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Rapid-Cycle Re-Implementation of TRAining Facilities in Norway

NCT04406909 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2020-06-23

No results posted yet for this study

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.

Conditions

  • Training

Interventions

OTHER

Access to training facility

Access to training facility under national regulations for COVID control

Sponsors & Collaborators

  • Norwegian Department of Health and Social Affairs

    lead OTHER_GOV

Principal Investigators

  • Magnus Løberg, MD PhD · University of Oslo

  • Mette Kalager, MD PhD · University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-22
Primary Completion
2021-05-19
Completion
2022-05-19

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04406909 on ClinicalTrials.gov