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Mucolytic Agent

N-acetylcysteine for COVID-19

Phase 2
Waitlist Available
Led By Santosha Vardhana, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18
Requiring 2L or more of supplemental oxygen by nasal cannula or higher to maintain SpO2 of 95%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether or not N-acetylcysteine can help fight the COVID-19 virus by boosting a type of cell in your immune system.

Who is the study for?
This trial is for adults over 18 with COVID-19 needing oxygen support to maintain good blood oxygen levels. They must be in intensive care or on a ventilator at MSK (M-11) and have low counts of certain immune cells. People already on mechanical ventilation or admitted to ICU at MSK (M11) can't join.Check my eligibility
What is being tested?
Researchers are testing N-acetylcysteine, which may boost the immune system's ability to fight COVID-19, potentially improving patient outcomes like reducing time in critical care or need for a ventilator. This is its first test against severe COVID-19 infections.See study design
What are the potential side effects?
N-acetylcysteine might cause side effects such as allergic reactions, respiratory symptoms, gastrointestinal disturbances, and fatigue; however, it's generally considered safe based on its use for other conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I need extra oxygen to keep my oxygen levels normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Arm A: number of patients who are successfully extubated and/or transferred out of critical care due to clinical improvement
Arm B: number of patients who are discharged from the hospital due to clinical improvement

Trial Design

2Treatment groups
Experimental Treatment
Group I: non-mechanically ventilated, non-critical-careExperimental Treatment2 Interventions
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
Group II: mechanically ventilated &/or managed in a critical-careExperimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylcysteine
FDA approved

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,760 Total Patients Enrolled
Santosha Vardhana, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

N-acetylcysteine (Mucolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04374461 — Phase 2
Coronavirus Research Study Groups: mechanically ventilated &/or managed in a critical-care, non-mechanically ventilated, non-critical-care
Coronavirus Clinical Trial 2023: N-acetylcysteine Highlights & Side Effects. Trial Name: NCT04374461 — Phase 2
N-acetylcysteine (Mucolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04374461 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any fresh participants being sought for the trial?

"The trial data found on clinicaltrials.gov indicates that at the present time, this particular medical investigation is not looking for participants; while it was initially posted in May of 2020 and most recently updated in July 2022, recruitment has now ceased. Nonetheless, there are still 1755 separate research projects actively searching for volunteers to participate."

Answered by AI

Are there any additional experiments involving N-acetylcysteine that have been conducted?

"At present, 38 clinical trials are underway for N-acetylcysteine. These can be broken down into 7 Phase 3 trials and many more research locations (44 in total) which primarily reside in New york City."

Answered by AI

What therapeutic applications does N-acetylcysteine have?

"N-acetylcysteine is an effective solution for corneal ulceration and can additionally be deployed to abate acute rhinitis, acetaminophen toxicity, as well as a handful of other ocular pathologies."

Answered by AI

Has the Food and Drug Administration given its stamp of approval to N-acetylcysteine?

"Our team believes that N-acetylcysteine's safety is rated a 2, as there has been preliminary research done to affirm its security but no trials have established its efficacy."

Answered by AI

How many individuals are participating in this scientific trial?

"Unfortunately, enrollment for this medical trial has concluded. First posted on May 1st 2020 and last updated July 22nd 2022, the study is no longer seeking participants. However, should one be interested in similar studies there are 1717 ongoing trials associated with infections and 38 that involve N-acetylcysteine actively recruiting patients."

Answered by AI
~10 spots leftby May 2025