<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/NCT04406909</url>
  </required_header>
  <id_info>
    <org_study_id>REK 143984</org_study_id>
    <nct_id>NCT04406909</nct_id>
  </id_info>
  <brief_title>Rapid-Cycle Re-Implementation of TRAining Facilities in Norway</brief_title>
  <acronym>TRAiN</acronym>
  <official_title>Rapid-Cycle Re-Implementation of TRAining Facilities in Norway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian Department of Health and Social Affairs</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norwegian Department of Health and Social Affairs</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study tests the randomized re-opening of training facilities in Norway in relation to&#xD;
      the COVID-19 pandemic. The investigators will use the recently developed concept of&#xD;
      rapid-cycle randomized implementation to assure fast and safe re-introduction of training&#xD;
      facilities by randomized testing of access restriction and measure virus exposure and&#xD;
      immunity as well as clinical disease during the intervention to enable safe and timely&#xD;
      downgrading of COVID-19 restrictions.&#xD;
&#xD;
      Members of training facilities in Norway age 18 to 64 years without COVID-19 related&#xD;
      comorbidity will after informed consent be randomised to either access to training or no&#xD;
      access in a first 2-week cycle. Testing for COVID-19 and ascertainment of clinical disease&#xD;
      will be performed after the first cycle. If there is no clinically meaningful difference&#xD;
      between the arms, new cycles may be implemented subsequently, e.g. with less distancing&#xD;
      restrictions or wider age groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 22, 2020</start_date>
  <completion_date type="Anticipated">May 19, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 19, 2021</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>COVID-19 RNA test positivity</measure>
    <time_frame>At the end of Cycle 1 (cycle length is 14 days)</time_frame>
    <description>Percentage of COVID-19 RNA positive individuals</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital admission for COVID-19</measure>
    <time_frame>7 days after the end of Cycle 1 (cycle length is 14 days)</time_frame>
    <description>Percentage of people admitted to hospital for COVID-19</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>individuals with COVID-19 antibodies</measure>
    <time_frame>14 to 20 days after the end of Cycle 1 (cycle length is 14 days)</time_frame>
    <description>Percentage of individuals with COVID-19 antibodies by blood sampling</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of individuals with health care contacts</measure>
    <time_frame>7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)</time_frame>
    <description>Percentage of people who had any contacs with primary or secondary health care services</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need of ventilator treatment after hospital admission for COVID-19</measure>
    <time_frame>7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)</time_frame>
    <description>Percentage of people in need of ventilator after hosital admission for COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU admission for COVID-19</measure>
    <time_frame>7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)</time_frame>
    <description>Percentage of people admitted to the ICU for COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cause-specific death</measure>
    <time_frame>7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)</time_frame>
    <description>Percentage of people who died, with cause of death (including underlying cause of death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID-19 RNA test positivity in employees at training centres</measure>
    <time_frame>At the end of Cycle 1 (cycle length is 14 days)</time_frame>
    <description>Percentage of COVID-19 RNA positive employees who worked at the training centres during the intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4000</enrollment>
  <condition>Training</condition>
  <arm_group>
    <arm_group_label>Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Access to training at membership training facility</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No training</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No access to training at membership training facility</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Access to training facility</intervention_name>
    <description>Access to training facility under national regulations for COVID control</description>
    <arm_group_label>Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all members of participating training facilities age 18 years or older who are not at&#xD;
             increased risk for severe COVID-19 disease (see www.fhi.no for criteria) are eligible&#xD;
             for participation if they&#xD;
&#xD;
               -  plan to use the training facility regularly during the project period&#xD;
&#xD;
               -  are willing to adhere to training policies during the project&#xD;
&#xD;
               -  accept assessment of project endpoints&#xD;
&#xD;
               -  approve handling of data for the project&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  COVId-19 related comorbidity&#xD;
&#xD;
          -  Age below 18 years or above 64 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magnus Løberg, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mette Kalager, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SATS Training</name>
      <address>
        <city>Oslo</city>
        <zip>0218</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>June 21, 2020</last_update_submitted>
  <last_update_submitted_qc>June 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Michael Bretthauer</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04406909
org study id: REK 143984
nct id: NCT04406909
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study tests the randomized re-opening of training facilities in Norway in relation to
      the COVID-19 pandemic. The investigators will use the recently developed concept of
      rapid-cycle randomized implementation to assure fast and safe re-introduction of training
      facilities by randomized testing of access restriction and measure virus exposure and
      immunity as well as clinical disease during the intervention to enable safe and timely
      downgrading of COVID-19 restrictions.

      Members of training facilities in Norway age 18 to 64 years without COVID-19 related
      comorbidity will after informed consent be randomised to either access to training or no
      access in a first 2-week cycle. Testing for COVID-19 and ascertainment of clinical disease
      will be performed after the first cycle. If there is no clinically meaningful difference
      between the arms, new cycles may be implemented subsequently, e.g. with less distancing
      restrictions or wider age groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: COVID-19 RNA test positivity
time frame: At the end of Cycle 1 (cycle length is 14 days)
description: Percentage of COVID-19 RNA positive individuals
measure: Hospital admission for COVID-19
time frame: 7 days after the end of Cycle 1 (cycle length is 14 days)
description: Percentage of people admitted to hospital for COVID-19
measure: individuals with COVID-19 antibodies
time frame: 14 to 20 days after the end of Cycle 1 (cycle length is 14 days)
description: Percentage of individuals with COVID-19 antibodies by blood sampling
measure: Percentage of individuals with health care contacts
time frame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
description: Percentage of people who had any contacs with primary or secondary health care services
measure: Need of ventilator treatment after hospital admission for COVID-19
time frame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
description: Percentage of people in need of ventilator after hosital admission for COVID-19
measure: ICU admission for COVID-19
time frame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
description: Percentage of people admitted to the ICU for COVID-19
measure: Cause-specific death
time frame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
description: Percentage of people who died, with cause of death (including underlying cause of death)
measure: COVID-19 RNA test positivity in employees at training centres
time frame: At the end of Cycle 1 (cycle length is 14 days)
description: Percentage of COVID-19 RNA positive employees who worked at the training centres during the intervention
arm group label: Training
arm group type: Experimental
description: Access to training at membership training facility
arm group label: No training
arm group type: No Intervention
description: No access to training at membership training facility
intervention type: Other
intervention name: Access to training facility
description: Access to training facility under national regulations for COVID control
arm group label: Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Magnus Løberg, MD PhD
role: Principal Investigator
affiliation: University of Oslo
last name: Mette Kalager, MD PhD
role: Principal Investigator
affiliation: University of Oslo
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Michael Bretthauer
investigator title: Professor
sharing ipd: No