<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/NCT04403269</url>
  </required_header>
  <id_info>
    <org_study_id>P20/07 GERONIMO 19</org_study_id>
    <nct_id>NCT04403269</nct_id>
  </id_info>
  <brief_title>NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER, COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE</brief_title>
  <acronym>GERONIMO 19</acronym>
  <official_title>&quot;STUDY OF THE EFFICIENCY OF NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE&quot; GERONIMO 19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Versailles Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Versailles Hospital</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>
      According to recent data, death rate is more than 20% for 75 years old hospitalized patients&#xD;
      and older.&#xD;
&#xD;
      In case of aggravation, according to the latest observations, if they are refused for&#xD;
      mechanical ventilation in intensive care, their death rate could reach 60% even for patients&#xD;
      without comorbidity.&#xD;
&#xD;
      Apart from an increase in oxygen therapy, no specific treatment is currently proposed.&#xD;
&#xD;
      The control of the inflammatory component seems to be a key element to be able to influence&#xD;
      the patients' health evolution.&#xD;
&#xD;
      Polyvalent intravenous immunoglobilins have immunomodulatory and anti-inflammatory properties&#xD;
      with a favorable safety profile for these elderly patients and several clinical cases lead to&#xD;
      positive impact in the caring for Covid patients.&#xD;
&#xD;
      This study objective is evaluation of the efficacy of polyvalent IVIg in combination with the&#xD;
      standard management of patients aged 75 and over with SARSCov2 infection with acute&#xD;
      respiratory failure (saturation ≤ 95%) requiring oxygen therapy&gt; 5 L / min (i.e. patients&#xD;
      considered as moderate to severe ARDS according to the Berlin definition, Pa02 / Fi02≤200)&#xD;
      and disqualified from a care in the ICU.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 5, 2020</start_date>
  <completion_date type="Anticipated">May 5, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 5, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>Day 14</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total number of days of full hospitalization</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of oxygen therapy</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferritin level in the blood</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP level in the blood</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDH level in the blood</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lymphocyte level in the blood</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PNN level in the blood</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>platelet level in the blood</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHO performance index</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHOQOL-OLD questionnaire</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function by pulmonary computed tomography</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function by EFR</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission Rates</measure>
    <time_frame>3 and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>IgIV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental arm is human immunoglobulins. 2 infusion at D1 and D2. (0.8 g / kg by IV infusion)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IgIV</intervention_name>
    <description>2 infusion at D1 and D2 (0.8 g / kg by IV infusion)</description>
    <arm_group_label>IgIV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman aged 75 and over&#xD;
&#xD;
          -  SARS-coV2 infection confirmed by RT-PCR or thoraco-pulmonary CT&#xD;
&#xD;
          -  Hospitalized in the acute general geriatrics unit of the Versailles Hospital Center&#xD;
&#xD;
          -  Patient rejected from resuscitation&#xD;
&#xD;
          -  Saturation ≤ 95% under oxygen therapy&gt; 5 L / min (i.e. PaO2 / FiO2≤200mmHg according&#xD;
             to the Berlin definition of ARDS) by means of a nasal cannula, a high concentration&#xD;
             facial mask or another device similar oxygen distribution&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under palliative care&#xD;
&#xD;
          -  Patient with contraindication to IV polyvalent Ig&#xD;
&#xD;
               1. . Hypersensitivity to the active substance or to any of the excipients&#xD;
                  (L-proline)&#xD;
&#xD;
               2. . Hypersensitivity to human immunoglobulins, especially when the patient has&#xD;
                  anti-IgA antibodies,&#xD;
&#xD;
               3. . Patients with type I or II hyperprolinemia&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
&#xD;
          -  Patient receiving another experimental treatment as part of an interventional study&#xD;
&#xD;
          -  Moderate to severe dementia known: it must have been diagnosed before hospitalization&#xD;
             and is defined by an MMSE &lt;20/30 or a neuropsychological assessment with a diagnosis&#xD;
             made.&#xD;
&#xD;
          -  Patient not affiliated with a social security system in France&#xD;
&#xD;
          -  ADL patients &lt;4/6 and / or IADL &lt;6/8&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mélody FORT</last_name>
    <phone>+33139239776</phone>
    <email>mfort@ch-versailles.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Hospitalier de Versailles</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78150</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laure PARNET</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Versailles Hospital</investigator_affiliation>
    <investigator_full_name>Dr Laure PARNET</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <!-- 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/NCT04403269
org study id: P20/07 GERONIMO 19
nct id: NCT04403269
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
According to recent data, death rate is more than 20% for 75 years old hospitalized patients
      and older.

      In case of aggravation, according to the latest observations, if they are refused for
      mechanical ventilation in intensive care, their death rate could reach 60% even for patients
      without comorbidity.

      Apart from an increase in oxygen therapy, no specific treatment is currently proposed.

      The control of the inflammatory component seems to be a key element to be able to influence
      the patients' health evolution.

      Polyvalent intravenous immunoglobilins have immunomodulatory and anti-inflammatory properties
      with a favorable safety profile for these elderly patients and several clinical cases lead to
      positive impact in the caring for Covid patients.

      This study objective is evaluation of the efficacy of polyvalent IVIg in combination with the
      standard management of patients aged 75 and over with SARSCov2 infection with acute
      respiratory failure (saturation ≤ 95%) requiring oxygen therapy> 5 L / min (i.e. patients
      considered as moderate to severe ARDS according to the Berlin definition, Pa02 / Fi02≤200)
      and disqualified from a care in the ICU.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mortality
time frame: Day 14
measure: Total number of days of full hospitalization
time frame: 3 and 6 months
measure: Duration of oxygen therapy
time frame: 3 and 6 months
measure: Ferritin level in the blood
time frame: 3 and 6 months
measure: CRP level in the blood
time frame: 3 and 6 months
measure: LDH level in the blood
time frame: 3 and 6 months
measure: Lymphocyte level in the blood
time frame: 3 and 6 months
measure: PNN level in the blood
time frame: 3 and 6 months
measure: platelet level in the blood
time frame: 3 and 6 months
measure: WHO performance index
time frame: 3 and 6 months
measure: WHOQOL-OLD questionnaire
time frame: 3 and 6 months
measure: Lung function by pulmonary computed tomography
time frame: 3 and 6 months
measure: Lung function by EFR
time frame: 3 and 6 months
measure: Mortality
time frame: 3 and 6 months
measure: Readmission Rates
time frame: 3 and 6 months
arm group label: IgIV
arm group type: Experimental
description: The experimental arm is human immunoglobulins. 2 infusion at D1 and D2. (0.8 g / kg by IV infusion)
intervention type: Drug
intervention name: IgIV
description: 2 infusion at D1 and D2 (0.8 g / kg by IV infusion)
arm group label: IgIV
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Mélody FORT
phone: +33139239776
email: mfort@ch-versailles.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Versailles Hospital
investigator full name: Dr Laure PARNET
investigator title: Principal Investigator
mesh term: Respiratory Insufficiency