<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/NCT04455243</url>
  </required_header>
  <id_info>
    <org_study_id>E-20-4934</org_study_id>
    <nct_id>NCT04455243</nct_id>
  </id_info>
  <brief_title>Inflammatory Regulation Effect of NAC on COVID-19 Treatment</brief_title>
  <acronym>INFECT-19</acronym>
  <official_title>Pilot Double Blinded Randomized Placebo Controlled Multi Central Clinical Trial on Inflammatory Regulation Effect of NAC on COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Tariq Alhawassi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Saud University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult&#xD;
      admitted patients with COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2021</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Recovery</measure>
    <time_frame>28 days</time_frame>
    <description>Day of recovery is defined as the first day on which of the following three categories from The Ordinal Scale on Covid-19 Clinical Improvement&#xD;
Not-Hospitalized, No limitation on activity.&#xD;
Not Hospitalized, with limitation on activity.&#xD;
Hospitalized, Not requiring supplemental Oxygen</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1180</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N-Acetyl cysteine</intervention_name>
    <description>150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS)</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>NAC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo administered in the same schedule and volume as NAC</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult above 18 years of age&#xD;
&#xD;
          -  Admitted to the hospital With confirmed COVID-19 by RT-PCR test&#xD;
&#xD;
          -  On oxygen supplement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active use of NAC&#xD;
&#xD;
          -  Known NAC allergy&#xD;
&#xD;
          -  In the opinion of the treating team, progression of death is imminent and inevitable&#xD;
             within the next 24 hour, irrespective of provision treatment&#xD;
&#xD;
          -  All patients enrolled in any other investigational drug studies in COVID-19.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Baian Alabdulbaqi, MD</last_name>
    <phone>+966114670011</phone>
    <email>balabdulbaqi@ksu.edu.sa</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>King Saud University</investigator_affiliation>
    <investigator_full_name>Dr. Tariq Alhawassi</investigator_full_name>
    <investigator_title>Chairman of Clinical Trial Support Unit</investigator_title>
  </responsible_party>
  <keyword>NAC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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>Undecided</sharing_ipd>
    <ipd_description>IPD data will be shared. However, the exact sharing plans on what or when is not yet decided.</ipd_description>
  </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/NCT04455243
org study id: E-20-4934
nct id: NCT04455243
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult
      admitted patients with COVID-19.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to Recovery
time frame: 28 days
description: Day of recovery is defined as the first day on which of the following three categories from The Ordinal Scale on Covid-19 Clinical Improvement
Not-Hospitalized, No limitation on activity.
Not Hospitalized, with limitation on activity.
Hospitalized, Not requiring supplemental Oxygen
arm group label: Intervention group
arm group type: Experimental
arm group label: Control group
arm group type: Placebo Comparator
intervention type: Drug
intervention name: N-Acetyl cysteine
description: 150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS)
arm group label: Intervention group
other name: NAC
intervention type: Drug
intervention name: Placebo
description: Matching placebo administered in the same schedule and volume as NAC
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Baian Alabdulbaqi, MD
phone: +966114670011
email: balabdulbaqi@ksu.edu.sa
responsible party type: Sponsor-Investigator
investigator affiliation: King Saud University
investigator full name: Dr. Tariq Alhawassi
investigator title: Chairman of Clinical Trial Support Unit
mesh term: COVID-19
mesh term: Acetylcysteine
mesh term: N-monoacetylcystine
sharing ipd: Undecided
ipd description: IPD data will be shared. However, the exact sharing plans on what or when is not yet decided.