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

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Cambridge Health Alliance

Status and phase

Completed
Phase 2

Conditions

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

Treatments

Drug: N-acetylcysteine

Study type

Interventional

Funder types

Other

Identifiers

NCT04419025
CHA-IRB-1139/05/20

Details and patient eligibility

About

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

Full 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

Enrollment

165 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

165 participants in 2 patient groups

NAC
Active Comparator group
Description:
Patients receiving N-acetylcysteine (NAC)
Treatment:
Drug: N-acetylcysteine
Control
No Intervention group
Description:
Patients not receiving N-acetylcysteine (NAC)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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