<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/NCT04409327</url>
  </required_header>
  <id_info>
    <org_study_id>RTB101-210</org_study_id>
    <nct_id>NCT04409327</nct_id>
  </id_info>
  <brief_title>Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes</brief_title>
  <official_title>Randomized Double Blind Placebo-Controlled Study to Determine if Prophylaxis With RTB101 Compared to Placebo Reduces Severity of Lab Confirmed COVID19 in Adults ≥65 Years in a Nursing Home in Which ≥1 Person(s) Have Lab Confirmed COVID19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Restorbio Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Restorbio Inc.</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>
      The purpose of this study is to determine if prophylaxis with RTB101 decreases the severity&#xD;
      of laboratory-confirmed COVID-19 among adults ≥ 65 years who reside in a nursing homes in&#xD;
      which one or more residents or staff have laboratory-confirmed COVID-19&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RTB101-210 is Placebo-Controlled Study to Determine if Prophylaxis with RTB101 as Compared to&#xD;
      Placebo Reduces the Severity of Laboratory-Confirmed COVID-19 in Adults Age ≥65 Years who&#xD;
      Reside in a Nursing Home in which One or More Residents or Staff have Laboratory-Confirmed&#xD;
      COVID-19. This trial is being conducted in follow up to a Phase 3 trial, in which trends&#xD;
      toward a reduction in the severity of laboratory-confirmed RTIs including coronavirus RTIs&#xD;
      were again seen. Therefore, RTB101 is a potential pan antiviral immunotherapy that may&#xD;
      prevent or ameliorate viral RTIs, including COVID-19, in older adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Insufficient accrual rate&#xD;
  </why_stopped>
  <start_date type="Actual">July 11, 2020</start_date>
  <completion_date type="Actual">January 24, 2021</completion_date>
  <primary_completion_date type="Actual">December 27, 2020</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die</measure>
    <time_frame>Through Week 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of subjects who develop symptomatic laboratory-confirmed COVID-19 infection</measure>
    <time_frame>Through Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate in subjects who develop laboratory-confirmed COVID19</measure>
    <time_frame>Through Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of subjects who are hospitalized due to having one or more predefined COVID-19 symptoms and laboratory-confirmed SARS-CoV-2</measure>
    <time_frame>Through Week 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of subjects who require mechanical ventilation, noninvasive ventilation, high flow nasal canula oxygen delivery or ICU admission during the hospitalization for COVID19</measure>
    <time_frame>Through Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability will be assessed by report of AE/SAEs</measure>
    <time_frame>Through Week 5 and 8</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>COVID19</condition>
  <arm_group>
    <arm_group_label>10 mg daily RTB101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TORC1 inhibitor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RTB101</intervention_name>
    <description>Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks</description>
    <arm_group_label>10 mg daily RTB101</arm_group_label>
    <other_name>Dactolisib</other_name>
    <other_name>BEZ235</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral matching placebo once daily for 4 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent must be obtained from the subject or health care proxy before any&#xD;
             assessment is performed.&#xD;
&#xD;
          -  Adults (male and female) aged 65 years and over.&#xD;
&#xD;
          -  Residing in a nursing home in which one or more residents or staff has developed&#xD;
             laboratory-confirmed symptomatic COVID-19 infection at the time of randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will not be eligible if they meet any of the following criteria:&#xD;
&#xD;
          -  Any subject who is a current smoker or has a ≥ 10 pack year smoking history.&#xD;
&#xD;
          -  Subjects with a medical history of chronic obstructive pulmonary disease (COPD).&#xD;
&#xD;
          -  Subjects who are in hospice or receiving comfort care only.&#xD;
&#xD;
          -  Subjects who have symptomatic laboratory-confirmed COVID-19 at the time of screening&#xD;
             or randomization.&#xD;
&#xD;
          -  Subjects with current evidence of an unstable medical disorder including an unstable&#xD;
             respiratory disorder, gastrointestinal disorder (including Child-Pugh class B and C&#xD;
             hepatic impairment), renal disorder (including subjects with an estimated glomerular&#xD;
             filtration rate (eGFR) ≤30 mL/min/1.73m2), or hematologic disorder (including active&#xD;
             leukemia).&#xD;
&#xD;
          -  Subjects receiving immunosuppressive therapy including chronic use of prednisone &gt;10&#xD;
             mg daily (however, inhaled corticosteroids and acute use of higher doses of prednisone&#xD;
             to treat conditions such as exacerbation of asthma or other acute conditions are&#xD;
             allowed).&#xD;
&#xD;
          -  Subjects with an immunodeficiency disease, including a positive human immunodeficiency&#xD;
             virus (HIV) test result.&#xD;
&#xD;
          -  Sexually active males with a partner of child-bearing potential&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Restorbio Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nursing Home</name>
      <address>
        <city>Middletown</city>
        <state>Rhode Island</state>
        <zip>02842</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>February 5, 2021</last_update_submitted>
  <last_update_submitted_qc>February 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mechanistic Target of Rapamycin (mTOR)</keyword>
  <keyword>Virus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dactolisib</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>June 1, 2021</submitted>
    <returned>June 7, 2021</returned>
  </pending_results>
  <!-- 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/NCT04409327
org study id: RTB101-210
nct id: NCT04409327
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine if prophylaxis with RTB101 decreases the severity
      of laboratory-confirmed COVID-19 among adults ≥ 65 years who reside in a nursing homes in
      which one or more residents or staff have laboratory-confirmed COVID-19
RTB101-210 is Placebo-Controlled Study to Determine if Prophylaxis with RTB101 as Compared to
      Placebo Reduces the Severity of Laboratory-Confirmed COVID-19 in Adults Age ≥65 Years who
      Reside in a Nursing Home in which One or More Residents or Staff have Laboratory-Confirmed
      COVID-19. This trial is being conducted in follow up to a Phase 3 trial, in which trends
      toward a reduction in the severity of laboratory-confirmed RTIs including coronavirus RTIs
      were again seen. Therefore, RTB101 is a potential pan antiviral immunotherapy that may
      prevent or ameliorate viral RTIs, including COVID-19, in older adults.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die
time frame: Through Week 4
measure: The percentage of subjects who develop symptomatic laboratory-confirmed COVID-19 infection
time frame: Through Week 4
measure: Mortality rate in subjects who develop laboratory-confirmed COVID19
time frame: Through Week 8
measure: Percent of subjects who are hospitalized due to having one or more predefined COVID-19 symptoms and laboratory-confirmed SARS-CoV-2
time frame: Through Week 4
measure: Percent of subjects who require mechanical ventilation, noninvasive ventilation, high flow nasal canula oxygen delivery or ICU admission during the hospitalization for COVID19
time frame: Through Week 8
measure: Safety and tolerability will be assessed by report of AE/SAEs
time frame: Through Week 5 and 8
arm group label: 10 mg daily RTB101
arm group type: Experimental
description: TORC1 inhibitor
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: RTB101
description: Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks
arm group label: 10 mg daily RTB101
other name: Dactolisib
other name: BEZ235
intervention type: Drug
intervention name: Placebo
description: Oral matching placebo once daily for 4 weeks
arm group label: Placebo
other name: Placebo capsule
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Restorbio Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Dactolisib
submitted: June 1, 2021
returned: June 7, 2021