathologies.
   Purdy M, Obi A, Myers D, Wakefield T. · · 2022 · cited 60× · PMID 35243742 · DOI 10.1111/jth.15689
3. Learning through a Pandemic: The Current State of Knowledge on COVID-19 and Cancer.
   Elkrief A, Wu JT, Jani C, Enriquez KT, et al · · 2022 · cited 33× · PMID 34893494 · DOI 10.1158/2159-8290.cd-21-1368