<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/NCT04435795</url>
  </required_header>
  <id_info>
    <org_study_id>2021-6696</org_study_id>
    <nct_id>NCT04435795</nct_id>
  </id_info>
  <brief_title>Inhaled Ciclesonide for Outpatients With COVID19</brief_title>
  <acronym>CONTAIN</acronym>
  <official_title>Ciclesonide Clinical Trial for COVID-19 Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The CONTAIN (CiclesOnide cliNical TriAl covId-19 treatmeNt) is a randomized control study of&#xD;
      ciclesonide vs placebo for mild covid-19 disease. The need for potential therapy for COVID-19&#xD;
      patients is urgent. Ciclesonide has shown encouraging in vitro results, is easy to be used&#xD;
      and is readily available. It has a low rate of side effects and few interactions with other&#xD;
      drugs. It is unusual to use an inhaled steroid drug for COVID-19 but there has been new data&#xD;
      suggesting steroids may have an antiviral effect in addition to an anti-inflammatory effect.&#xD;
      Investigators propose to use inhaled and nasal ciclesonide to stop viral replication in the&#xD;
      nose and airways. Investigators hope this will accelerate recovery from COVID-19 illness in&#xD;
      individuals who are not admitted to hospital at time of diagnosis of COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    could not meet target enrolment&#xD;
  </why_stopped>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">July 8, 2021</completion_date>
  <primary_completion_date type="Actual">June 8, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea</measure>
    <time_frame>day 7</time_frame>
    <description>Proportion of participants with no symptoms of cough, fever or dyspnea at day 7</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea</measure>
    <time_frame>Day 14</time_frame>
    <description>Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Feeling: Proportion Who Are Reporting That They Are &quot;Very Much Improved&quot; or &quot;Much Improved&quot; at Day 7</measure>
    <time_frame>Day 7</time_frame>
    <description>Proportion who are reporting that they are &quot;very much improved&quot; or &quot;much improved&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Feeling: Proportion Who Are Reporting That They Are &quot;Very Much Improved&quot; or &quot;Much Improved&quot; at Day 14</measure>
    <time_frame>Day 14</time_frame>
    <description>Proportion who are reporting that they are &quot;very much improved&quot; or &quot;much improved&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Dyspnea: Resolution of Dyspnea at Day 7</measure>
    <time_frame>day 7</time_frame>
    <description>Dyspnea was defined as reporting &quot;shortness of breath&quot; or &quot;chest congestion&quot; or &quot;chest tightness&quot;. In those who reported dyspnea at baseline, resolution will be defined as having no symptoms in these three areas.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7</measure>
    <time_frame>day 7</time_frame>
    <description>Improvement of wet or dry cough. Analysis limited to patients who reported cough at baseline. Defined as a 2 point decrease, or a decrease to 0 on a visual analogue scale that ranged from 0 for no symptoms to 10 for severe symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Hospitalized for SARS-CoV-2</measure>
    <time_frame>day 14</time_frame>
    <description>Hospitalization for SARS-CoV-2 related illness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>day 29</time_frame>
    <description>All cause mortality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">215</enrollment>
  <condition>COVID 19</condition>
  <arm_group>
    <arm_group_label>Ciclesonide inhaled and nasal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline intranasal and placebo inhaler</intervention_name>
    <description>Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ciclesonide</intervention_name>
    <description>Ciclesonide 600mcg BID inhaled with aero chamber</description>
    <arm_group_label>Ciclesonide inhaled and nasal</arm_group_label>
    <other_name>Alvesco</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ciclesonide nasal</intervention_name>
    <description>intranasal ciclesonide 200 mcg DIE</description>
    <arm_group_label>Ciclesonide inhaled and nasal</arm_group_label>
    <other_name>Omnaris</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Symptomatic adult patients positive by PCR for COVID-19 within 5 days of enrollment with&#xD;
        fever, cough, or shortness of breath. Provision of Informed Consent&#xD;
&#xD;
        At day 0, patients should be at home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already on inhaled corticosteroid medication&#xD;
&#xD;
          -  Currently using systemic steroids (oral or intravenous or intramuscular such as&#xD;
             Prednisone) or use of steroids 7 days prior to enrolment&#xD;
&#xD;
          -  Severely ill patients at enrollment (i.e., admitted to ICU at admission)&#xD;
&#xD;
          -  Unable to self-administer the inhaler&#xD;
&#xD;
          -  Known or suspected pregnancy and breastfeeding&#xD;
&#xD;
          -  Known allergy to study medication or its components (non-medicinal ingredients;&#xD;
             including lactose allergy (type I))&#xD;
&#xD;
          -  Patients with untreated fungal, bacterial, or tubercular infections of the respiratory&#xD;
             tract&#xD;
&#xD;
          -  Current hospitalization&#xD;
&#xD;
          -  Current use of oxygen at home or in the hospital&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Center</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3K 2M2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <results_first_submitted>April 21, 2022</results_first_submitted>
  <results_first_submitted_qc>April 21, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 29, 2022</results_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Nicole Ezer, MD, FRCPC, MPH</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <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>Ciclesonide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 23, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT04435795/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrolment to the trial began on 15 September 2020 in Quebec, 9 February 2021 in Ontario, and 22 March 2021 in British Columbia. The last participants were recruited on 8 June 2021.</recruitment_details>
      <pre_assignment_details>Overall, 215 participants were randomised, and the modified intention-to-treat population included 203 adults with respiratory symptoms or fever.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Ciclesonide Inhaled and Nasal</title>
          <description>Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days&#xD;
Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber&#xD;
Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID&#xD;
Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="107"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ciclesonide Inhaled and Nasal</title>
          <description>Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days&#xD;
Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber&#xD;
Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID&#xD;
Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="105"/>
            <count group_id="B2" value="98"/>
            <count group_id="B3" value="203"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35" lower_limit="27" upper_limit="47"/>
                    <measurement group_id="B2" value="35" lower_limit="27" upper_limit="45"/>
                    <measurement group_id="B3" value="35" lower_limit="27" upper_limit="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <category_list>
                <category>
                  <title>African canadian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Middle Eastern</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>South Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <title>British Columbia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ontario</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Quebec</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea</title>
        <description>Proportion of participants with no symptoms of cough, fever or dyspnea at day 7</description>
        <time_frame>day 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ciclesonide Inhaled and Nasal</title>
            <description>Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days&#xD;
Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber&#xD;
Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID&#xD;
Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea</title>
          <description>Proportion of participants with no symptoms of cough, fever or dyspnea at day 7</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea</title>
        <description>Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14</description>
        <time_frame>Day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ciclesonide Inhaled and Nasal</title>
            <description>Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days&#xD;
Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber&#xD;
Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID&#xD;
Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea</title>
          <description>Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Feeling: Proportion Who Are Reporting That They Are &quot;Very Much Improved&quot; or &quot;Much Improved&quot; at Day 7</title>
        <description>Proportion who are reporting that they are &quot;very much improved&quot; or &quot;much improved&quot;</description>
        <time_frame>Day 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ciclesonide Inhaled and Nasal</title>
            <description>Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days&#xD;
Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber&#xD;
Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID&#xD;
Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Feeling: Proportion Who Are Reporting That They Are &quot;Very Much Improved&quot; or &quot;Much Improved&quot; at Day 7</title>
          <description>Proportion who are reporting that they are &quot;very much improved&quot; or &quot;much improved&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Feeling: Proportion Who Are Reporting That They Are &quot;Very Much Improved&quot; or &quot;Much Improved&quot; at Day 14</title>
        <description>Proportion who are reporting that they are &quot;very much improved&quot; or &quot;much improved&quot;</description>
        <time_frame>Day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ciclesonide Inhaled and Nasal</title>
            <description>Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days&#xD;
Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber&#xD;
Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID&#xD;
Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Feeling: Proportion Who Are Reporting That They Are &quot;Very Much Improved&quot; or &quot;Much Improved&quot; at Day 14</title>
          <description>Proportion who are reporting that they are &quot;very much improved&quot; or &quot;much improved&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Dyspnea: Resolution of Dyspnea at Day 7</title>
        <description>Dyspnea was defined as reporting &quot;shortness of breath&quot; or &quot;chest congestion&quot; or &quot;chest tightness&quot;. In those who reported dyspnea at baseline, resolution will be defined as having no symptoms in these three areas.</description>
        <time_frame>day 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ciclesonide Inhaled and Nasal</title>
            <description>Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days&#xD;
Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber&#xD;
Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID&#xD;
Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Dyspnea: Resolution of Dyspnea at Day 7</title>
          <description>Dyspnea was defined as reporting &quot;shortness of breath&quot; or &quot;chest congestion&quot; or &quot;chest tightness&quot;. In those who reported dyspnea at baseline, resolution will be defined as having no symptoms in these three areas.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7</title>
        <description>Improvement of wet or dry cough. Analysis limited to patients who reported cough at baseline. Defined as a 2 point decrease, or a decrease to 0 on a visual analogue scale that ranged from 0 for no symptoms to 10 for severe symptoms</description>
        <time_frame>day 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ciclesonide Inhaled and Nasal</title>
            <description>Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days&#xD;
Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber&#xD;
Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID&#xD;
Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7</title>
          <description>Improvement of wet or dry cough. Analysis limited to patients who reported cough at baseline. Defined as a 2 point decrease, or a decrease to 0 on a visual analogue scale that ranged from 0 for no symptoms to 10 for severe symptoms</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Hospitalized for SARS-CoV-2</title>
        <description>Hospitalization for SARS-CoV-2 related illness</description>
        <time_frame>day 14</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ciclesonide Inhaled and Nasal</title>
            <description>Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days&#xD;
Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber&#xD;
Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID&#xD;
Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Hospitalized for SARS-CoV-2</title>
          <description>Hospitalization for SARS-CoV-2 related illness</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality</title>
        <description>All cause mortality</description>
        <time_frame>day 29</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ciclesonide Inhaled and Nasal</title>
            <description>Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days&#xD;
Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber&#xD;
Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID&#xD;
Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality</title>
          <description>All cause mortality</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>29 Days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ciclesonide Inhaled and Nasal</title>
          <description>Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days&#xD;
Ciclesonide: Ciclesonide 600mcg BID inhaled with aero chamber&#xD;
Ciclesonide nasal: intranasal ciclesonide 200 mcg DIE</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID&#xD;
Normal Saline intranasal and placebo inhaler: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospithalization</sub_title>
                <description>SAE related to COVID-19, not to the study drug</description>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Visit to the emergency department</sub_title>
                <description>Related to COVID-19, not to the study drug</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Severe headache</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Voice change</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>throat irritaiton</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Dry nose, irritated nose or nosebleed</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Wheeze</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Thrush</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>We were unable to recruit the intended sample size given a rapid decline in cases of covid-19 in Canada following increases in vaccination.&#xD;
In addition, we did not enrich the study population for older high risk people and cannot exclude a possible benefit in earlier symptom resolution and prevention of clinical deterioration in this group.&#xD;
As our trial was stopped prematurely, we might have been underpowered to show a small benefit of ciclesonide on early symptom resolution</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr Nicole EZER</name_or_title>
      <organization>Research Institute of the McGill University Health Center</organization>
      <phone>514-934-1934 ext 76192</phone>
      <email>nicole.ezer@mcgill.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04435795
org study id: 2021-6696
nct id: NCT04435795
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The CONTAIN (CiclesOnide cliNical TriAl covId-19 treatmeNt) is a randomized control study of
      ciclesonide vs placebo for mild covid-19 disease. The need for potential therapy for COVID-19
      patients is urgent. Ciclesonide has shown encouraging in vitro results, is easy to be used
      and is readily available. It has a low rate of side effects and few interactions with other
      drugs. It is unusual to use an inhaled steroid drug for COVID-19 but there has been new data
      suggesting steroids may have an antiviral effect in addition to an anti-inflammatory effect.
      Investigators propose to use inhaled and nasal ciclesonide to stop viral replication in the
      nose and airways. Investigators hope this will accelerate recovery from COVID-19 illness in
      individuals who are not admitted to hospital at time of diagnosis of COVID-19.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea
time frame: day 7
description: Proportion of participants with no symptoms of cough, fever or dyspnea at day 7
measure: Proportion of Participants With no Symptoms of Cough, Fever or Dyspnea
time frame: Day 14
description: Proportion of participants with no symptoms of cough, fever or dyspnea at Day 14
measure: Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 7
time frame: Day 7
description: Proportion who are reporting that they are "very much improved" or "much improved"
measure: Overall Feeling: Proportion Who Are Reporting That They Are "Very Much Improved" or "Much Improved" at Day 14
time frame: Day 14
description: Proportion who are reporting that they are "very much improved" or "much improved"
measure: Improvement in Dyspnea: Resolution of Dyspnea at Day 7
time frame: day 7
description: Dyspnea was defined as reporting "shortness of breath" or "chest congestion" or "chest tightness". In those who reported dyspnea at baseline, resolution will be defined as having no symptoms in these three areas.
measure: Improvement in Cough at Day 7: Proportion of Patient With a Reduction of Cough Symptoms at Day 7
time frame: day 7
description: Improvement of wet or dry cough. Analysis limited to patients who reported cough at baseline. Defined as a 2 point decrease, or a decrease to 0 on a visual analogue scale that ranged from 0 for no symptoms to 10 for severe symptoms
measure: Proportion of Participants Hospitalized for SARS-CoV-2
time frame: day 14
description: Hospitalization for SARS-CoV-2 related illness
measure: Mortality
time frame: day 29
description: All cause mortality
arm group label: Ciclesonide inhaled and nasal
arm group type: Active Comparator
description: Intranasal ciclesonide BID 50mcg BID to each nostril and inhaled ciclesonide 600mcg BID x 14 days
arm group label: Placebo
arm group type: Placebo Comparator
description: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
intervention type: Drug
intervention name: Normal Saline intranasal and placebo inhaler
description: Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
arm group label: Placebo
intervention type: Drug
intervention name: Ciclesonide
description: Ciclesonide 600mcg BID inhaled with aero chamber
arm group label: Ciclesonide inhaled and nasal
other name: Alvesco
intervention type: Drug
intervention name: Ciclesonide nasal
description: intranasal ciclesonide 200 mcg DIE
arm group label: Ciclesonide inhaled and nasal
other name: Omnaris
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Nicole Ezer, MD, FRCPC, MPH
investigator title: Assistant Professor of Medicine
mesh term: COVID-19
mesh term: Ciclesonide
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: We were unable to recruit the intended sample size given a rapid decline in cases of covid-19 in Canada following increases in vaccination.
In addition, we did not enrich the study population for older high risk people and cannot exclude a possible benefit in earlier symptom resolution and prevention of clinical deterioration in this group.
As our trial was stopped prematurely, we might have been underpowered to show a small benefit of ciclesonide on early symptom resolution
point of contact: 