<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/NCT04469491</url>
  </required_header>
  <id_info>
    <org_study_id>PI2020_843_0041</org_study_id>
    <nct_id>NCT04469491</nct_id>
  </id_info>
  <brief_title>Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study</brief_title>
  <acronym>COV-NI</acronym>
  <official_title>Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      COVID-19 is causing a serious viral pandemic in terms of health and social impact. To date,&#xD;
      no treatment has yet demonstrated Strong efficacy in treating the infectious disease&#xD;
      (COVID-19). Pulmonary administration of Interferon (IFN) type I is a therapeutic strategy&#xD;
      with high potential,due to higher local concentrations and minimal adverse effects. Type I&#xD;
      interferons (including IFN-α and IFN-β) are antiviral defence cytokines and also have the&#xD;
      potential to negatively modulate IFN Type II and IL-6 dependent cytokine storm, the latter&#xD;
      being induced in the late forms of COVID-19. In vitro, IFN-β were more effective on COVID-19&#xD;
      than IFN-α. In existing preliminary studies, only patients receiving IFN type I modulators&#xD;
      have a decrease in viral carriage and a rapid reversal. The purpose of this project is to&#xD;
      assess in hospitalized patients with oxygen for COVID 19, the clinical efficacy on oxygen&#xD;
      requirements of the addition of inhaled Interferon type I compared to the control arm .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2020</start_date>
  <completion_date type="Actual">September 12, 2023</completion_date>
  <primary_completion_date type="Actual">June 16, 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>oxygen requirement score at day 0</measure>
    <time_frame>day 0</time_frame>
    <description>oxygen requirement score at day 0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>oxygen requirement score at day 15</measure>
    <time_frame>day 15</time_frame>
    <description>oxygen requirement score at day 15</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Variation oxygen requirement score between day 0 and day15</measure>
    <time_frame>at day 15</time_frame>
    <description>Variation oxygen requirement score between day 0 and day15</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>COVID-19</condition>
  <condition>INTERFERON</condition>
  <condition>NEBULIZATION</condition>
  <arm_group>
    <arm_group_label>Inhaled IFN arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IFN (Interferon) pulmonary (Inhalation) + routine care (+/- antibiotics; +/- dexamethasone; + appropriate O2 support)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm:</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aerosol (WFI water and routine care (+/- antibiotics;+/- dexamethasone; + appropriate O2 support).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>inhaled type I interferon</intervention_name>
    <description>The interventional arm includes inhaled interferon (9.6 MUI x2/d for 48 hours, then 9.6 MUI x1/d for 8 to 16 days or discharge), in addition to standard care. In phase B, maximum treatment duration is 8 days.</description>
    <arm_group_label>Inhaled IFN arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>WFI water nebulization</intervention_name>
    <description>The interventional arm includes a WFI water nebulization comparator.</description>
    <arm_group_label>Control Arm:</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Patient with laboratory-confirmed SARS-CoV-2 infection as determined by PCR &lt; 96 h (at&#xD;
             initial diagnosis or persistent carriage &lt;96 h)&#xD;
&#xD;
          -  Hospitalized patient with COVID-19 requiring oxygen therapy&#xD;
&#xD;
        And targeting in phase B :&#xD;
&#xD;
          -  Patients under oxygen therapy such as nasal cannula/mask or non-invasive ventilation&#xD;
             with paO2/FiO2 &gt; 200 mmHg.&#xD;
&#xD;
          -  Patients hospitalized for less than 7 days.&#xD;
&#xD;
          -  Patients with symptoms for less than 10 days or RT-PCR (&lt;96h) with Cycle Treshold &lt;&#xD;
             25.&#xD;
&#xD;
          -  Social security coverage&#xD;
&#xD;
          -  signed informed consent (by patient or their legally authorized representative)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to natural or recombinant interferon-ß&#xD;
&#xD;
          -  Hypersensitivity to human albumin or mannitol&#xD;
&#xD;
          -  Recent suicide attempt&#xD;
&#xD;
          -  Decompensation of liver failure&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  Pregnant or nursing.&#xD;
&#xD;
          -  Patients managed on an outpatient basis (i.e. not initially hospitalized).&#xD;
&#xD;
