<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04419025</url>
  </required_header>
  <id_info>
    <org_study_id>CHA-IRB-1139/05/20</org_study_id>
    <nct_id>NCT04419025</nct_id>
  </id_info>
  <brief_title>Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease</brief_title>
  <official_title>Determination of Efficacy of N-Acetylcysteine in Preventing Those With Mild or Moderate COVID-19 From Progressing to Severe Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cambridge Health Alliance</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cambridge Health Alliance</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy of N-acetylcysteine (NAC) in preventing&#xD;
      those with mild or moderate COVID-19 from progressing to severe disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After being informed of the study and potential risks and benefits, patients meeting&#xD;
      eligibility requirements will be randomized to receive oral N-acetylcysteine (NAC) as&#xD;
      follows:&#xD;
&#xD;
      Inpatients:&#xD;
&#xD;
        -  N-acetylcystine (NAC) 25 mg/kg PO (rounded up to the nearest 600 mg) q4hrs until&#xD;
           discharge&#xD;
&#xD;
        -  N-acetylcysteine (NAC) 1200 mg PO BID x 1 week post-discharge&#xD;
&#xD;
      Outpatients:&#xD;
&#xD;
      - N-acetylcysteine (NAC) 2400 mg PO x 1 then 1200 mg PO BID x 2 weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2020</start_date>
  <completion_date type="Actual">May 14, 2021</completion_date>
  <primary_completion_date type="Actual">May 14, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants are assigned to one of two groups in parallel for the duration of the study.&#xD;
One arm is the intervention arm - those receiving N-acetylcysteine (NAC). One arm is the control group - those not receiving N-acetylcysteine (NAC).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease in Respiratory Rate</measure>
    <time_frame>First hour after first dose of NAC</time_frame>
    <description>Decrease in dyspnea measured by respiratory rate (RR)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital length of stay (LOS)</measure>
    <time_frame>Through study completion, average 9 months</time_frame>
    <description>Hospital LOS for admitted patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Need for mechanical ventilation</measure>
    <time_frame>Through study completion, average 9 months</time_frame>
    <description>Whether a patient needed mechanical ventilation (intubation)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of time intubated</measure>
    <time_frame>Through study completion, average 9 months</time_frame>
    <description>If intubated, how long needing mechanical ventilation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Need for hospitalization</measure>
    <time_frame>Through study completion, average 9 months</time_frame>
    <description>Outpatients on NAC needing admission to the hospital</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recovery disposition</measure>
    <time_frame>Through study completion, average 9 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">165</enrollment>
  <condition>COVID</condition>
  <condition>Sars-CoV2</condition>
  <condition>SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere</condition>
  <condition>Oxidative Stress</condition>
  <arm_group>
    <arm_group_label>NAC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receiving N-acetylcysteine (NAC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients not receiving N-acetylcysteine (NAC)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N-acetylcysteine</intervention_name>
    <description>Oral formulation: 600 mg capsules of N-acetylcysteine</description>
    <arm_group_label>NAC</arm_group_label>
    <other_name>NAC, acetylcysteine, N-acetyl-L-cysteine, NALC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  known or suspect COVID-19 disease AND one or more of the following influenza-like&#xD;
             symptoms, including: diarrhea vomiting fever (subjective or measured) chills myalgias&#xD;
             fatigue sore throat headache cough nasal/sinus congestion or rhinorrhea shortness of&#xD;
             breath chest pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minors, pregnant women and people unable to provide informed consent are excluded from&#xD;
             this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHA Cambridge Hospital</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHA Everett Hospital</name>
      <address>
        <city>Everett</city>
        <state>Massachusetts</state>
        <zip>02149</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHA Respiratory Clinic</name>
      <address>
        <city>Somerville</city>
        <state>Massachusetts</state>
        <zip>02143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHA Somerville campus</name>
      <address>
        <city>Somerville</city>
        <state>Massachusetts</state>
        <zip>02144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.NACinCOVID.info</url>
    <description>Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19</description>
  </link>
  <link>
    <url>http://www.NACinCOVID.net</url>
    <description>Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19</description>
  </link>
  <link>
    <url>http://www.NACinCOVID.org</url>
    <description>Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>May 26, 2021</last_update_submitted>
  <last_update_submitted_qc>May 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cambridge Health Alliance</investigator_affiliation>
    <investigator_full_name>Melisa Lai-Becker</investigator_full_name>
    <investigator_title>Chief, CHA Everett Hospital Emergency Department; Director, CHA Division of Medical Toxicology</investigator_title>
  </responsible_party>
  <keyword>Glutathione</keyword>
  <keyword>Acetylcysteine</keyword>
  <keyword>Oxidative stress</keyword>
  <keyword>NAC</keyword>
  <keyword>COVID</keyword>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Severe Acute Respiratory Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetylcysteine</mesh_term>
    <mesh_term>N-monoacetylcystine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Information that underlies results in published data</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Six months after publication available for a year</ipd_time_frame>
    <ipd_access_criteria>Written request; to be reviewed by the PI</ipd_access_criteria>
    <ipd_url>http://www.NACinCOVID.info</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04419025
org study id: CHA-IRB-1139/05/20
nct id: NCT04419025
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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
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
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)
measure: Decrease in Respiratory Rate
time frame: First hour after first dose of NAC
description: Decrease in dyspnea measured by respiratory rate (RR)
measure: Hospital length of stay (LOS)
time frame: Through study completion, average 9 months
description: Hospital LOS for admitted patients
measure: Need for mechanical ventilation
time frame: Through study completion, average 9 months
description: Whether a patient needed mechanical ventilation (intubation)
measure: Length of time intubated
time frame: Through study completion, average 9 months
description: If intubated, how long needing mechanical ventilation
measure: Need for hospitalization
time frame: Through study completion, average 9 months
description: Outpatients on NAC needing admission to the hospital
measure: Recovery disposition
time frame: Through study completion, average 9 months
description: 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
arm group label: NAC
arm group type: Active Comparator
description: Patients receiving N-acetylcysteine (NAC)
arm group label: Control
arm group type: No Intervention
description: Patients not receiving N-acetylcysteine (NAC)
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
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.NACinCOVID.info
description: Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19
url: http://www.NACinCOVID.net
description: Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19
url: http://www.NACinCOVID.org
description: Website reviewing reasoning and references for using NAC as adjuvant therapy in treatment of COVID-19
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
mesh term: COVID-19
mesh term: Severe Acute Respiratory Syndrome
mesh term: Acetylcysteine
mesh term: N-monoacetylcystine
sharing ipd: Yes
ipd description: Information that underlies results in published data
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Six months after publication available for a year
ipd access criteria: Written request; to be reviewed by the PI
ipd url: http://www.NACinCOVID.info