<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/NCT04416399</url>
  </required_header>
  <id_info>
    <org_study_id>STOIC study</org_study_id>
    <nct_id>NCT04416399</nct_id>
  </id_info>
  <brief_title>STerOids in COVID-19 Study</brief_title>
  <acronym>STOIC</acronym>
  <official_title>Use of High Dose Inhaled Corticosteroids as Treatment of Early COVID-19 Infection to Prevent Clinical Deterioration and Hospitalisation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>No</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>
      At the time of writing (3/4/2020), close to a million people have been infected by the&#xD;
      SARS-CoV-2 coronavirus around the world. The severe clinical condition that leads to deaths&#xD;
      is now called CoVID-19. Currently, there are no effective treatments for the early or late&#xD;
      stages of this illness. Governments worldwide have undertaken dramatic interventions to try&#xD;
      and reduce the rate of spread of this deadly coronavirus.&#xD;
&#xD;
      Early data from multiple studies in China, where the virus originated, show that severe cases&#xD;
      of CoVID-19 are not as prevalent in patients with chronic lung diseases as expected. This&#xD;
      data has been confirmed by the Italian physicians. The investigators think that the&#xD;
      widespread use of inhaled corticosteroids reduces the risk of CoVID-19 pneumonia in patients&#xD;
      with chronic lung disease. Early microbiological data also shows that these corticosteroids&#xD;
      are effective at slowing down the rate of coronavirus replication on lung cells.&#xD;
&#xD;
      Inhaled corticosteroids are widely used to manage common lung conditions, such as asthma.&#xD;
      This type of medicine is among the top 3 most common medication prescribed around the world.&#xD;
      Their safety is well understood, and their potential side effects are mild and reversible.&#xD;
&#xD;
      The investigators propose to test this idea that, in participants early in the course of&#xD;
      CoVID-19 illness, daily high dose inhaled corticosteroids for 28 days, will reduce the&#xD;
      chances of severe respiratory illness needing hospitalisation. We will also study the effect&#xD;
      of this inhaled therapy on symptoms and viral load.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Independent statistical review advice&#xD;
  </why_stopped>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Actual">January 12, 2021</completion_date>
  <primary_completion_date type="Actual">January 12, 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>Randomised, open label parallel group controlled clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emergency department attendance of hospitalisation related to COVID-19</measure>
    <time_frame>Day 1 to day 28</time_frame>
    <description>Evaluate the effect of intervention on emergency department attendance or hospitalisation related to COVID-19</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body temperature</measure>
    <time_frame>Day 1 to day 14</time_frame>
    <description>Evaluate the effect of intervention on body temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood oxygen saturation level</measure>
    <time_frame>Day 1 to day 14</time_frame>
    <description>Evaluate the effect of intervention on blood oxygen level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms as assessed by common cold questionnaire</measure>
    <time_frame>Day 1 to day 14</time_frame>
    <description>Evaluate the effect of intervention on patient's symptoms as determined by common cold questionnaire. Higher score meaning worse symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms as assessed by FluPro questionnaire</measure>
    <time_frame>Day 1 to day 14</time_frame>
    <description>Evaluate the effect of intervention on patient's symptoms as determined by FluPro questionnaire. Higher score meaning worse symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nasal/throat swab SARS-CoV-2 viral load</measure>
    <time_frame>Day 1, 7 and 14</time_frame>
    <description>Evaluate the effect of intervention on nasal and throat swab SARS-CoV-2 viral load</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Coronavirus Infection</condition>
  <arm_group>
    <arm_group_label>Inhaled budesonide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Budesonide dry powder inhaler</intervention_name>
    <description>Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day</description>
    <arm_group_label>Inhaled budesonide</arm_group_label>
    <other_name>Pulmicort</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             trial&#xD;
&#xD;
          -  Male or Female, aged 18 years or above&#xD;
&#xD;
          -  New onset of symptoms suggestive of COVID-19 e.g. new onset cough and/or fever, and/or&#xD;
             loss of smell or taste within 7 or fewer days of participant being seen at visit 1&#xD;
&#xD;
          -  In the Investigator's opinion, is able and willing to comply with all trial&#xD;
             requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A known allergy to investigational medicine product (IMP) (budesonide)&#xD;
&#xD;
          -  Any known contraindication to any of the IMPs (budesonide)&#xD;
&#xD;
          -  Patient currently prescribed inhaled or systemic corticosteroids&#xD;
&#xD;
          -  Recent use, within the previous 7 days of inhaled or systemic corticosteroids&#xD;
&#xD;
          -  Patient needs hospitalisation at time of study consent&#xD;
&#xD;
          -  Any other significant disease or disorder which, in the opinion of the Investigator,&#xD;
             may either put the participants at risk because of participation in the trial, or may&#xD;
             influence the result of the trial, or the participant's ability to participate in the&#xD;
             trial.&#xD;
&#xD;
          -  Participants who have participated in another research trial involving an&#xD;
             investigational product in the past 12 weeks.&#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_official>
    <last_name>Mona Bafadhel, MBBS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oxford Respiratory Trials Unit</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</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 4, 2020</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CoVID-19</keyword>
  <keyword>Coronavirus infection</keyword>
  <keyword>SARS-CoV-2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Budesonide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04416399
org study id: STOIC study
nct id: NCT04416399
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
At the time of writing (3/4/2020), close to a million people have been infected by the
      SARS-CoV-2 coronavirus around the world. The severe clinical condition that leads to deaths
      is now called CoVID-19. Currently, there are no effective treatments for the early or late
      stages of this illness. Governments worldwide have undertaken dramatic interventions to try
      and reduce the rate of spread of this deadly coronavirus.

      Early data from multiple studies in China, where the virus originated, show that severe cases
      of CoVID-19 are not as prevalent in patients with chronic lung diseases as expected. This
      data has been confirmed by the Italian physicians. The investigators think that the
      widespread use of inhaled corticosteroids reduces the risk of CoVID-19 pneumonia in patients
      with chronic lung disease. Early microbiological data also shows that these corticosteroids
      are effective at slowing down the rate of coronavirus replication on lung cells.

      Inhaled corticosteroids are widely used to manage common lung conditions, such as asthma.
      This type of medicine is among the top 3 most common medication prescribed around the world.
      Their safety is well understood, and their potential side effects are mild and reversible.

      The investigators propose to test this idea that, in participants early in the course of
      CoVID-19 illness, daily high dose inhaled corticosteroids for 28 days, will reduce the
      chances of severe respiratory illness needing hospitalisation. We will also study the effect
      of this inhaled therapy on symptoms and viral load.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised, open label parallel group controlled clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: Emergency department attendance of hospitalisation related to COVID-19
time frame: Day 1 to day 28
description: Evaluate the effect of intervention on emergency department attendance or hospitalisation related to COVID-19
measure: Body temperature
time frame: Day 1 to day 14
description: Evaluate the effect of intervention on body temperature
measure: Blood oxygen saturation level
time frame: Day 1 to day 14
description: Evaluate the effect of intervention on blood oxygen level
measure: Symptoms as assessed by common cold questionnaire
time frame: Day 1 to day 14
description: Evaluate the effect of intervention on patient's symptoms as determined by common cold questionnaire. Higher score meaning worse symptoms.
measure: Symptoms as assessed by FluPro questionnaire
time frame: Day 1 to day 14
description: Evaluate the effect of intervention on patient's symptoms as determined by FluPro questionnaire. Higher score meaning worse symptoms.
measure: Nasal/throat swab SARS-CoV-2 viral load
time frame: Day 1, 7 and 14
description: Evaluate the effect of intervention on nasal and throat swab SARS-CoV-2 viral load
arm group label: Inhaled budesonide
arm group type: Experimental
description: Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day
arm group label: Standard of care
arm group type: No Intervention
description: Standard of care
intervention type: Drug
intervention name: Budesonide dry powder inhaler
description: Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day
arm group label: Inhaled budesonide
other name: Pulmicort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mona Bafadhel, MBBS, PhD
role: Principal Investigator
affiliation: University of Oxford
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Infections
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Budesonide
sharing ipd: No