Rapid-Cycle Re-Implementation of TRAining Facilities in Norway

Training Clinical Trial

— TRAiN  

Official title:

Rapid-Cycle Re-Implementation of TRAining Facilities in Norway

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04406909
• Other study ID #: REK 143984
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 22, 2020
• Est. completion date: May 19, 2022

Study information

• Verified date: June 2020
• Source: Norwegian Department of Health and Social Affairs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Est. completion date: May 19, 2022
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Training

Intervention

Other:
• Access to training facility
Access to training facility under national regulations for COVID control

Locations

Country	Name	City	State
Norway	SATS Training	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian Department of Health and Social Affairs

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 RNA test positivity	Percentage of COVID-19 RNA positive individuals	At the end of Cycle 1 (cycle length is 14 days)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)