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

Study Overview
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Brief Summary
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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
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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

Official Title
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Determination of Efficacy of N-Acetylcysteine in Preventing Those With Mild or Moderate COVID-19 From Progressing to Severe Disease

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

Intervention / Treatment
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* Drug: N-acetylcysteine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NAC<br>Patients receiving N-acetylcysteine (NAC) | Drug: N-acetylcysteine<br>* Oral formulation: 600 mg capsules of N-acetylcysteine<br>* Other names: NAC, acetylcysteine, N-acetyl-L-cysteine, NALC;|
| No Intervention: Control<br>Patients not receiving N-acetylcysteine (NAC) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAC, Glutathione, Acetylcysteine, Oxidative stress, COVID, COVID-19, SARS-CoV2