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

NCT04419025 | Completed Phase 2 FDA Drug

• 1 other identifier: CHA-IRB-1139/05/20
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 4

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

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Decrease in Respiratory Rate

  Decrease in dyspnea measured by respiratory rate (RR)

  First hour after first dose of NAC

• Hospital length of stay (LOS)

  Hospital LOS for admitted patients

  Through study completion, average 9 months

• Need for mechanical ventilation

  Whether a patient needed mechanical ventilation (intubation)

  Through study completion, average 9 months

• Length of time intubated

  If intubated, how long needing mechanical ventilation

  Through study completion, average 9 months

• Need for hospitalization

  Outpatients on NAC needing admission to the hospital

  Through study completion, average 9 months

• 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

  Through study completion, average 9 months

Study Arms (2)

NAC

ACTIVE COMPARATOR

Patients receiving N-acetylcysteine (NAC)

Drug: N-acetylcysteine

Control

NO INTERVENTION

Patients not receiving N-acetylcysteine (NAC)

Interventions

N-acetylcysteine DRUG

Oral formulation: 600 mg capsules of N-acetylcysteine

Also known as: NAC, acetylcysteine, N-acetyl-L-cysteine, NALC

NAC

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Minors, pregnant women and people unable to provide informed consent are excluded from this study

Sponsors & Collaborators

• Cambridge Health Alliance: lead

Study Sites (4)

CHA Cambridge Hospital

Cambridge, Massachusetts, 02138, United States

Location

CHA Everett Hospital

Everett, Massachusetts, 02149, United States

Location

CHA Respiratory Clinic

Somerville, Massachusetts, 02143, United States

Location

CHA Somerville campus

Somerville, Massachusetts, 02144, United States

Location

Related Links

• Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19
• Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19
• Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, CHA Everett Hospital Emergency Department; Director, CHA Division of Medical Toxicology

Model Details: 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).

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: September 23, 2020
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Six months after publication available for a year
• Access Criteria: Written request; to be reviewed by the PI

Locations

US (4)