Trial · NCT05057221
Safety, Tolerability and Efficacy of Uproleselan (GMI-1271) in Patients With COVID-19 Pneumonia
NCT05057221, Phase 1, Phase 2, Terminated, Lena Napolitano, MD; results first posted 2023-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Tolerability and Efficacy of Uproleselan (GMI-1271) in Patients With COVID-19 Pneumonia. Trials, record NCT05057221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05057221
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability and Efficacy of Uproleselan (GMI-1271) in Patients With COVID-19 Pneumonia
- NCT number
- NCT05057221
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Lena Napolitano, MD
- Conditions
- COVID-19 Pneumonia
- Interventions
- Uproleselan
- First posted
- 2021-09-27
- Last updated
- 2023-07-10
- Results first posted
- 2023-07-10
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of Uproleselan - as Measured by Serious Adverse Events | Up to 28 days | Descriptive statistics will be calculated for quantitative safety data |
| Primary | Safety of Uproleselan- as Measured by Frequency of Serious Adverse Events | Up to 28 days | Frequency counts will be compiled for classification of qualitative safety data. |
| Secondary | Change in the Progression to Acute Respiratory Failure for Patients With a Baseline PaO2/FiO2 >= 200 | 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. |
| Secondary | Number of Patients Alive Who Are Free of Respiratory Failure | Up to 28 days | Number of patients alive and free of acute respiratory failure which required initiation of mechanical ventilation |
| Secondary | All-cause Mortality | Up to 28 days | All-cause hospital mortality |
| Secondary | Time to Change Oxygenation | during hospitalization; hospital stay ranged from 2 to 10 days | Number of days it took to reduce their oxygen requirements |
| Secondary | Number of Patients Requiring Mechanical Ventilation | Up to 28 days | Number of patients requiring mechanical ventilation |
| Secondary | Change in the World Health Organization (WHO) COVID-19, "8-point Ordinal Scale" as Shown by Presenting Selected Time Points Through Day 28 | Enrollment, day 28 | WHO COVID-19, "8-point ordinal scale" has a range of 1-8 with higher numbers indicating a more severe disease. |
| Secondary | Actual Duration of Hospitalization | 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. |
| Secondary | Actual Duration of ICU Care | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety of Uproleselan - as Measured by Serious Adverse Events | Up to 28 days | Serious Adverse Events | NUMBER | |
| PRIMARY | Safety of Uproleselan- as Measured by Frequency of Serious Adverse Events | Up to 28 days | daily events | NUMBER | |
| SECONDARY | Change in the Progression to Acute Respiratory Failure for Patients With a Baseline PaO2/FiO2 >= 200 | Enrollment, 15 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Alive Who Are Free of Respiratory Failure | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | All-cause Mortality | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Change Oxygenation | during hospitalization; hospital stay ranged from 2 to 10 days | Days | MEAN | |
| SECONDARY | Number of Patients Requiring Mechanical Ventilation | Up to 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in the World Health Organization (WHO) COVID-19, 8-point Ordinal Scale as Shown by Presenting Selected Time Points Through Day 28 | Enrollment, day 28 | score on a scale | MEAN | |
| SECONDARY | Actual Duration of Hospitalization | Up to 28 days | days | MEAN | |
| SECONDARY | Actual Duration of ICU Care | Up to 28 days | days | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety of Uproleselan - as Measured by Serious Adverse Events | Uproleselan | 0 | Serious Adverse Events | ||
| Safety of Uproleselan- as Measured by Frequency of Serious Adverse Events | Uproleselan | 0 | daily events | ||
| Change in the Progression to Acute Respiratory Failure for Patients With a Baseline PaO2/FiO2 >= 200 | Uproleselan | 0 | Participants | ||
| Number of Patients Alive Who Are Free of Respiratory Failure | Uproleselan | 6 | Participants | ||
| All-cause Mortality | Uproleselan | 0 | Participants | ||
| Time to Change Oxygenation | Uproleselan | 2 | Standard Deviation 1 | Days | |
| Number of Patients Requiring Mechanical Ventilation | Uproleselan | 0 | Participants | ||
| Change in the World Health Organization (WHO) COVID-19, 8-point Ordinal Scale as Shown by Presenting Selected Time Points Through Day 28 | Uproleselan | Day 1 | 4.67 | Standard Deviation 0.42 | score on a scale |
| Change in the World Health Organization (WHO) COVID-19, 8-point Ordinal Scale as Shown by Presenting Selected Time Points Through Day 28 | Uproleselan | Day 3 | 2.8 | Standard Deviation 0.74 | score on a scale |
| Change in the World Health Organization (WHO) COVID-19, 8-point Ordinal Scale as Shown by Presenting Selected Time Points Through Day 28 | Uproleselan | Day 15 | 1.17 | Standard Deviation 0.16 | score on a scale |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Uproleselan | 6 | |
| Overall Study | COMPLETED | Uproleselan | 6 | |
| Overall Study | NOT COMPLETED | Uproleselan | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | bilateral leg edema | Blood and lymphatic system disorders | Uproleselan | 1 | 6 | |
| other | dizziness | Ear and labyrinth disorders | Uproleselan | 1 | 6 | |
| other | mild diarrhea and indigestion | Gastrointestinal disorders | Uproleselan | 1 | 6 | |
| other | bruising from clinical blood draws | Blood and lymphatic system disorders | Uproleselan | 1 | 6 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Uproleselan | 0 | 6 |
| Total, other adverse events | Uproleselan | 3 | 6 |
| Total, serious adverse events | Uproleselan | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05057221
GET https://conductscience.org/api/trials/v1/NCT05057221/results?page=2