<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/NCT04451174</url>
  </required_header>
  <id_info>
    <org_study_id>2092</org_study_id>
    <nct_id>NCT04451174</nct_id>
  </id_info>
  <brief_title>Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia</brief_title>
  <acronym>PREDCOVID</acronym>
  <official_title>Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chile</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>
      Steroids has shown benefits in COVID19 patients in observational studies. We hypothesized&#xD;
      that early use of corticosteroids, low dose, in mild disease, can decrease progression to&#xD;
      respiratory failure and death.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We are in the middle of a coronavirus pandemic, facing a large number of infections in&#xD;
      serious cases and an increasing number of deaths in Chile. As of June 11, 2020, there are&#xD;
      154092 cases confirmed by COVID - 19 i and 2648 deaths in our country.&#xD;
&#xD;
      Most patients have mild disease, but older people and those with comorbidities can develop&#xD;
      severe disease that requires hospitalization, some form of ventilatory support, and&#xD;
      eventually intensive care unit admission. The pathophysiology occurs in two different&#xD;
      overlapping phases, the initial pathogen with viral replication, followed by the host's&#xD;
      inflammatory response with varying degrees of severity associated with different clinical&#xD;
      characteristics. The pathological progression in some cases of severe COVID-19 would be&#xD;
      explained by an excess of proinflammatory cytokines, which leads to diffuse alveolar damage,&#xD;
      with the development of acute respiratory distress syndrome (ARDS) and inflammatory&#xD;
      compromise of multiple systems until death.&#xD;
&#xD;
      In the absence of any proven antiviral therapy, current clinical treatment is primarily&#xD;
      supportive care, supplemental oxygen, and mechanical ventilatory support.&#xD;
&#xD;
      Clinical trials have been published and called to demonstrate the usefulness of therapies in&#xD;
      the context of this pandemic.&#xD;
&#xD;
      The role of corticosteroids is not fully defined. Observational studies report better results&#xD;
      in decreasing disease progression in those COVID-19 patients who received corticosteroids&#xD;
      early.&#xD;
&#xD;
      We hypothesize in this study that treatment in mild disease (defined as that requiring&#xD;
      supplemental oxygen, but without the need for ventilatory support) can attenuate the host's&#xD;
      excessive respiratory and systemic inflammatory responses.&#xD;
&#xD;
      The objective of this study is to evaluate the effect of early treatment with prednisone to&#xD;
      decrease the progression of the disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Corticosteroid use approval&#xD;
  </why_stopped>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Actual">January 30, 2021</completion_date>
  <primary_completion_date type="Actual">January 30, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Prednisone 40 mg days 1 to 4. Then, prednisone 20 mg days 5 to 8.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or more&#xD;
&#xD;
          -  COVID-19 confirmed by PCR&#xD;
&#xD;
          -  Oxygen requirements until 35 % by venturi mask or 5 lt minutes by nasal cannula&#xD;
&#xD;
          -  Consent form signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous steroid use 48 hours or more.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Chronic respiratory failure&#xD;
&#xD;
          -  Requirements of mechanical ventilation (invasive or no invasive)&#xD;
&#xD;
          -  Chronic liver damage Child Pugh B or C&#xD;
&#xD;
          -  Chronic kidney disease stage IV or V.&#xD;
&#xD;
          -  Immunosuppressed&#xD;
&#xD;
          -  Participation on other trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mauricio Salinas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chile</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Santiago Oriente</name>
      <address>
        <city>Santiago</city>
        <state>Peñalolen</state>
        <zip>7930124</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>May 30, 2021</last_update_submitted>
  <last_update_submitted_qc>May 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>Mauricio Salinas</investigator_full_name>
    <investigator_title>Mauricio Salinas MD</investigator_title>
  </responsible_party>
  <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>Prednisone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>starting 6 months after publication</ipd_time_frame>
  </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/NCT04451174
org study id: 2092
nct id: NCT04451174
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Steroids has shown benefits in COVID19 patients in observational studies. We hypothesized
      that early use of corticosteroids, low dose, in mild disease, can decrease progression to
      respiratory failure and death.
We are in the middle of a coronavirus pandemic, facing a large number of infections in
      serious cases and an increasing number of deaths in Chile. As of June 11, 2020, there are
      154092 cases confirmed by COVID - 19 i and 2648 deaths in our country.

      Most patients have mild disease, but older people and those with comorbidities can develop
      severe disease that requires hospitalization, some form of ventilatory support, and
      eventually intensive care unit admission. The pathophysiology occurs in two different
      overlapping phases, the initial pathogen with viral replication, followed by the host's
      inflammatory response with varying degrees of severity associated with different clinical
      characteristics. The pathological progression in some cases of severe COVID-19 would be
      explained by an excess of proinflammatory cytokines, which leads to diffuse alveolar damage,
      with the development of acute respiratory distress syndrome (ARDS) and inflammatory
      compromise of multiple systems until death.

      In the absence of any proven antiviral therapy, current clinical treatment is primarily
      supportive care, supplemental oxygen, and mechanical ventilatory support.

      Clinical trials have been published and called to demonstrate the usefulness of therapies in
      the context of this pandemic.

      The role of corticosteroids is not fully defined. Observational studies report better results
      in decreasing disease progression in those COVID-19 patients who received corticosteroids
      early.

      We hypothesize in this study that treatment in mild disease (defined as that requiring
      supplemental oxygen, but without the need for ventilatory support) can attenuate the host's
      excessive respiratory and systemic inflammatory responses.

      The objective of this study is to evaluate the effect of early treatment with prednisone to
      decrease the progression of the disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28
time frame: 28 days
arm group label: Treatment
arm group type: Experimental
description: Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8.
arm group label: Control
arm group type: No Intervention
intervention type: Drug
intervention name: Prednisone
description: Prednisone 40 mg days 1 to 4. Then, prednisone 20 mg days 5 to 8.
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Mauricio Salinas, MD
role: Principal Investigator
affiliation: University of Chile
facility: 
country: Chile
responsible party type: Principal Investigator
investigator affiliation: University of Chile
investigator full name: Mauricio Salinas
investigator title: Mauricio Salinas MD
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Prednisone
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: starting 6 months after publication