Determination of Efficacy of N-Acetylcysteine in Preventing Those With Mild or Moderate COVID-19 From Progressing to Severe Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Cambridge Health Alliance
- Enrollment
- 165
- Locations
- 4
- Primary Endpoint
- Recovery disposition
Study Overview
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
NAC
Patients receiving N-acetylcysteine (NAC)
Intervention: N-acetylcysteine (Drug)
Outcomes
Primary Outcomes
Recovery disposition
Time Frame: Through study completion, average 9 months
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
Need for mechanical ventilation
Time Frame: Through study completion, average 9 months
Whether a patient needed mechanical ventilation (intubation)
Decrease in Respiratory Rate
Time Frame: First hour after first dose of NAC
Decrease in dyspnea measured by respiratory rate (RR)
Hospital length of stay (LOS)
Time Frame: Through study completion, average 9 months
Hospital LOS for admitted patients
Length of time intubated
Time Frame: Through study completion, average 9 months
If intubated, how long needing mechanical ventilation
Need for hospitalization
Time Frame: Through study completion, average 9 months
Outpatients on NAC needing admission to the hospital
Secondary Outcomes
No secondary outcomes reported
Investigators
Melisa Lai-Becker
Chief, CHA Everett Hospital Emergency Department; Director, CHA Division of Medical Toxicology
Cambridge Health Alliance