<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/NCT04438980</url>
  </required_header>
  <id_info>
    <org_study_id>CORTIVID</org_study_id>
    <nct_id>NCT04438980</nct_id>
  </id_info>
  <brief_title>Glucocorticoids in COVID-19 (CORTIVID)</brief_title>
  <acronym>CORTIVID</acronym>
  <official_title>Treatment of COVID-19 Pneumonia With Glucocorticoids. A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion Miguel Servet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Complejo Hospitalario de Navarra</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Sant Joan Despí Moisès Broggi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacion Miguel Servet</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>
      Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state&#xD;
      whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the&#xD;
      early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this&#xD;
      setting remains controversial. This study aims to assess the safety and effectiveness of GC&#xD;
      pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen&#xD;
      inflammatory biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">April 9, 2021</completion_date>
  <primary_completion_date type="Actual">March 12, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients developing treatment failure</measure>
    <time_frame>At 14 days after randomization</time_frame>
    <description>• Death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients developing treatment failure</measure>
    <time_frame>At 14 days after randomization</time_frame>
    <description>• Need for admission in an intensive care unit (ICU)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients developing treatment failure</measure>
    <time_frame>At 14 days after randomization</time_frame>
    <description>• Need for mechanical ventilation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients developing treatment failure</measure>
    <time_frame>At 14 days after randomization</time_frame>
    <description>• Decrease in SpO2 &lt;90% (in ambient air) or PaO2 &lt;60 mmHg (in ambient air) or PaO2FiO2 &lt;300 mmHg, associated with radiological impairment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality at day 28</measure>
    <time_frame>At 28 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients requiring ICU admission</measure>
    <time_frame>At 28 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients requiring rescue-therapy with tocilizumab</measure>
    <time_frame>At 14 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>At 28 days after randomization</time_frame>
    <description>Time in days from randomization until the date of hospital discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of severe adverse events</measure>
    <time_frame>At 28 days after randomization</time_frame>
    <description>Any undesirable experience related to the use of the studied drugs, which causes patient's death, life-threatening risk, hospitalization or extension of a previous hospitalization, disability or permanent damage, requires intervention to prevent permanent impairment or damage, or is considered medically relevant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of bacterial, fungal or opportunistic infections</measure>
    <time_frame>At 28 days after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of inflammatory biomarkers related to COVID-19</measure>
    <time_frame>At 14 days after randomization</time_frame>
    <description>Change in plasma levels of C-reactive protein (CRP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of inflammatory biomarkers related to COVID-19</measure>
    <time_frame>At 14 days after randomization</time_frame>
    <description>Change in plasma levels of ferritin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of inflammatory biomarkers related to COVID-19</measure>
    <time_frame>At 14 days after randomization</time_frame>
    <description>Change in plasma levels of interleukin-6 (IL-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of inflammatory biomarkers related to COVID-19</measure>
    <time_frame>At 14 days after randomization</time_frame>
    <description>Change in plasma levels of lactate dehydrogenase (LDH)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evolution of inflammatory biomarkers related to COVID-19</measure>
    <time_frame>At 14 days after randomization</time_frame>
    <description>Change in plasma levels of D-dimer (DD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of SARS-CoV-2 clearance.</measure>
    <time_frame>At 7 days after randomization</time_frame>
    <description>Negativization of RT-PCR for SARS-CoV-2 on nasopharyngeal swab or sputum</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Covid-19 Pneumonia</condition>
  <arm_group>
    <arm_group_label>Methylprednisolone Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard of care plus Methylprednisolone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard of care plus placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone</intervention_name>
    <description>-A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión</description>
    <arm_group_label>Methylprednisolone Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>-An infusion bag of 100 mL of 0.9% saline</description>
    <arm_group_label>Placebo Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years old.&#xD;
&#xD;
          -  Diagnosis of SARS-CoV-2 pneumonia confirmed by reverse transcriptase polymerase chain&#xD;
             reaction (RT-PCR) on nasopharyngeal swab or sputum according to the recommendations of&#xD;
             the Spanish Ministry of Health.&#xD;
&#xD;
          -  Length of symptoms consistent with COVID-19 ≥7 days.&#xD;
&#xD;
          -  Hospital admission.&#xD;
&#xD;
          -  At least one of the following: CRP &gt;60 mg/L, IL-6 &gt;40 pg/mL, ferritin &gt;1000 μg/L.&#xD;
&#xD;
          -  Acceptation of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or contraindication to any of the drugs under study.&#xD;
&#xD;
          -  SpO2 &lt;90% (in air ambient) or PaO2 &lt;60 mmHg (in ambient air) or PaO2/FiO2 &lt;300 mmHg.&#xD;
