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NCT Number: NCT04374461

A Study of N-acetylcysteine in Patients With COVID-19 Infection

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

N-acetylcysteine

Drug

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. Treatment interruptions for up to 48 hours are permissible if there is a clinical indication to hold the study drug. Patients can restart drug if they have been off drug for less than 48 hours. Patients are also eligible to restart N-acetylcysteine treatment on the same treatment arm without reconsent if they are within the 30 day followup period after their prior course of treatment on this protocol.

Peripheral Blood

Other

A total of 16mL of research whole blood will be collected in CPT tubes at baseline, Cycle 2 Day 1 (or as close as feasible, when still coordinating sample collection across patients in a critical-care unit), and at end of study.

Primary outcomes

  1. Arm A: number of patients who are successfully extubated and/or transferred out of critical care due to clinical improvement

    Time frame: 1 year

  2. Arm B: number of patients who are discharged from the hospital due to clinical improvement

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Phase II Study of N-acetylcysteine in Severe or Critically Ill Patients With Refractory COVID-19 Infection

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
May 5, 2020
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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