A Study of N-acetylcysteine in Patients With COVID-19 Infection
- Conditions
- Covid-19
- Interventions
- Other: Peripheral Blood
- Registration Number
- NCT04374461
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 48
- Documented COVID-19 infection (either performed on site or documented external report)
- Age ≥ 18
Arm A:
- 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:
- Arm B:Requiring 2L or more of supplemental oxygen by nasal cannula or higher to maintain SpO2 of 95%
Arm B:
- requiring mechanical ventilation or admission to an intensive care unit at MSK (M11)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mechanically ventilated &/or managed in a critical-care Peripheral Blood 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 non-mechanically ventilated, non-critical-care Peripheral Blood 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 non-mechanically ventilated, non-critical-care N-acetylcysteine 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 mechanically ventilated &/or managed in a critical-care N-acetylcysteine 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
- Primary Outcome Measures
Name Time Method Arm A: number of patients who are successfully extubated and/or transferred out of critical care due to clinical improvement 1 year Arm B: number of patients who are discharged from the hospital due to clinical improvement 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States