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Rapid-Cycle Re-Implementation of TRAining Facilities in Norway (TRAiN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04406909
Recruitment Status : Active, not recruiting
First Posted : May 29, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Bretthauer, University of Oslo

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Training Other: Access to training facility Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Rapid-Cycle Re-Implementation of TRAining Facilities in Norway
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : May 19, 2021
Estimated Study Completion Date : May 19, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Training
Access to training at membership training facility
 Other: Access to training facility
Access to training facility under national regulations for COVID control
No Intervention: No training
No access to training at membership training facility


Outcome Measures
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Primary Outcome Measures :
  1. COVID-19 RNA test positivity [ Time Frame: At the end of Cycle 1 (cycle length is 14 days) ]
    Percentage of COVID-19 RNA positive individuals

  2. Hospital admission for COVID-19 [ Time Frame: 7 days after the end of Cycle 1 (cycle length is 14 days) ]
    Percentage of people admitted to hospital for COVID-19


Secondary Outcome Measures :
  1. individuals with COVID-19 antibodies [ Time Frame: 14 to 20 days after the end of Cycle 1 (cycle length is 14 days) ]
    Percentage of individuals with COVID-19 antibodies by blood sampling

  2. 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) ]
    Percentage of people who had any contacs with primary or secondary health care services

  3. 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) ]
    Percentage of people in need of ventilator after hosital admission for COVID-19

  4. ICU admission for COVID-19 [ Time Frame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days) ]
    Percentage of people admitted to the ICU for COVID-19

  5. Cause-specific death [ Time Frame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days) ]
    Percentage of people who died, with cause of death (including underlying cause of death)

  6. COVID-19 RNA test positivity in employees at training centres [ Time Frame: At the end of Cycle 1 (cycle length is 14 days) ]
    Percentage of COVID-19 RNA positive employees who worked at the training centres during the intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all members of participating training facilities age 18 years or older who are not at increased risk for severe COVID-19 disease (see www.fhi.no for criteria) are eligible for participation if they

    • plan to use the training facility regularly during the project period
    • are willing to adhere to training policies during the project
    • accept assessment of project endpoints
    • approve handling of data for the project

Exclusion Criteria:

  • COVId-19 related comorbidity
  • Age below 18 years or above 64 years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406909


Locations
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Norway
SATS Training
Oslo, Norway, 0218
Sponsors and Collaborators
Norwegian Department of Health and Social Affairs
Investigators
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Principal Investigator: Magnus Løberg, MD PhD University of Oslo
Principal Investigator: Mette Kalager, MD PhD University of Oslo
More Information
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Responsible Party: Michael Bretthauer, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT04406909    
Other Study ID Numbers: REK 143984
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No