A Study of N-acetylcysteine in Patients With COVID-19 Infection (NCT04374461) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of N-acetylcysteine in Patients With COVID-19 Infection
United States48 participantsStarted 2020-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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%
Exclusion Criteria:
Arm B:
* requiring mechanical ventilation or admission to an intensive care unit at MSK (M11)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Arm A: number of patients who are successfully extubated and/or transferred out of critical care due to clinical improvement
Timeframe: 1 year
2
Arm B: number of patients who are discharged from the hospital due to clinical improvement