N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of Participants Who Died During Hospitalization
研究概览
简要总结
This study examines the efficacy of N-acetylglucosamine (NAG) in treating patients with novel coronavirus (COVID-19) infection.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •<18 years old upon admission
- •Allergy to NAG
- •Allergy to shellfish
- •Currently taking warfarin
- •Currently pregnant or lactating
结局指标
主要结局
Number of Participants Who Died During Hospitalization
时间窗: 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)
时间窗: 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
时间窗: Through study completion (duration of patient's hospitalization), an average of 7-10 days.
The occurrence of intubation during hospitalization.
次要结局
- 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.)
- ICU Length of Stay(Through study completion (duration of patient's hospitalization), an average of 7-10 days and a maximum of 30 days.)
- Supplemental Oxygen Duration(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(Through study completion (duration of patient's hospitalization), an average of 7-10 days.)
- Number of Participants Who Experienced Poor Clinical Outcome During Hospitalization(Through study completion (duration of patient's hospitalization), an average of 7-10 days.)