- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Oslo, Norge, 0218
- SATS Training
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Training
Access to training at membership training facility
|
Access to training facility under national regulations for COVID control
|
Ingen indgriben: No training
No access to training at membership training facility
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
COVID-19 RNA test positivity
Tidsramme: At the end of Cycle 1 (cycle length is 14 days)
|
Percentage of COVID-19 RNA positive individuals
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At the end of Cycle 1 (cycle length is 14 days)
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Hospital admission for COVID-19
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
individuals with COVID-19 antibodies
Tidsramme: 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
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14 to 20 days after the end of Cycle 1 (cycle length is 14 days)
|
Percentage of individuals with health care contacts
Tidsramme: 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
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7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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Need of ventilator treatment after hospital admission for COVID-19
Tidsramme: 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)
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ICU admission for COVID-19
Tidsramme: 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
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7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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Cause-specific death
Tidsramme: 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)
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7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
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COVID-19 RNA test positivity in employees at training centres
Tidsramme: At the end of Cycle 1 (cycle length is 14 days)
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Percentage of COVID-19 RNA positive employees who worked at the training centres during the intervention
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At the end of Cycle 1 (cycle length is 14 days)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Magnus Løberg, MD PhD, University of Oslo
- Ledende efterforsker: Mette Kalager, MD PhD, University of Oslo
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- REK 143984
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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