Back to resultsNAC for Attenuation of COVID-19 Symptomatology (NACinCOVID2)
Primary Purpose
Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-acetylcysteine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring acetylcysteine, N-acetylcysteine, N-acetyl-cysteine, NAC, glutathione
Eligibility Criteria
Inclusion Criteria:
- positive COVID test <= 7 days of enrollment
Exclusion Criteria:
- pregnant
- already hospitalized due to COVID
Sites / Locations
- Cambridge Health Alliance
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NAC
Placebo
Arm Description
Group receiving intervention/study drug NAC
Group receiving placebo
Outcomes
Primary Outcome Measures
Symptom severity
Severity of symptoms
Symptom duration
Length in days of symptoms
Secondary Outcome Measures
Need for higher level of care/hospitalization
Comparison between groups of rates of hospitalization
Full Information
NCT ID
NCT05074121
First Posted
October 5, 2021
Last Updated
August 4, 2023
Sponsor
Cambridge Health Alliance
Collaborators
The Thoracic Foundation, Alturix
1. Study Identification
Unique Protocol Identification Number
NCT05074121
Brief Title
NAC for Attenuation of COVID-19 Symptomatology
Acronym
NACinCOVID2
Official Title
N-acetylcysteine for Attenuation of COVID Symptomatology
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 31, 2024 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge Health Alliance
Collaborators
The Thoracic Foundation, Alturix
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to determine whether oral NAC is effective at attenuating COVID-19 disease symptom severity and duration of symptoms.
Detailed Description
STUDY DESIGN: Randomized double-blinded placebo-controlled trial
ELIGIBILITY
Inclusion criteria:
age 18 years and older
participants will need daily access to use of a smartphone for at least six weeks from time of enrollment
Positive COVID-19 test within 10 days of date of enrollment
not already hospitalized for treatment of COVID
Exclusion criteria:
pregnant
already hospitalized for treatment of COVID
PROTOCOL
50:50 randomization: half of participants will take NAC, half will take placebo
Participants will take NAC/placebo following this outpatient protocol:
2400 mg x 1 PO then
1200 mg PO BID x 14 days
Participants will complete an online symptom-tracker for six weeks (daily for three weeks, weekly for three weeks)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Lower Respiratory Infection, SARS-CoV2 Infection, SARS-CoV-2 Acute Respiratory Disease, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, Oxidative Stress
Keywords
acetylcysteine, N-acetylcysteine, N-acetyl-cysteine, NAC, glutathione
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized Double-Blinded Placebo-Controlled
Masking
ParticipantCare ProviderInvestigator
Masking Description
Participants and study team members will be masked to whether a participant is receiving the study drug or placebo
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NAC
Arm Type
Experimental
Arm Description
Group receiving intervention/study drug NAC
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group receiving placebo
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
NAC, N-acetyl-cysteine, Acetylcysteine
Intervention Description
N-acetylcysteine
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Symptom severity
Description
Severity of symptoms
Time Frame
24 weeks starting the day after enrollment
Title
Symptom duration
Description
Length in days of symptoms
Time Frame
24 weeks starting the day after enrollment
Secondary Outcome Measure Information:
Title
Need for higher level of care/hospitalization
Description
Comparison between groups of rates of hospitalization
Time Frame
24 weeks starting the day after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
positive COVID test <= 7 days of enrollment
Exclusion Criteria:
pregnant
already hospitalized due to COVID
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melisa Lai-Becker, MD
Phone
617-394-7424
Email
melaibecker@cha.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Seufert, MD
Email
tseufert@cha.harvard.edu
Facility Information:
Facility Name
Cambridge Health Alliance
City
Everett
State/Province
Massachusetts
ZIP/Postal Code
02149
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melisa Lai-Becker, MD
Email
melaibecker@cha.harvard.edu
First Name & Middle Initial & Last Name & Degree
Tom Seufert, MD
Email
tseufert@cha.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study data used for publication
IPD Sharing Time Frame
Available six months after publication for one year
IPD Sharing URL
http://www.NACinCOVID.info
Learn more about this trial
NAC for Attenuation of COVID-19 Symptomatology
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