NAC for Attenuation of COVID-19 Symptomatology

NCT05074121 | Unknown Phase 2 FDA Drug

• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 (1)

• Need for higher level of care/hospitalization

  24 weeks starting the day after enrollment

Study Arms (2)

NAC

EXPERIMENTAL

Group receiving intervention/study drug NAC

Drug: N-acetylcysteine

Placebo

PLACEBO COMPARATOR

Group receiving placebo

Other: Placebo

Interventions

N-acetylcysteine DRUG

N-acetylcysteine

Also known as: NAC, N-acetyl-cysteine, Acetylcysteine

NAC

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• positive COVID test \<= 7 days of enrollment

You may not qualify if:

• pregnant
• already hospitalized due to COVID

Sponsors & Collaborators

• Cambridge Health Alliance: lead
• The Thoracic Foundation: collaborator
• Alturix: collaborator

Study Sites (1)

Cambridge Health Alliance

Everett, Massachusetts, 02149, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Melisa Lai-Becker, MD

CONTACT

617-394-7424; melaibecker@cha.harvard.edu

Tom Seufert, MD

CONTACT

tseufert@cha.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants and study team members will be masked to whether a participant is receiving the study drug or placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, CHA Everett Emergency Department; Director, CHA Division of Medical Toxicology

Model Details: Randomized Double-Blinded Placebo-Controlled

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 12, 2021
• Study Start: March 31, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 1, 2025
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Available six months after publication for one year

Locations

US (1)