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

Phase 2CompletedNCT04419025

Cambridge Health Alliance165 enrolled

Overview

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

After being informed of the study and potential risks and benefits, patients meeting eligibility requirements will be randomized to receive oral N-acetylcysteine (NAC) as follows: Inpatients: * N-acetylcystine (NAC) 25 mg/kg PO (rounded up to the nearest 600 mg) q4hrs until discharge * N-acetylcysteine (NAC) 1200 mg PO BID x 1 week post-discharge Outpatients: \- N-acetylcysteine (NAC) 2400 mg PO x 1 then 1200 mg PO BID x 2 weeks

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

165

Conditions

COVID Sars-CoV2 SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere Oxidative Stress

Interventions

N-acetylcysteineDRUG

Oral formulation: 600 mg capsules of N-acetylcysteine

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Minors, pregnant women and people unable to provide informed consent are excluded from this study

Locations (4)

CHA Cambridge Hospital

Cambridge, Massachusetts, United States

CHA Everett Hospital

Everett, Massachusetts, United States

CHA Respiratory Clinic

Somerville, Massachusetts, United States

CHA Somerville campus

Somerville, Massachusetts, United States

Outcomes

Primary Outcomes

Decrease in Respiratory Rate

Decrease in dyspnea measured by respiratory rate (RR)

Time frame: First hour after first dose of NAC

Hospital length of stay (LOS)

Hospital LOS for admitted patients