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

NCT04374461 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 20-168
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid-19

Keywords

N-acetylcysteine; 20-168

Outcome Measures

Primary Outcomes (2)

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

  1 year

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

  1 year

Study Arms (2)

mechanically ventilated &/or managed in a critical-care

EXPERIMENTAL

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; Other: Peripheral Blood

non-mechanically ventilated, non-critical-care

EXPERIMENTAL

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; Other: Peripheral Blood

Interventions

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.

mechanically ventilated &/or managed in a critical-care; non-mechanically ventilated, non-critical-care

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.

mechanically ventilated &/or managed in a critical-care; non-mechanically ventilated, non-critical-care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• Arm B:
• requiring mechanical ventilation or admission to an intensive care unit at MSK (M11)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

COVID-19

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Santosha Vardhana, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 5, 2020
• Study Start: May 1, 2020
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)