Training
Conditions
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.
Interventions
OTHERAccess to training facility
Access to training facility under national regulations for COVID control
Sponsors
Norwegian Department of Health and Social Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 RNA test positivity | At the end of Cycle 1 (cycle length is 14 days) | Percentage of COVID-19 RNA positive individuals |
| Hospital admission for COVID-19 | 7 days after the end of Cycle 1 (cycle length is 14 days) | Percentage of people admitted to hospital for COVID-19 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need of ventilator treatment after hospital admission for COVID-19 | 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 |
| ICU admission for COVID-19 | 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 |
| individuals with COVID-19 antibodies | 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 |
| COVID-19 RNA test positivity in employees at training centres | 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 |
| Cause-specific death | 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) |
| Percentage of individuals with health care contacts | 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 |
Countries
Norway
Outcome results
None listed