<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/NCT04493359</url>
  </required_header>
  <id_info>
    <org_study_id>33575220.9.0000.0068</org_study_id>
    <nct_id>NCT04493359</nct_id>
  </id_info>
  <brief_title>Switch of Renin-Angiotensin System Inhibitors in Patients With Covid-19</brief_title>
  <acronym>SWITCH-COVID</acronym>
  <official_title>Switch or Maintenance of Renin-Angiotensin System Inhibitors in Patients With Covid-19: A Randomized Proof of Concept Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The SWITCH-COVID trial will randomize patients with COVID-19 that are currently using&#xD;
      renin-angiotensin system inhibitors for treating hypertension to maintain the therapy during&#xD;
      in-hospital stay or switch the therapy to other antihypertensive classes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients eligible for the study, after signing informed consent will be randomized 1:1 for&#xD;
      maintenance of renin-angiotensin system inhibitors or switching the antihypertensive therapy&#xD;
      for other classes according to a pre-specified protocol.&#xD;
&#xD;
      Patients are going to be followed during hospital stay for evaluation of clinical endpoints.&#xD;
      Also blood and urine samples will be acquired for evaluation of renin-angiotensin system&#xD;
      activation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Dificulteis in enrolling patients&#xD;
  </why_stopped>
  <start_date type="Actual">July 25, 2020</start_date>
  <completion_date type="Actual">September 28, 2021</completion_date>
  <primary_completion_date type="Actual">September 28, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Need for ICU or mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Combined of need for ICU or mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>High sensitivity troponin levels and covid-19 severity</measure>
    <time_frame>30 days</time_frame>
    <description>Evaluate correlation between hs-TnT and covid-19 severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACE-2 activity and disease severity</measure>
    <time_frame>30 days</time_frame>
    <description>Evaluate correlation of ACE-2 activity and disease severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACE-2 activity with different Renin-angiotensin system inhibitors</measure>
    <time_frame>30 days</time_frame>
    <description>Evaluate correlation of ACE-2 activity and Renin-angiotensin system inhibitors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood control and acute renal failure</measure>
    <time_frame>30 days</time_frame>
    <description>Evaluate blood pressure control and acute renal failure in each arm (safety)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Covid19</condition>
  <condition>Angiotensin II Receptor Antagonist Adverse Reaction</condition>
  <arm_group>
    <arm_group_label>Switch therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Renin-angiotensin system inhibitors will be changed for other anti-hypertensive classes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance therapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Renin-angiotensin system inhibitors will be kept during in-hospital stay</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Renin-angiotensin system inhibitors</intervention_name>
    <description>switch anti-hypertensive class</description>
    <arm_group_label>Switch therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypertension in use of renin-angiotensin system inhibitors&#xD;
&#xD;
          -  Confirmed COVID-19 infection by rt-PCR, serology tests or typical clinical&#xD;
             presentation and chest CT.&#xD;
&#xD;
          -  Symptoms onset &lt; 96h&#xD;
&#xD;
          -  Need for hospitalization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Heart failure&#xD;
&#xD;
          -  Previous cerebrovascular disease&#xD;
&#xD;
          -  Previous myocardial infarction&#xD;
&#xD;
          -  Blood pressure &gt; 180 x 100 mmHg&#xD;
&#xD;
          -  Need for 3 or more anti-hypertensive classes&#xD;
&#xD;
          -  Use os spironolactone&#xD;
&#xD;
          -  Severe pulmonary disease&#xD;
&#xD;
          -  Contraindication for using other anti-hypertensive classes (calcium channel blockers,&#xD;
             hydralazine, diuretics or nitrates)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Instituto do Coração - Incor HCFMUSP</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>05403-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Bruno Caramelli</investigator_full_name>
    <investigator_title>MD. PHD.</investigator_title>
  </responsible_party>
  <keyword>covid19</keyword>
  <keyword>ace inhibitors</keyword>
  <keyword>ace2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data may be requested for collaboration projects</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/NCT04493359
org study id: 33575220.9.0000.0068
nct id: NCT04493359
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The SWITCH-COVID trial will randomize patients with COVID-19 that are currently using
      renin-angiotensin system inhibitors for treating hypertension to maintain the therapy during
      in-hospital stay or switch the therapy to other antihypertensive classes.
Patients eligible for the study, after signing informed consent will be randomized 1:1 for
      maintenance of renin-angiotensin system inhibitors or switching the antihypertensive therapy
      for other classes according to a pre-specified protocol.

      Patients are going to be followed during hospital stay for evaluation of clinical endpoints.
      Also blood and urine samples will be acquired for evaluation of renin-angiotensin system
      activation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Need for ICU or mortality
time frame: 30 days
description: Combined of need for ICU or mortality
measure: High sensitivity troponin levels and covid-19 severity
time frame: 30 days
description: Evaluate correlation between hs-TnT and covid-19 severity
measure: ACE-2 activity and disease severity
time frame: 30 days
description: Evaluate correlation of ACE-2 activity and disease severity
measure: ACE-2 activity with different Renin-angiotensin system inhibitors
time frame: 30 days
description: Evaluate correlation of ACE-2 activity and Renin-angiotensin system inhibitors
measure: Blood control and acute renal failure
time frame: 30 days
description: Evaluate blood pressure control and acute renal failure in each arm (safety)
arm group label: Switch therapy
arm group type: Experimental
description: Renin-angiotensin system inhibitors will be changed for other anti-hypertensive classes.
arm group label: Maintenance therapy
arm group type: No Intervention
description: Renin-angiotensin system inhibitors will be kept during in-hospital stay
intervention type: Drug
intervention name: Renin-angiotensin system inhibitors
description: switch anti-hypertensive class
arm group label: Switch therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Bruno Caramelli
investigator title: MD. PHD.
mesh term: COVID-19
sharing ipd: Undecided
ipd description: Data may be requested for collaboration projects