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

Primary Purpose

COVID, Sars-CoV2, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-acetylcysteine
Sponsored by
Cambridge Health Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID focused on measuring Glutathione, Acetylcysteine, Oxidative stress, NAC, COVID, COVID-19, SARS-CoV2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHA Cambridge Hospital
  • CHA Everett Hospital
  • CHA Respiratory Clinic
  • CHA Somerville campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

NAC

Control

Arm Description

Patients receiving N-acetylcysteine (NAC)

Patients not receiving N-acetylcysteine (NAC)

Outcomes

Primary Outcome Measures

Decrease in Respiratory Rate
Decrease in dyspnea measured by respiratory rate (RR)
Hospital length of stay (LOS)
Hospital LOS for admitted patients
Need for mechanical ventilation
Whether a patient needed mechanical ventilation (intubation)
Length of time intubated
If intubated, how long needing mechanical ventilation
Need for hospitalization
Outpatients on NAC needing admission to the hospital
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

Secondary Outcome Measures

Full Information

First Posted
June 3, 2020
Last Updated
May 26, 2021
Sponsor
Cambridge Health Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT04419025
Brief Title
Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease
Official Title
Determination of Efficacy of N-Acetylcysteine in Preventing Those With Mild or Moderate COVID-19 From Progressing to Severe Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
May 14, 2021 (Actual)
Study Completion Date
May 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge Health Alliance

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Sars-CoV2, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, Oxidative Stress
Keywords
Glutathione, Acetylcysteine, Oxidative stress, NAC, COVID, COVID-19, SARS-CoV2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAC
Arm Type
Active Comparator
Arm Description
Patients receiving N-acetylcysteine (NAC)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients not receiving N-acetylcysteine (NAC)
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
NAC, acetylcysteine, N-acetyl-L-cysteine, NALC
Intervention Description
Oral formulation: 600 mg capsules of N-acetylcysteine
Primary Outcome Measure Information:
Title
Decrease in Respiratory Rate
Description
Decrease in dyspnea measured by respiratory rate (RR)
Time Frame
First hour after first dose of NAC
Title
Hospital length of stay (LOS)
Description
Hospital LOS for admitted patients
Time Frame
Through study completion, average 9 months
Title
Need for mechanical ventilation
Description
Whether a patient needed mechanical ventilation (intubation)
Time Frame
Through study completion, average 9 months
Title
Length of time intubated
Description
If intubated, how long needing mechanical ventilation
Time Frame
Through study completion, average 9 months
Title
Need for hospitalization
Description
Outpatients on NAC needing admission to the hospital
Time Frame
Through study completion, average 9 months
Title
Recovery disposition
Description
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
Time Frame
Through study completion, average 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CHA Cambridge Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
Facility Name
CHA Everett Hospital
City
Everett
State/Province
Massachusetts
ZIP/Postal Code
02149
Country
United States
Facility Name
CHA Respiratory Clinic
City
Somerville
State/Province
Massachusetts
ZIP/Postal Code
02143
Country
United States
Facility Name
CHA Somerville campus
City
Somerville
State/Province
Massachusetts
ZIP/Postal Code
02144
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.NACinCOVID.info
Links:
URL
http://www.NACinCOVID.info
Description
Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19
URL
http://www.NACinCOVID.net
Description
Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19
URL
http://www.NACinCOVID.org
Description
Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19

Learn more about this trial

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

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