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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04406909
Other study ID # REK 143984
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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