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

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

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).

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

Conditions
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Coronavirus, Covid19

Intervention / Treatment
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* Dietary Supplement: N-acetyl glucosamine (NAG)
* Other: Control


Participation Criteria
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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. Exclusion Criteria: <18 years old upon admission Allergy to NAG Allergy to shellfish Currently taking warfarin Currently pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N-Acetyl Glucosamine<br>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)<br>* 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.<br>|
| Placebo Comparator: Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization | 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 | 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 | 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 | 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 | The occurrence of either death or initiation of hospice proceedings. | Through study completion (duration of patient's hospitalization), an average of 7-10 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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N-acetyl glucosamine