This study examines the efficacy of N-acetylglucosamine (NAG) in treating patients with novel coronavirus (COVID-19) infection.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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.
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.
Valley Baptist Medical Center
Harlingen, Texas, United States
Number of Participants Intubated During Hospitalization
The occurrence of intubation during hospitalization.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days and maximum of 30 days.
Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization
The occurrence of intensive care unit (ICU) admission.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.