NAC for Attenuation of COVID-19 Symptomatology (NACinCOVID2)

N-acetylcysteine for Attenuation of COVID Symptomatology

The objective of this study is to determine whether oral NAC is effective at attenuating COVID-19 disease symptom severity and duration of symptoms.

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19; Oxidative Stress; SARS-CoV2 Infection; COVID-19 Pneumonia; SARS-CoV-2 Acute Respiratory Disease; COVID-19 Respiratory Infection; SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere; COVID-19 Lower Respiratory Infection
• Intervention / Treatment: Other: Placebo; Drug: N-acetylcysteine

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)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Melisa Lai-Becker, MD; Phone Number: 617-394-7424; Email: melaibecker@cha.harvard.edu
• Study Contact Backup: Name: Tom Seufert, MD; Email: tseufert@cha.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Everett, Massachusetts, United States, 02149
      • Cambridge Health Alliance
      • Contact: Tom Seufert, MD; Email: tseufert@cha.harvard.edu
      • Contact: Melisa Lai-Becker, MD; Email: melaibecker@cha.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• positive COVID test <= 7 days of enrollment

Exclusion Criteria:

• pregnant
• already hospitalized due to COVID

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NAC; Group receiving intervention/study drug NAC	Drug: N-acetylcysteine; N-acetylcysteine; Other Names: NAC; Acetylcysteine; N-acetyl-cysteine
Placebo Comparator: Placebo; Group receiving placebo	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Cambridge Health Alliance
• Collaborators: The Thoracic Foundation; Alturix

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: N-acetylcysteine; NAC; N-acetyl-cysteine; glutathione; acetylcysteine
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Severe Acute Respiratory Syndrome; COVID-19; Infections; Communicable Diseases; Respiratory Tract Infections; Respiration Disorders; Respiratory Tract Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data used for publication
• IPD Sharing Time Frame: Available six months after publication for one year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• 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