NAC for Attenuation of COVID-19 Symptomatology | NCT05074121

Studies
NAC for Attenuation of COVID-19 Symptomatology

NCT05074121

Sponsor

Cambridge Health Alliance

Status

Unknown status

Last Update Posted

Aug 7, 2023Actual

Enrollment

200Estimated

Phase

Phase 2

Conditions

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

Interventions

N-acetylcysteine
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2024Estimated

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Feb 1, 2025Estimated

First Submitted Date

Oct 5, 2021

First Submission Date that Met QC Criteria

Oct 5, 2021

First Posted Date

Oct 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2023

Last Update Posted Date

Aug 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Melisa Lai-Becker, Chief, CHA Everett Emergency Department; Director, CHA Division of Medical Toxicology, Cambridge Health AlliancePrincipal Investigator

Lead Sponsor

Cambridge Health AllianceOTHER

Collaborators

Name	Class
The Thoracic Foundation	UNKNOWN
Alturix	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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)

Conditions Module

Conditions

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NAC	Experimental	Group receiving intervention/study drug NAC	Drug: N-acetylcysteine
Placebo	Placebo Comparator	Group receiving placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N-acetylcysteine	Drug	N-acetylcysteine	NAC	NAC N-acetyl-cysteine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptom severity	Severity of symptoms	24 weeks starting the day after enrollment
Symptom duration	Length in days of symptoms	24 weeks starting the day after enrollment

Secondary Outcomes

Measure	Description	Time Frame
Need for higher level of care/hospitalization	Comparison between groups of rates of hospitalization	24 weeks starting the day after enrollment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

positive COVID test <= 7 days of enrollment

Exclusion Criteria:

pregnant
already hospitalized due to COVID

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Melisa Lai-Becker, MD	Contact	617-394-7424		melaibecker@cha.harvard.edu
Tom Seufert, MD	Contact			tseufert@cha.harvard.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cambridge Health Alliance		Everett	Massachusetts	02149	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study data used for publication

Types

Study Protocol
Informed Consent Form (ICF)

Time Frame

Available six months after publication for one year

Access Criteria

Not provided

URL

http://www.NACinCOVID.info

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins