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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a single-institution study that will be open at MSKCC's Manhattan campus. Patients will be enrolled into 2 separate arms. The mechanically ventilated &/or managed in a critical-care arm is closed to accrual as of September 2020.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
mechanically ventilated &/or managed in a critical-care 		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
  • Drug: N-acetylcysteine
    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.
  • Other: Peripheral Blood
    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.
Experimental
non-mechanically ventilated, non-critical-care 		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
  • Drug: N-acetylcysteine
    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.
  • Other: Peripheral Blood
    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.

Recruiting Locations

More Details

NCT ID
NCT04374461
Status
Active, not recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.