← Back to Search

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 up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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

Select...

I am 18 years old or older.

Select...

I need extra oxygen to keep my oxygen levels normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met