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E-Selectin Antagonist

Uproleselan for Coronavirus Pneumonia

Phase 1 & 2

Waitlist Available

Research Sponsored by Lena Napolitano, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during hospitalization; hospital stay ranged from 2 to 10 days

Awards & highlights

Study Summary

This trial will test if the drug uproleselan can help people with severe COVID-19 pneumonia recover more quickly and slow down the progression of acute respiratory failure.

Eligible Conditions

Coronavirus Pneumonia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during hospitalization; hospital stay ranged from 2 to 10 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during hospitalization; hospital stay ranged from 2 to 10 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and during hospitalization; hospital stay ranged from 2 to 10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of Uproleselan - as Measured by Serious Adverse Events

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

Secondary outcome measures

Actual Duration of Hospitalization

Actual Duration of ICU Care

All-cause Mortality

+9 more

Side effects data

From 2022 Phase 2 trial • 51 Patients • NCT04682405

100%

White blood cell decreased

100%

Neutrophil count decreased

100%

Hypocalcemia

100%

Diarrhea

100%

Platelet count decreased

96%

Anemia

96%

Nausea

92%

Lymphocyte count decreased

88%

Fatigue

88%

Hypoalbuminemia

81%

Abdominal Pain

81%

Hypophosphatemia

81%

INR increased

69%

Hypokalemia

65%

Vomiting

50%

Esophageal Pain

50%

Mucositis oral

38%

Esophagitis

35%

Enterocolitis

35%

Constipation

35%

Fever

35%

Malaise

31%

Hyponatremia

31%

Hypotension

27%

Thrush

23%

Gastritis

23%

Dizziness

19%

Back Pain

19%

Hemorrhoids

15%

Proctitis

15%

Edema Limbs

15%

Anorexia

12%

Infections and Infestations - other

12%

Enterocolitis Infectious

12%

Alanine aminotransferase increased

12%

Blood bilirubin increased

12%

Musculoskeletal and Connective Tissue Disorder - other

12%

Gastroesophageal Reflux Disease

12%

Eye Disorders - other

12%

Dehydration

12%

Hyperglycemia

12%

Activated partial thromboplastin time prolonged

12%

Skin Infection

Wheezing

Anxiety

Pain in Extremity

Hyperphosphatemia

Periorbital Edema

Hypoglycemia

Generalized Muscle Weakness

Peripheral Sensory Neuropathy

Bruising

Dyspnea

Skin and Subcutaneous Tissue Disorders - other

Febrile neutropenia

Creatinine increased

Bloating

Flatulence

Headache

Hypernatremia

Aspartate aminotransferase increased

Infusion Site Extravasation

Adrenal Insufficiency

Respiratory, Thoracic, and Mediastinal Disorders - other

Facial Pain

Vision Decreased

Nervous System Disorders - other

Dysphagia

Hyperkalemia

Lethargy

Insomnia

Allergic Rhinitis

Chills

Localized Edema

Bacteremia

Sepsis

Urinary Tract Infection

Muscle Cramp

Restlessness

Hematuria

Testicular Pain

Cough

Hypertension

Lung Infection

Papulopustular Rash

Neoplasms benign, malignant, and unspecified (incl cysts and polyps) - other

Psychiatric Disorders - other

Delirium

Sinus Tachycardia

Encephalopathy

Dysuria

Toothache

Sinusitis

Dry Mouth

Fall

Pulmonary Edema

Non-cardiac Chest Pain

Alkaline phosphatase increased

Nasal Congestion

Otitis Externa

Extraocular Muscle Paresis

Blurred Vision

Generalized Edema

Confusion

Hallucinations

100%

80%

60%

40%

20%

Study treatment Arm

Uproleselan + Standard of Care Melphalan

Placebo + Standard of Care Melphalan

Trial Design

1Treatment groups

Experimental Treatment

Group I: UproleselanExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Uproleselan

2018

Completed Phase 2

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lena Napolitano, MDLead Sponsor

GlycoMimetics IncorporatedIndustry Sponsor

22 Previous Clinical Trials

1,506 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

If a septuagenarian meets the other requirements, are they able to participate in this research?

"As long as they are between 18-75 years old, patients of any age are eligible for this clinical trial."

Answered by AI

Is this study open to new participants?

"That is accurate, the website clinicaltrials.gov has listed this trial as currently recruiting patients. This trial was posted on November 12th, 2021 and was last edited on December 6th, 2021. The study is looking for 15 patients at a single location."

Answered by AI

Could you please share any other instance in which Uproleselan has been tested in a clinical setting?

"There are currently six clinical trials underway for Uproleselan. Two of those are in the final stage, Phase 3. The majority of research locations for Uproleselan are in Houston, Texas, but there are 77 total sites running trials for this new treatment."

Answered by AI

Has a study like this one ever been done before?

"There have been a total of 6 studies investigating Uproleselan since 2018, with the most recent ones having completed their Phase 3 drug approval stages. These studies, which have taken place across 41 cities and 10 countries, have involved 388 andSponsored by GlycoMimetics Incorporated."

Answered by AI

Who is this clinical trial designed for?

"15 individuals who have pneumonia and meet the age criteria of 18 to 75 years old are needed for this clinical study. Furthermore, these patients must also require supplemental oxygen and be willing to participate in all required evaluations and procedures."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Lena Napolitano, MD 2021. "Safety, Tolerability and Efficacy of Uproleselan (GMI-1271) in Patients With COVID-19 Pneumonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05057221.