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

April 2, 2023 updated by: Quantinosis.ai LLC
This study examines the efficacy of N-acetylglucosamine (NAG) in treating patients with novel coronavirus (COVID-19) infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single center, prospective, observational cohort study. A total of 150 cases who test positive for the novel coronavirus (COVID-19) will be recruited. Presenting to the emergency room of the study site, these cases will be treated with N-acetylglucosamine (NAG) in 700 mg doses every 12 hours as first-line treatment for 30 days. Standard of care (e.g., remdesivir approved for emergency use in severe cases, ventilator for patients with respiratory failure, etc.) will be provided based on the patient's clinical needs, which will be at the discretion of the treating physician. Upon admission, the research team will record patient demographics, comorbidities, symptoms, disease severity (as assessed by the World Health Organization Ordinal Scale for Clinical Improvement), need for supplemental oxygen, and time from symptom onset until hospital arrival. The research team will also collect bloodwork for the following at admission: white blood cell count (WBC), hematocrit (HCT), hemoglobin (HBG), C-reactive protein (CRP), procalcitonin (PCT), interleukin-6 (IL-6), and erythrocyte sedimentation rate (ESR). During the study period, discretionary treatments and interventions will be recorded daily until study exit. The primary outcomes of interest are rate of intubation, hospital length of stay, and mortality. Secondary outcomes of interest include intensive care unit (ICU) admission, ICU length of stay (LOS), supplemental oxygen duration, rate of hospice initiation, and poor clinical outcome (defined as combined death/hospice initiation).

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Harlingen, Texas, United States, 78550
        • Valley Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N-Acetyl Glucosamine
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)
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.
Placebo Comparator: Control
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Intubated During Hospitalization
Time Frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
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
Time Frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
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)
Time Frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days and maximum of 30 days.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization
Time Frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
The occurrence of intensive care unit (ICU) admission.
Through study completion (duration of patient's hospitalization), an average of 7-10 days.
ICU Length of Stay
Time Frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.
The number of days the patient is in the ICU.
Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.
Supplemental Oxygen Duration
Time Frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.
The duration of supplemental oxygen use.
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
Time Frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
The occurrence of hospice proceedings initiation, indicating irreversible and imminent decline in health.
Through study completion (duration of patient's hospitalization), an average of 7-10 days.
Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization
Time Frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
The occurrence of either death or initiation of hospice proceedings.
Through study completion (duration of patient's hospitalization), an average of 7-10 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quantinosis.ai LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2020

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

December 31, 2020

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #2020-106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will publish based on summary data, but make individual participant data available upon request. There are no plans to publish individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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