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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706416
• Other study ID #: IRB #2020-106
• Status: Completed
• Phase: Phase 1
• Start date: November 14, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: April 2023
• Source: Quantinosis.ai LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID-19
• Covid19

Intervention

Dietary Supplement:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Valley Baptist Medical Center	Harlingen	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Quantinosis.ai LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.