&#xD;
          -  Ongoing treatment with glucocorticoids, immunosuppressive, or biologic drugs with&#xD;
             another indication.&#xD;
&#xD;
          -  Decompensated diabetes mellitus.&#xD;
&#xD;
          -  Uncontrolled hypertension.&#xD;
&#xD;
          -  Psychotic or manic disorder.&#xD;
&#xD;
          -  Active cancer.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Clinical or biochemical suspicion (procalcitonin &gt;0.5 ng/mL) of active infection other&#xD;
             than SARS-CoV-2.&#xD;
&#xD;
          -  Out-of-hospital management patient.&#xD;
&#xD;
          -  Conservative or palliative management patient.&#xD;
&#xD;
          -  Participation in another clinical trial.&#xD;
&#xD;
          -  Any important and uncontrolled medical, psychological, psychiatric, geographic or&#xD;
             social problem that contraindicates the patient's participation in the trial or that&#xD;
             does not allow adequate follow-up and adherence to the protocol and evaluation of the&#xD;
             study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Iñigo Les Bujanda, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Complejo Hospitalario de Navarra</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Sant Joan Despí Moisès Broggi</name>
      <address>
        <city>Sant Joan Despí</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>May 14, 2021</last_update_submitted>
  <last_update_submitted_qc>May 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Covid-19</keyword>
  <keyword>pneumonia</keyword>
  <keyword>Inflammatory phase</keyword>
  <keyword>Glucocorticoids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected IPD will be available for exploitation in future research projects. This statement also includes the availability of the study protocol, the statistical analysis plan, the informed consent form, the clinical study report and the analytic code.</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/NCT04438980
org study id: CORTIVID
nct id: NCT04438980
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state
      whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the
      early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this
      setting remains controversial. This study aims to assess the safety and effectiveness of GC
      pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen
      inflammatory biomarkers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Proportion of patients developing treatment failure
time frame: At 14 days after randomization
description: • Death
measure: Proportion of patients developing treatment failure
time frame: At 14 days after randomization
description: • Need for admission in an intensive care unit (ICU)
measure: Proportion of patients developing treatment failure
time frame: At 14 days after randomization
description: • Need for mechanical ventilation
measure: Proportion of patients developing treatment failure
time frame: At 14 days after randomization
description: • Decrease in SpO2 <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2FiO2 <300 mmHg, associated with radiological impairment
measure: Mortality at day 28
time frame: At 28 days after randomization
measure: Proportion of patients requiring ICU admission
time frame: At 28 days after randomization
measure: Proportion of patients requiring rescue-therapy with tocilizumab
time frame: At 14 days after randomization
measure: Length of hospital stay
time frame: At 28 days after randomization
description: Time in days from randomization until the date of hospital discharge.
measure: Proportion of severe adverse events
time frame: At 28 days after randomization
description: Any undesirable experience related to the use of the studied drugs, which causes patient's death, life-threatening risk, hospitalization or extension of a previous hospitalization, disability or permanent damage, requires intervention to prevent permanent impairment or damage, or is considered medically relevant
measure: Proportion of bacterial, fungal or opportunistic infections
time frame: At 28 days after randomization
measure: Evolution of inflammatory biomarkers related to COVID-19
time frame: At 14 days after randomization
description: Change in plasma levels of C-reactive protein (CRP)
measure: Evolution of inflammatory biomarkers related to COVID-19
time frame: At 14 days after randomization
description: Change in plasma levels of ferritin
measure: Evolution of inflammatory biomarkers related to COVID-19
time frame: At 14 days after randomization
description: Change in plasma levels of interleukin-6 (IL-6)
measure: Evolution of inflammatory biomarkers related to COVID-19
time frame: At 14 days after randomization
description: Change in plasma levels of lactate dehydrogenase (LDH)
measure: Evolution of inflammatory biomarkers related to COVID-19
time frame: At 14 days after randomization
description: Change in plasma levels of D-dimer (DD)
measure: Proportion of SARS-CoV-2 clearance.
time frame: At 7 days after randomization
description: Negativization of RT-PCR for SARS-CoV-2 on nasopharyngeal swab or sputum
arm group label: Methylprednisolone Arm
arm group type: Experimental
description: Standard of care plus Methylprednisolone
arm group label: Placebo Arm
arm group type: Placebo Comparator
description: Standard of care plus placebo
intervention type: Drug
intervention name: Methylprednisolone
description: -A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión
arm group label: Methylprednisolone Arm
intervention type: Other
intervention name: Placebo
description: -An infusion bag of 100 mL of 0.9% saline
arm group label: Placebo Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Iñigo Les Bujanda, PhD
role: Principal Investigator
affiliation: Complejo Hospitalario de Navarra
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
sharing ipd: Yes
ipd description: All collected IPD will be available for exploitation in future research projects. This statement also includes the availability of the study protocol, the statistical analysis plan, the informed consent form, the clinical study report and the analytic code.