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

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419025
• Other study ID #: CHA-IRB-1139/05/20
• Status: Completed
• Phase: Phase 2
• Start date: September 23, 2020
• Est. completion date: May 14, 2021

Study information

• Verified date: May 2021
• Source: Cambridge Health Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: May 14, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Oxidative Stress
• SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
• Sars-CoV2
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• N-acetylcysteine
Oral formulation: 600 mg capsules of N-acetylcysteine

Locations

Country	Name	City	State
United States	CHA Cambridge Hospital	Cambridge	Massachusetts
United States	CHA Everett Hospital	Everett	Massachusetts
United States	CHA Respiratory Clinic	Somerville	Massachusetts
United States	CHA Somerville campus	Somerville	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge Health Alliance

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19
•   Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19
•   Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19