Clinical trial NCT04706416: N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)
Official title: N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronavirus
Covid19
Keywords: N-acetyl glucosamine
Lead sponsor: Quantinosis.ai LLC
Sponsor class: INDUSTRY
First posted: 2021-01-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Intubated During Hospitalization
timeFrame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
measure: Number of Participants Who Died During Hospitalization
timeFrame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
measure: Hospital Length of Stay (LOS)
timeFrame: Through study completion (duration of patient's hospitalization), an average of 7-10 days and maximum of 30 days.
Secondary outcomes:
measure: Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization
timeFrame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
measure: ICU Length of Stay
timeFrame: Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.
measure: Supplemental Oxygen Duration
timeFrame: Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.
measure: Number of Participants Who Experienced Hospice Initiation During Hospitalization
timeFrame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
measure: Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization
timeFrame: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
Other outcomes:
Locations:
city: Harlingen
country: United States
facility: Valley Baptist Medical Center
state: Texas
Study officials:
References:
citation: 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.