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

Phase 2

Completed

• Conditions: Sars-CoV2; COVID; SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere; Oxidative Stress
• Interventions: Drug: N-acetylcysteine

• Registration Number: NCT04419025
• Lead Sponsor: Cambridge Health Alliance

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 Timeline

• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-05
• Study Start: 2020-09-23
• Status Verified: 2021-05
• Primary Completion: 2021-05-14
• Study Completion: 2021-05-14
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAC	N-acetylcysteine	Patients receiving N-acetylcysteine (NAC)

Primary Outcome Measures

Name	Time	Method
Recovery disposition	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
Decrease in Respiratory Rate	First hour after first dose of NAC	Decrease in dyspnea measured by respiratory rate (RR)
Hospital length of stay (LOS)	Through study completion, average 9 months	Hospital LOS for admitted patients
Need for mechanical ventilation	Through study completion, average 9 months	Whether a patient needed mechanical ventilation (intubation)
Length of time intubated	Through study completion, average 9 months	If intubated, how long needing mechanical ventilation
Need for hospitalization	Through study completion, average 9 months	Outpatients on NAC needing admission to the hospital

Trial Locations

Locations (4)

CHA Respiratory Clinic; 🇺🇸 Somerville, Massachusetts, United States

CHA Everett Hospital; 🇺🇸 Everett, Massachusetts, United States

CHA Cambridge Hospital; 🇺🇸 Cambridge, Massachusetts, United States

CHA Somerville campus; 🇺🇸 Somerville, Massachusetts, United States