Clinical trial NCT04406909: Rapid-Cycle Re-Implementation of TRAining Facilities in Norway
Official title: Rapid-Cycle Re-Implementation of TRAining Facilities in Norway
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Training
Lead sponsor: Norwegian Department of Health and Social Affairs
Sponsor class: OTHER_GOV
First posted: 2020-05-29
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: COVID-19 RNA test positivity
timeFrame: At the end of Cycle 1 (cycle length is 14 days)
measure: Hospital admission for COVID-19
timeFrame: 7 days after the end of Cycle 1 (cycle length is 14 days)
Secondary outcomes:
measure: individuals with COVID-19 antibodies
timeFrame: 14 to 20 days after the end of Cycle 1 (cycle length is 14 days)
measure: Percentage of individuals with health care contacts
timeFrame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
measure: Need of ventilator treatment after hospital admission for COVID-19
timeFrame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
measure: ICU admission for COVID-19
timeFrame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
measure: Cause-specific death
timeFrame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
measure: COVID-19 RNA test positivity in employees at training centres
timeFrame: At the end of Cycle 1 (cycle length is 14 days)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: SATS Training
Study officials:
affiliation: University of Oslo
name: Magnus Løberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Mette Kalager, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Helsingen LM, Loberg M, Refsum E, Gjostein DK, Wieszczy P, Olsvik O, Juul FE, Barua I, Jodal HC, Herfindal M, Mori Y, Jore S, Lund-Johansen F, Fretheim A, Bretthauer M, Kalager M; TRAiN study group. Covid-19 transmission in fitness centers in Norway - a randomized trial. BMC Public Health. 2021 Nov 16;21(1):2103. doi: 10.1186/s12889-021-12073-0.