- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04406909
Rapid-Cycle Re-Implementation of TRAining Facilities in Norway (TRAiN)
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0218
- SATS Training
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training
Access to training at membership training facility
|
Access to training facility under national regulations for COVID control
|
No Intervention: No training
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
Time Frame: At the end of Cycle 1 (cycle length is 14 days)
|
Percentage of COVID-19 RNA positive individuals
|
At the end of Cycle 1 (cycle length is 14 days)
|
Hospital admission for COVID-19
Time Frame: 7 days after the end of Cycle 1 (cycle length is 14 days)
|
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
Time Frame: 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
|
14 to 20 days after the end of Cycle 1 (cycle length is 14 days)
|
Percentage of individuals with health care contacts
Time Frame: 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
|
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
Time Frame: 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
|
7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
|
ICU admission for COVID-19
Time Frame: 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
|
7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
|
Cause-specific death
Time Frame: 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)
|
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
Time Frame: 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
|
At the end of Cycle 1 (cycle length is 14 days)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Magnus Løberg, MD PhD, University of Oslo
- Principal Investigator: Mette Kalager, MD PhD, University of Oslo
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REK 143984
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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