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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04419025
Recruitment Status : Completed
First Posted : June 5, 2020
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Melisa Lai-Becker, Cambridge Health Alliance

Tracking Information
First Submitted Date  ICMJE June 3, 2020
First Posted Date  ICMJE June 5, 2020
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE September 23, 2020
Actual Primary Completion Date May 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2020)
  • Decrease in Respiratory Rate [ Time Frame: First hour after first dose of NAC ]
    Decrease in dyspnea measured by respiratory rate (RR)
  • Hospital length of stay (LOS) [ Time Frame: Through study completion, average 9 months ]
    Hospital LOS for admitted patients
  • Need for mechanical ventilation [ Time Frame: Through study completion, average 9 months ]
    Whether a patient needed mechanical ventilation (intubation)
  • Length of time intubated [ Time Frame: Through study completion, average 9 months ]
    If intubated, how long needing mechanical ventilation
  • Need for hospitalization [ Time Frame: Through study completion, average 9 months ]
    Outpatients on NAC needing admission to the hospital
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease
Official Title  ICMJE Determination of Efficacy of N-Acetylcysteine in Preventing Those With Mild or Moderate COVID-19 From Progressing to Severe Disease
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • COVID
  • Sars-CoV2
  • SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
  • Oxidative Stress
Intervention  ICMJE Drug: N-acetylcysteine
Oral formulation: 600 mg capsules of N-acetylcysteine
Other Name: NAC, acetylcysteine, N-acetyl-L-cysteine, NALC
Study Arms  ICMJE
  • Active Comparator: NAC
    Patients receiving N-acetylcysteine (NAC)
    Intervention: Drug: N-acetylcysteine
  • No Intervention: Control
    Patients not receiving N-acetylcysteine (NAC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2021)
165
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2020)
200
Actual Study Completion Date  ICMJE May 14, 2021
Actual Primary Completion Date May 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04419025
Other Study ID Numbers  ICMJE CHA-IRB-1139/05/20
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Information that underlies results in published data
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Six months after publication available for a year
Access Criteria: Written request; to be reviewed by the PI
URL: http://www.NACinCOVID.info
Responsible Party Melisa Lai-Becker, Cambridge Health Alliance
Study Sponsor  ICMJE Cambridge Health Alliance
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cambridge Health Alliance
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP