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

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

Sponsors

Lead Sponsor: Cambridge Health Alliance

Source 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

Overall Status Completed
Start Date 2020-09-23
Completion Date 2021-05-14
Primary Completion Date 2021-05-14
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Decrease in Respiratory Rate First hour after first dose of NAC
Hospital length of stay (LOS) Through study completion, average 9 months
Need for mechanical ventilation Through study completion, average 9 months
Length of time intubated Through study completion, average 9 months
Need for hospitalization Through study completion, average 9 months
Recovery disposition Through study completion, average 9 months
Enrollment 165
Condition
Intervention

Intervention Type: Drug

Intervention Name: N-acetylcysteine

Description: Oral formulation: 600 mg capsules of N-acetylcysteine

Arm Group Label: NAC

Other Name: NAC, acetylcysteine, N-acetyl-L-cysteine, NALC

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Melisa Lai-Becker, MD

Phone: 617-394-7424

Email: [email protected]

Location
Facility:
CHA Cambridge Hospital | Cambridge, Massachusetts, 02138, United States
CHA Everett Hospital | Everett, Massachusetts, 02149, United States
CHA Respiratory Clinic | Somerville, Massachusetts, 02143, United States
CHA Somerville campus | Somerville, Massachusetts, 02144, United States
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Cambridge Health Alliance

Investigator Full Name: Melisa Lai-Becker

Investigator Title: Chief, CHA Everett Hospital Emergency Department; Director, CHA Division of Medical Toxicology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: NAC

Type: Active Comparator

Description: Patients receiving N-acetylcysteine (NAC)

Label: Control

Type: No Intervention

Description: Patients not receiving N-acetylcysteine (NAC)

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention 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).

Primary Purpose: Treatment

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News