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

Cambridge Health Alliance

Status and phase: Completed; Phase 2

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

Treatments: Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT04419025

CHA-IRB-1139/05/20

Details and patient eligibility

About

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

Full description

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

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

NAC

Active Comparator group

Description:

Patients receiving N-acetylcysteine (NAC)

Treatment:

Drug: N-acetylcysteine

Control

No Intervention group

Description:

Patients not receiving N-acetylcysteine (NAC)