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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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).
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
NAC 		Patients receiving N-acetylcysteine (NAC)
  • Drug: N-acetylcysteine
    Oral formulation: 600 mg capsules of N-acetylcysteine
    Other names:
    • NAC, acetylcysteine, N-acetyl-L-cysteine, NALC
No Intervention
Control 		Patients not receiving N-acetylcysteine (NAC)

Recruiting Locations

More Details

NCT ID
NCT04419025
Status
Completed
Sponsor
Cambridge Health Alliance

Detailed 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