Phase II Study of N-acetylcysteine in Severe or Critically Ill Patients With Refractory COVID-19 Infection
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Arm A: number of patients who are successfully extubated and/or transferred out of critical care due to clinical improvement
研究概览
简要总结
The study researchers think that a medication called N-acetylcysteine can help fight the COVID-19 virus by boosting a type of cell in your immune system that attacks infections. By helping your immune system fight the virus, the researchers think that the infection will get better, which could allow the patient to be moved out of the critical care unit or go off a ventilator, or prevent them from moving into a critical care unit or going on a ventilator.
The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat the liver side effects resulting from an overdose of the anti-inflammatory medication Tylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD). This study is the first to test N-acetylcysteine in people with severe COVID-19 infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented COVID-19 infection (either performed on site or documented external report)
- •Admission to an intensive care unit at MSK (M-11) and/or receiving mechanical ventilation
- •Absolute lymphocyte count ≤ 1.0/mm3
- •As the ALC of patients with lymphoid malignancies is unreliable, they may be enrolled at the discretion of the treating physician after review of their blood work.
- •Arm B:Requiring 2L or more of supplemental oxygen by nasal cannula or higher to maintain SpO2 of 95%
排除标准
- •requiring mechanical ventilation or admission to an intensive care unit at MSK (M11)
研究组 & 干预措施
mechanically ventilated &/or managed in a critical-care
This arm is closed to accrual as of September 2020. Patients in both arms will receive N-acetylcysteine IV 6 g/day in addition to supportive and/or COVID-19 directed treatments at the discretion of the treating physician.
Patients will receive treatment for a maximum of 3 weeks or until one of the following:
Arm A:
- Transfer out of the critical-care unit
- Extubation
- Toxicity
- Death
干预措施: Peripheral Blood (Other)
non-mechanically ventilated, non-critical-care
Patients in both arms will receive N-acetylcysteine IV 6 g/day in addition to supportive and/or COVID-19 directed treatments at the discretion of the treating physician.
Patients will receive treatment for a maximum of 3 weeks or until one of the following:
Arm B:
- Discharge from hospital
- Admission to a critical-care unit
- Intubation
- Toxicity
- Death
干预措施: Peripheral Blood (Other)
non-mechanically ventilated, non-critical-care
Patients in both arms will receive N-acetylcysteine IV 6 g/day in addition to supportive and/or COVID-19 directed treatments at the discretion of the treating physician.
Patients will receive treatment for a maximum of 3 weeks or until one of the following:
Arm B:
- Discharge from hospital
- Admission to a critical-care unit
- Intubation
- Toxicity
- Death
干预措施: N-acetylcysteine (Drug)
mechanically ventilated &/or managed in a critical-care
This arm is closed to accrual as of September 2020. Patients in both arms will receive N-acetylcysteine IV 6 g/day in addition to supportive and/or COVID-19 directed treatments at the discretion of the treating physician.
Patients will receive treatment for a maximum of 3 weeks or until one of the following:
Arm A:
- Transfer out of the critical-care unit
- Extubation
- Toxicity
- Death
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Arm A: number of patients who are successfully extubated and/or transferred out of critical care due to clinical improvement
时间窗: 1 year
Arm B: number of patients who are discharged from the hospital due to clinical improvement
时间窗: 1 year
次要结局
未报告次要终点