          -  Parenteral IFN treatment. In periode B, addition of new exclusion criteria&#xD;
&#xD;
          -  Patients with kidney transplant&#xD;
&#xD;
          -  Immunocompromised patients&#xD;
&#xD;
          -  Patients with severe systemic disease constantly threatening their vital prognosis&#xD;
             (ASA ≥ IV: e.g. severe ARF, advanced cancer pathology, recent myocardial IDM, severe&#xD;
             valvular dysfunction, dependence on parenteral nutrition on central line, shock,&#xD;
             sepsis, trauma, ...).&#xD;
&#xD;
          -  Patients in septic shock.&#xD;
&#xD;
          -  Patients with documented fungal infection.&#xD;
&#xD;
          -  Patients on mechanical ventilation.&#xD;
&#xD;
          -  Patients hospitalized for COVID-19 for more than 7 days.&#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>Jean-Philippe Lanoix, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Amiens</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CH d'Abbeville</name>
      <address>
        <city>Abbeville</city>
        <zip>80142</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80480</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Compiègne-Noyon</name>
      <address>
        <city>Compiegne</city>
        <zip>60200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de l'Arrondissement de Montreuil-sur-mer</name>
      <address>
        <city>Rang-du-Fliers</city>
        <zip>62180</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Saint-Quentin</name>
      <address>
        <city>Saint-Quentin</city>
        <zip>02100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Tourcoing</name>
      <address>
        <city>Tourcoing</city>
        <zip>59208</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de valenciennes</name>
      <address>
        <city>Valenciennes</city>
        <zip>59322</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>INTERFERON</keyword>
  <keyword>NEBULIZATION</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>Interferons</mesh_term>
    <mesh_term>Interferon Type I</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/NCT04469491
org study id: PI2020_843_0041
nct id: NCT04469491
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19 is causing a serious viral pandemic in terms of health and social impact. To date,
      no treatment has yet demonstrated Strong efficacy in treating the infectious disease
      (COVID-19). Pulmonary administration of Interferon (IFN) type I is a therapeutic strategy
      with high potential,due to higher local concentrations and minimal adverse effects. Type I
      interferons (including IFN-α and IFN-β) are antiviral defence cytokines and also have the
      potential to negatively modulate IFN Type II and IL-6 dependent cytokine storm, the latter
      being induced in the late forms of COVID-19. In vitro, IFN-β were more effective on COVID-19
      than IFN-α. In existing preliminary studies, only patients receiving IFN type I modulators
      have a decrease in viral carriage and a rapid reversal. The purpose of this project is to
      assess in hospitalized patients with oxygen for COVID 19, the clinical efficacy on oxygen
      requirements of the addition of inhaled Interferon type I compared to the control arm .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: oxygen requirement score at day 0
time frame: day 0
description: oxygen requirement score at day 0
measure: oxygen requirement score at day 15
time frame: day 15
description: oxygen requirement score at day 15
measure: Variation oxygen requirement score between day 0 and day15
time frame: at day 15
description: Variation oxygen requirement score between day 0 and day15
arm group label: Inhaled IFN arm
arm group type: Experimental
description: IFN (Interferon) pulmonary (Inhalation) + routine care (+/- antibiotics; +/- dexamethasone; + appropriate O2 support)
arm group label: Control Arm:
arm group type: Active Comparator
description: Aerosol (WFI water and routine care (+/- antibiotics;+/- dexamethasone; + appropriate O2 support).
intervention type: Drug
intervention name: inhaled type I interferon
description: The interventional arm includes inhaled interferon (9.6 MUI x2/d for 48 hours, then 9.6 MUI x1/d for 8 to 16 days or discharge), in addition to standard care. In phase B, maximum treatment duration is 8 days.
arm group label: Inhaled IFN arm
intervention type: Drug
intervention name: WFI water nebulization
description: The interventional arm includes a WFI water nebulization comparator.
arm group label: Control Arm:
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Philippe Lanoix, MD
role: Principal Investigator
affiliation: CHU Amiens
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Interferons
mesh term: Interferon Type I
sharing ipd: No