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

Phase 1

Completed

• Conditions: Covid19; Coronavirus
• Interventions: Other: Control; Dietary Supplement: N-acetyl glucosamine (NAG)

• Registration Number: NCT04706416
• Lead Sponsor: Quantinosis.ai LLC

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).

Study Timeline

• Study Start: 2020-11-14
• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-12
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Results First Submitted: 2021-10-27
• Results First Submitted QC: 2021-11-02
• Results First Posted: 2021-11-04
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-02
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	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.
N-Acetyl Glucosamine	N-acetyl glucosamine (NAG)	All patients in the treatment arm of the study were treated with N-Acetyl Glucosamine, a potential therapy for Coronavirus Disease-19 (COVID-19).

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Died During Hospitalization	Through study completion (duration of patient's hospitalization), an average of 7-10 days.	The occurrence of death during hospitalization.
Hospital Length of Stay (LOS)	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.
Number of Participants Intubated During Hospitalization	Through study completion (duration of patient's hospitalization), an average of 7-10 days.	The occurrence of intubation during hospitalization.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization	Through study completion (duration of patient's hospitalization), an average of 7-10 days.	The occurrence of intensive care unit (ICU) admission.
ICU Length of Stay	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.
Supplemental Oxygen Duration	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.
Number of Participants Who Experienced Hospice Initiation During Hospitalization	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.
Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization	Through study completion (duration of patient's hospitalization), an average of 7-10 days.	The occurrence of either death or initiation of hospice proceedings.

Trial Locations

Locations (1)

Valley Baptist Medical Center; 🇺🇸 Harlingen, Texas, United States