N-acetylcysteine for COVID-19

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Mechanical ventilation, ICU admission, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Santosha Vardhana, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

You have tested positive for COVID-19.

I need extra oxygen to keep my oxygen levels normal.

Patients with certain types of blood cancers may be allowed to join the study after their doctor reviews their blood test results.

Exclusion Criteria

You need a machine to help you breathe or have to stay in a special hospital unit at MSK.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive N-acetylcysteine IV 6 g/day for a maximum of 3 weeks or until specific clinical endpoints are met

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• N-acetylcysteine

Trial Overview 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.

Participant Groups

Group I: non-mechanically ventilated, non-critical-care Experimental Treatment 2 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-care Experimental Treatment 2 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

N-acetylcysteine is already approved in United States, European Union for the following indications:

Approved in United States as N-acetylcysteine for:

• Acetaminophen overdose
• Chronic bronchitis
• Cystic fibrosis
• Mucolytic agent

Approved in European Union as N-acetylcysteine for:

• Paracetamol overdose
• Chronic bronchitis
• Cystic fibrosis
• Mucolytic agent

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+