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Completed

NCT Number: NCT04419025

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

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

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Key information

Conditions

COVID COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Oxidative Stress Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere Sars-CoV2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHA Cambridge Hospital, Cambridge, Massachusetts, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine

Drug

Oral formulation: 600 mg capsules of N-acetylcysteine

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

Primary outcomes

  1. Decrease in Respiratory Rate

    Time frame: First hour after first dose of NAC

    Decrease in dyspnea measured by respiratory rate (RR)

  2. Hospital length of stay (LOS)

    Time frame: Through study completion, average 9 months

    Hospital LOS for admitted patients

  3. Need for mechanical ventilation

    Time frame: Through study completion, average 9 months

    Whether a patient needed mechanical ventilation (intubation)

  4. Length of time intubated

    Time frame: Through study completion, average 9 months

    If intubated, how long needing mechanical ventilation

  5. Need for hospitalization

    Time frame: Through study completion, average 9 months

    Outpatients on NAC needing admission to the hospital

  6. Recovery disposition

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cambridge Health Alliance

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2020
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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