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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-14

Study Completion Date

2021-01-15

Brief Summary

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

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Detailed Description

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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).

Conditions

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Coronavirus Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

N-acetyl glucosamine (NAG)

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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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.