N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- Coronavirus
- COVID-19
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention 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)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a single center, prospective, observational cohort study. A total of 50 cases who are novel coronavirus (COVID-19) positive will be recruited. Presenting to the emergency room of the study site, these cases will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line ...
This is a single center, prospective, observational cohort study. A total of 50 cases who are novel coronavirus (COVID-19) positive will be recruited. Presenting to the emergency room of the study site, these cases will be treated with N-acetylglucosamine (NAG) (700 mg 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. The results of the patient's blood work (e.g. complete blood count, C-reactive protein [CRP], procalcitonin [PCT], IL-6, erythrocyte sedimentation rate [ESR], etc.), symptom progression, clinical severity, and outcomes will be collected on a daily basis during hospitalization until. The primary outcomes of interest are rates of intubation, mortality, and length of stay (LOS) following rapid administration of 700 mg NAG for COVID-19-related symptoms. Secondary outcomes of interest include: change in COVID-19 disease severity as assessed by the WHO Ordinal Scale for Clinical Improvement; symptom duration; ICU admission; supplemental oxygen use and duration; and change in inflammatory biomarker levels (CRP, PCT, IL-6, ESR). Finally, the safety profile of NAG was evaluated using patient medical records from Day 1 through discharge.
Tracking Information
- NCT #
- NCT04706416
- Collaborators
- Not Provided
- Investigators
- Not Provided