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

• Sponsor: Cambridge Health Alliance (Other)
• Overall Status: Completed
• CT.gov ID: NCT04419025
• Collaborator: (none)
• Enrollment: 165
• Locations: 4
• Arms: 2
• Actual Duration (Months): 7.7
• Patients Per Site: 41.3
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
COVID; Sars-CoV2; SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere; Oxidative Stress	Drug: N-acetylcysteine	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 165 participants
• 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).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).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Determination of Efficacy of N-Acetylcysteine in Preventing Those With Mild or Moderate COVID-19 From Progressing to Severe Disease
• Actual Study Start Date: Sep 23, 2020
• Actual Primary Completion Date: May 14, 2021
• Actual Study Completion Date: May 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NAC Patients receiving N-acetylcysteine (NAC)	Drug: N-acetylcysteine; Oral formulation: 600 mg capsules of N-acetylcysteine; Other Names: NAC, acetylcysteine, N-acetyl-L-cysteine, NALC
No Intervention: Control Patients not receiving N-acetylcysteine (NAC)

Outcome Measures

Primary Outcome Measures

1. Decrease in Respiratory Rate [First hour after first dose of NAC]

   Decrease in dyspnea measured by respiratory rate (RR)

2. Hospital length of stay (LOS) [Through study completion, average 9 months]

   Hospital LOS for admitted patients

3. Need for mechanical ventilation [Through study completion, average 9 months]

   Whether a patient needed mechanical ventilation (intubation)

4. Length of time intubated [Through study completion, average 9 months]

   If intubated, how long needing mechanical ventilation

5. Need for hospitalization [Through study completion, average 9 months]

   Outpatients on NAC needing admission to the hospital

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHA Cambridge Hospital	Cambridge	Massachusetts	United States	02138
2	CHA Everett Hospital	Everett	Massachusetts	United States	02149
3	CHA Respiratory Clinic	Somerville	Massachusetts	United States	02143
4	CHA Somerville campus	Somerville	Massachusetts	United States	02144

Sponsors and Collaborators

• Cambridge Health Alliance

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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

Publications

None provided.

• Responsible Party: Melisa Lai-Becker, Chief, CHA Everett Hospital Emergency Department; Director, CHA Division of Medical Toxicology, Cambridge Health Alliance
• ClinicalTrials.gov Identifier: NCT04419025
• Other Study ID Numbers: CHA-IRB-1139/05/20
• First Posted: Jun 5, 2020
• Last Update Posted: May 28, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Melisa Lai-Becker, Chief, CHA Everett Hospital Emergency Department; Director, CHA Division of Medical Toxicology, Cambridge Health Alliance: Glutathione; Acetylcysteine; Oxidative stress; NAC; COVID; COVID-19; SARS-CoV2
• Additional relevant MeSH terms: COVID-19; Severe Acute Respiratory Syndrome; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of May 28, 2021