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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04419025
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Melisa Lai-Becker, Cambridge Health Alliance

Brief Summary:
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

Condition or disease Intervention/treatment Phase
COVID Sars-CoV2 SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere Oxidative Stress Drug: N-acetylcysteine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants are assigned to one of two groups in parallel for the duration of the study.

One arm is the intervention arm - those receiving N-acetylcysteine (NAC). One arm is the control group - those not receiving N-acetylcysteine (NAC).

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determination of Efficacy of N-Acetylcysteine in Preventing Those With Mild or Moderate COVID-19 From Progressing to Severe Disease
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NAC
Patients receiving N-acetylcysteine (NAC)
Drug: N-acetylcysteine
Oral formulation: 600 mg capsules of N-acetylcysteine
Other Name: NAC, acetylcysteine, N-acetyl-L-cysteine, NALC

No Intervention: Control
Patients not receiving N-acetylcysteine (NAC)



Primary Outcome Measures :
  1. Decrease in Respiratory Rate [ Time Frame: First hour after first dose of NAC ]
    Decrease in dyspnea measured by respiratory rate (RR)

  2. Hospital length of stay (LOS) [ Time Frame: Through study completion, average 9 months ]
    Hospital LOS for admitted patients

  3. Need for mechanical ventilation [ Time Frame: Through study completion, average 9 months ]
    Whether a patient needed mechanical ventilation (intubation)

  4. Length of time intubated [ Time Frame: Through study completion, average 9 months ]
    If intubated, how long needing mechanical ventilation

  5. Need for hospitalization [ Time Frame: Through study completion, average 9 months ]
    Outpatients on NAC needing admission to the hospital

  6. Recovery disposition [ Time Frame: Through study completion, average 9 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • known or suspect COVID-19 disease AND one or more of the following:

    • Oxygen saturation as measured by pulse oximetry (SpO2) <= 95% at rest on room air (i.e. with no supplemental oxygen)
    • Oxygen saturation as measured by pulse oximetry (SpO2) decreases to <= 90% on room air while walking (i.e. "ambulatory desaturation")
    • Respiratory Rate >= 24 breaths per minute
    • Fever defined as temperature >= 100.1° Fahrenheit
    • Radiographic evidence of pulmonary pathology consistent with COVID-19
    • Use of acetaminophen (APAP, paracetamol) for symptom control

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419025


Contacts
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Contact: Melisa Lai-Becker, MD 617-394-7424 melaibecker@cha.harvard.edu
Contact: Duncan Kuhn, MD dukuhn@cha.harvard.edu

Locations
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United States, Massachusetts
CHA Cambridge Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Melisa Lai-Becker, MD       melaibecker@cha.harvard.edu   
Contact: Duncan Kuhn, MD       dukuhn@cha.harvard.edu   
Sub-Investigator: Rachel Hathaway, MD         
Sub-Investigator: Alix Schrager, MD         
CHA Everett Hospital Recruiting
Everett, Massachusetts, United States, 02149
Contact: Melisa Lai-Becker, MD    617-394-7424    melaibecker@cha.harvard.edu   
Contact: Duncan Kuhn, MD       dukuhn@cha.harvard.edu   
Sub-Investigator: Mary Regan, PharmD         
CHA Respiratory Clinic Recruiting
Somerville, Massachusetts, United States, 02143
Contact: Lara Hall, MD       lahall@cha.harvard.edu   
Contact: Janice John, PA-C       jnjohn@cha.harvard.edu   
CHA Somerville campus Recruiting
Somerville, Massachusetts, United States, 02144
Contact: Melisa Lai-Becker, MD       melaibecker@cha.harvard.edu   
Sponsors and Collaborators
Cambridge Health Alliance
Additional Information:
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Responsible Party: Melisa Lai-Becker, Chief, CHA Everett Hospital Emergency Department; Director, CHA Division of Medical Toxicology, Cambridge Health Alliance
ClinicalTrials.gov Identifier: NCT04419025    
Other Study ID Numbers: CHA-IRB-1139/05/20
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Melisa Lai-Becker, Cambridge Health Alliance:
Glutathione
Acetylcysteine
Oxidative stress
NAC
COVID
COVID-19
SARS-CoV2
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes