N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)

NCT04706416 | Completed Phase 1 Results

• 1 other identifier: IRB #2020-106
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the efficacy of N-acetylglucosamine (NAG) in treating patients with novel coronavirus (COVID-19) infection.

Conditions

Coronavirus; Covid19

Keywords

N-acetyl glucosamine

Outcome Measures

Primary Outcomes (3)

• Number of Participants Intubated During Hospitalization

  The occurrence of intubation during hospitalization.

  Through study completion (duration of patient's hospitalization), an average of 7-10 days.

• Number of Participants Who Died During Hospitalization

  The occurrence of death during hospitalization.

  Through study completion (duration of patient's hospitalization), an average of 7-10 days.

• Hospital Length of Stay (LOS)

  The number of days the patient is hospitalized.

  Through study completion (duration of patient's hospitalization), an average of 7-10 days and maximum of 30 days.

Secondary Outcomes (5)

• Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization

  Through study completion (duration of patient's hospitalization), an average of 7-10 days.

• ICU Length of Stay

  Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.

• Supplemental Oxygen Duration

  Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.

• Number of Participants Who Experienced Hospice Initiation During Hospitalization

  Through study completion (duration of patient's hospitalization), an average of 7-10 days.

• Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization

  Through study completion (duration of patient's hospitalization), an average of 7-10 days.

Study Arms (2)

N-Acetyl Glucosamine

EXPERIMENTAL

All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).

Dietary Supplement: N-acetyl glucosamine (NAG)

Control

PLACEBO COMPARATOR

All patients in the comparator arm were admitted to the same hospital with COVID-19 but did not receive N-Acetyl Glucosamine treatment. All these patients were identified retrospectively.

Other: Control

Interventions

N-acetyl glucosamine (NAG) DIETARY_SUPPLEMENT

Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.

N-Acetyl Glucosamine

Control OTHER

Patients do not receive treatment with N-Acetylglucosamine. They may receive other treatments at the discretion of the treating physician, as with the treatment group.

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old
• Treated with N-acetyl glucosamine (NAG) as first-line treatment
• Present with coronavirus disease 2019 (COVID-19) symptoms (including but not limited to fever, cough, shortness of breath, sore throat, nasal congestion, malaise, headache, muscle pain, loss of taste and/or smell, diarrhea, and vomiting)
• Clinically diagnosed with COVID-19 by reverse transcription polymerase chain reaction (RT-PCR)
• No intubation prior to hospitalization and enrollment in the current study.

You may not qualify if:

• \<18 years old upon admission
• Allergy to NAG
• Allergy to shellfish
• Currently taking warfarin
• Currently pregnant or lactating

Sponsors & Collaborators

• Quantinosis.ai LLC: lead

Study Sites (1)

Valley Baptist Medical Center

Harlingen, Texas, 78550, United States

Location

Related Publications (1)

• Hassan AE. An observational cohort study to assess N-acetylglucosamine for COVID-19 treatment in the inpatient setting. Ann Med Surg (Lond). 2021 Aug;68:102574. doi: 10.1016/j.amsu.2021.102574. Epub 2021 Jul 16.

  PMID: 34306677 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

Acetylglucosamine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glucosamine; Hexosamines; Amino Sugars; Carbohydrates

Limitations and Caveats

The conclusions that can be drawn from this study are limited by the relatively small number of participants, lack of randomization, use of a retrospective control arm, use of consecutive patients, temporality of different study arms in different stages of the pandemic, taking place at a single center, concomitant therapies, and potentially confounding baseline variables. These limitations were considered necessary costs in order to rapidly provide information during the COVID-19 pandemic.

Results Point of Contact

• Title: Dr. Ameer Hassan
• Organization: Valley Baptist Medical Center

ameerehassan@gmail.com

973-303-8146

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 12, 2021
• Study Start: November 14, 2020
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: April 4, 2023
• Results First Posted: November 4, 2021

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)