NAC for Attenuation of COVID-19 Symptomatology

Study Overview
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Brief Summary
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The objective of this study is to determine whether oral NAC is effective at attenuating COVID-19 disease symptom severity and duration of symptoms.

Detailed Description
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STUDY DESIGN: Randomized double-blinded placebo-controlled trial ELIGIBILITY Inclusion criteria: age 18 years and older participants will need daily access to use of a smartphone for at least six weeks from time of enrollment Positive COVID-19 test within 10 days of date of enrollment not already hospitalized for treatment of COVID Exclusion criteria: pregnant already hospitalized for treatment of COVID PROTOCOL 50:50 randomization: half of participants will take NAC, half will take placebo Participants will take NAC/placebo following this outpatient protocol: 2400 mg x 1 PO then 1200 mg PO BID x 14 days Participants will complete an online symptom-tracker for six weeks (daily for three weeks, weekly for three weeks)

Official Title
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N-acetylcysteine for Attenuation of COVID Symptomatology

Conditions
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Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Lower Respiratory Infection, SARS-CoV2 Infection, SARS-CoV-2 Acute Respiratory Disease, SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere, Oxidative Stress

Intervention / Treatment
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* Drug: N-acetylcysteine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: positive COVID test <= 7 days of enrollment Exclusion Criteria: pregnant already hospitalized due to COVID

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: Randomized Double-Blinded Placebo-Controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAC<br>Group receiving intervention/study drug NAC | Drug: N-acetylcysteine<br>* N-acetylcysteine<br>* Other names: Acetylcysteine;|
| Placebo Comparator: Placebo<br>Group receiving placebo | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom severity | Severity of symptoms | 24 weeks starting the day after enrollment | 
| Symptom duration | Length in days of symptoms | 24 weeks starting the day after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for higher level of care/hospitalization | Comparison between groups of rates of hospitalization | 24 weeks starting the day after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acetylcysteine, N-acetylcysteine, N-acetyl-cysteine, NAC, glutathione