Rapid-Cycle Re-Implementation of TRAining Facilities in Norway

Study Overview
=================
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.

Official Title
-----------------
Rapid-Cycle Re-Implementation of TRAining Facilities in Norway

Conditions
-----------------
Training

Intervention / Treatment
-----------------
* Other: Access to training facility


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training<br>Access to training at membership training facility | Other: Access to training facility<br>* Access to training facility under national regulations for COVID control<br>|
| No Intervention: No training<br>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 | Percentage of COVID-19 RNA positive individuals | At the end of Cycle 1 (cycle length is 14 days) | 
| Hospital admission for COVID-19 | 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 | 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 | 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 | 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 | 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 | 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 | 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) |