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

June 21, 2020 updated by: Michael Bretthauer, Norwegian Department of Health and Social Affairs

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway, 0218
        • SATS Training

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training
Access to training at membership training facility
Access to training facility under national regulations for COVID control
No Intervention: No training
No access to training at membership training facility

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of Cycle 1 (cycle length is 14 days)
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
7 days after the end of Cycle 1 (cycle length is 14 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 to 20 days after the end of Cycle 1 (cycle length is 14 days)
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
7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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
7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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
7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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)
7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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
At the end of Cycle 1 (cycle length is 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Magnus Løberg, MD PhD, University of Oslo
  • Principal Investigator: Mette Kalager, MD PhD, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2020

Primary Completion (Anticipated)

May 19, 2021

Study Completion (Anticipated)

May 19, 2022

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 21, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • REK 143984

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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