Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease

Determination of Efficacy of N-Acetylcysteine in Preventing Those With Mild or Moderate COVID-19 From Progressing to Severe Disease

The purpose of this study is to assess the efficacy of N-acetylcysteine (NAC) in preventing those with mild or moderate COVID-19 from progressing to severe disease

Study Overview

• Status: Completed
• Conditions: COVID; Oxidative Stress; Sars-CoV2; SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
• Intervention / Treatment: Drug: N-acetylcysteine

Detailed Description

After being informed of the study and potential risks and benefits, patients meeting eligibility requirements will be randomized to receive oral N-acetylcysteine (NAC) as follows:

Inpatients:

• N-acetylcystine (NAC) 25 mg/kg PO (rounded up to the nearest 600 mg) q4hrs until discharge
• N-acetylcysteine (NAC) 1200 mg PO BID x 1 week post-discharge

Outpatients:

- N-acetylcysteine (NAC) 2400 mg PO x 1 then 1200 mg PO BID x 2 weeks

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • CHA Cambridge Hospital
    • Everett, Massachusetts, United States, 02149
      • CHA Everett Hospital
    • Somerville, Massachusetts, United States, 02143
      • CHA Respiratory Clinic
    • Somerville, Massachusetts, United States, 02144
      • CHA Somerville campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• known or suspect COVID-19 disease AND one or more of the following influenza-like symptoms, including: diarrhea vomiting fever (subjective or measured) chills myalgias fatigue sore throat headache cough nasal/sinus congestion or rhinorrhea shortness of breath chest pain

Exclusion Criteria:

• Minors, pregnant women and people unable to provide informed consent are excluded from this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NAC; Patients receiving N-acetylcysteine (NAC)	Drug: N-acetylcysteine; Oral formulation: 600 mg capsules of N-acetylcysteine; Other Names: NAC, acetylcysteine, N-acetyl-L-cysteine, NALC
No Intervention: Control; Patients not receiving N-acetylcysteine (NAC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in Respiratory Rate	Decrease in dyspnea measured by respiratory rate (RR)	First hour after first dose of NAC
Hospital length of stay (LOS)	Hospital LOS for admitted patients	Through study completion, average 9 months
Need for mechanical ventilation	Whether a patient needed mechanical ventilation (intubation)	Through study completion, average 9 months
Length of time intubated	If intubated, how long needing mechanical ventilation	Through study completion, average 9 months
Need for hospitalization	Outpatients on NAC needing admission to the hospital	Through study completion, average 9 months
Recovery disposition	Whether outpatients continued to recover as outpatients; whether admitted patients were managed on medical floors or level of care increased to ICU level of care; whether patients expired	Through study completion, average 9 months

Collaborators and Investigators

• Sponsor: Cambridge Health Alliance

Publications and helpful links

Helpful Links

• Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19
• Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19
• Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): May 14, 2021
• Study Completion (Actual): May 14, 2021

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Oxidative stress; COVID-19; COVID; SARS-CoV2; Glutathione; Acetylcysteine; NAC
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: CHA-IRB-1139/05/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Information that underlies results in published data
• IPD Sharing Time Frame: Six months after publication available for a year
• IPD Sharing Access Criteria: Written request; to be reviewed by the PI
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes