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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-23

Study Completion Date

2021-05-14

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

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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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NAC

Patients receiving N-acetylcysteine (NAC)

Group Type ACTIVE_COMPARATOR

N-acetylcysteine

Intervention Type DRUG

Oral formulation: 600 mg capsules of N-acetylcysteine

Control

Patients not receiving N-acetylcysteine (NAC)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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N-acetylcysteine

Oral formulation: 600 mg capsules of N-acetylcysteine

Intervention Type DRUG

Other Intervention Names

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NAC, acetylcysteine, N-acetyl-L-cysteine, NALC

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