<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/NCT04470544</url>
  </required_header>
  <id_info>
    <org_study_id>CAM20CV</org_study_id>
    <nct_id>NCT04470544</nct_id>
  </id_info>
  <brief_title>Camostat Mesilate Treating Patients With Hospitalized Patients With COVID-19</brief_title>
  <acronym>RECOVER</acronym>
  <official_title>RECOVER: Phase 2 Randomized, Double-Blind Trial TREating Hospitalized Patients With COVID-19 With Camostat MesilatE, a TMPRSS2 Inhibitor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alan Bryce</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academic and Community Cancer Research United</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat&#xD;
      mesilate combined with standard of care (SOC) treatment will increase the proportion of&#xD;
      patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC&#xD;
      treatment with placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Anticipated">September 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the proportion of patients alive and free from respiratory failure</measure>
    <time_frame>28 Days</time_frame>
    <description>To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will change the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the proportion of patients alive and free of ventilator use or ECMO</measure>
    <time_frame>28 Days</time_frame>
    <description>To determine if reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with SOC treatment will change the proportion of patients alive and free of ventilator use or ECMO at Day 28 as compared to SOC treatment combined with placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality Rate</measure>
    <time_frame>28 and 56 Days</time_frame>
    <description>To determine if the combination of Camostat mesilate combined with SOC treatment will result in a changed mortality rate at 28 and 56 days as compared to SOC treatment combined with placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Change</measure>
    <time_frame>14 and 28 Days</time_frame>
    <description>Clinical change will be defined as a 2 or more point decease on the WHO ordinal scale. Time to clinical improvement will be calculated as the number of days from study entry until the earliest date of clinical change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>up to 56 days</time_frame>
    <description>Analyses for safety will include all participants who are randomized and received at least 1 dose of study treatment. Participants will be grouped according to the treatment to which they were randomized.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">264</enrollment>
  <condition>Severe Acute Respiratory Syndrome</condition>
  <arm_group>
    <arm_group_label>Placebo + Standard of Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Camostat + Standard of Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Camostat Mesilate</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Camostat + Standard of Care</arm_group_label>
    <other_name>Foipan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>At Investigator discretion</description>
    <arm_group_label>Placebo + Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Laboratory confirmed SARS-CoV-2 infection&#xD;
&#xD;
          -  Admitted to hospital for management of SARS-CoV-2&#xD;
&#xD;
          -  Age ≥18&#xD;
&#xD;
          -  Subject or legal representative able to give informed consent&#xD;
&#xD;
          -  Ability to take all study drugs&#xD;
&#xD;
          -  Respiratory status of 3 or greater on the WHO ordinal scale&#xD;
&#xD;
          -  ALT or AST ≤5 x ULN&#xD;
&#xD;
          -  Creatinine clearance ≥50 mL/min using the Cockroft-Gault formula&#xD;
&#xD;
          -  Willingness to provide mandatory specimens for correlative research and banking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding&#xD;
&#xD;
          -  Known hypersensitivity to the study drug, the metabolites or formulation excipient&#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>Alan H Bryce, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academic and Community Cancer Research United</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vy Nguyen</last_name>
      <phone>480-342-1328</phone>
      <email>Nguyen.Vy@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Alan H Bryce, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tucson Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalia Elias Calles</last_name>
      <phone>520-324-5512</phone>
      <email>ClinicalResearch@tmcaz.com</email>
    </contact>
    <investigator>
      <last_name>Robert Aaronson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Torsak Vimoktayon</last_name>
      <phone>904-953-3238</phone>
      <email>Vimoktayon.Torsak@mayo.edu</email>
    </contact>
    <contact_backup>
      <last_name>Stacey Pecenka</last_name>
      <phone>904-953-4261</phone>
      <email>Pecenka.Stacey@mayo.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Sadia Shah, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 9, 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>January 7, 2021</last_update_submitted>
  <last_update_submitted_qc>January 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Academic and Community Cancer Research United</investigator_affiliation>
    <investigator_full_name>Alan Bryce</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>Severe Acute Respiratory Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Camostat</mesh_term>
  </intervention_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/NCT04470544
org study id: CAM20CV
nct id: NCT04470544
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat
      mesilate combined with standard of care (SOC) treatment will increase the proportion of
      patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC
      treatment with placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in the proportion of patients alive and free from respiratory failure
time frame: 28 Days
description: To determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will change the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.
measure: Change in the proportion of patients alive and free of ventilator use or ECMO
time frame: 28 Days
description: To determine if reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with SOC treatment will change the proportion of patients alive and free of ventilator use or ECMO at Day 28 as compared to SOC treatment combined with placebo.
measure: Mortality Rate
time frame: 28 and 56 Days
description: To determine if the combination of Camostat mesilate combined with SOC treatment will result in a changed mortality rate at 28 and 56 days as compared to SOC treatment combined with placebo.
measure: Clinical Change
time frame: 14 and 28 Days
description: Clinical change will be defined as a 2 or more point decease on the WHO ordinal scale. Time to clinical improvement will be calculated as the number of days from study entry until the earliest date of clinical change.
measure: Adverse Events
time frame: up to 56 days
description: Analyses for safety will include all participants who are randomized and received at least 1 dose of study treatment. Participants will be grouped according to the treatment to which they were randomized.
arm group label: Placebo + Standard of Care
arm group type: Placebo Comparator
description: Standard of Care will be defined by the investigators in collaboration with the sponsor on the basis of the best available evidence at the time of study initiation with placebo.
arm group label: Camostat + Standard of Care
arm group type: Experimental
description: Patient will receive SOC tablets and Camostat mesilate 200 mg four times a day after each meal with Standard of Care treatment.
intervention type: Drug
intervention name: Camostat Mesilate
description: Given PO
arm group label: Camostat + Standard of Care
other name: Foipan
intervention type: Other
intervention name: Standard of Care
description: At Investigator discretion
arm group label: Placebo + Standard of Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alan H Bryce, M.D.
role: Principal Investigator
affiliation: Academic and Community Cancer Research United
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Academic and Community Cancer Research United
investigator full name: Alan Bryce
investigator title: Principal Investigator
mesh term: Severe Acute Respiratory Syndrome
mesh term: Camostat