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Longitudinal Population-based Observational Study of COVID-19 in the UK Population (COVIDENCE UK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04330599
Recruitment Status : Active, not recruiting
First Posted : April 1, 2020
Last Update Posted : January 31, 2022
Sponsor:
Collaborators:
King's College London
London School of Hygiene and Tropical Medicine
University of Edinburgh
Swansea University
Queen's University, Belfast
Barts & The London NHS Trust
Information provided by (Responsible Party):
Queen Mary University of London

Study Description
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Brief Summary:

COVIDENCE UK is a population-based observational longitudinal study that has the following objectives:

  1. To determine risk factors for incident COVID-19 and for adverse outcomes of COVID-19 in the UK population
  2. To characterise the natural history of COVID-19 in the UK population
  3. To evaluate the impact of COVID-19 on the physical and mental health of the UK population
  4. To provide a resource from which to identify potential participants for future clinical trials, and to use data collected in COVIDENCE as comparison or control data for trial participants who have been randomised to receive one or more interventions.

Condition or disease
COVID-19

Study Design
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Study Type : Observational
Actual Enrollment : 13000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Population-based Observational Study of COVID-19 in the UK Population
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Incidence of confirmed COVID-19 [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Incidence of probable or suspected COVID-19 [ Time Frame: 5 years ]
  2. Incidence of COVID-19 requiring hospitalisation [ Time Frame: 5 years ]
  3. Incidence of COVID-19 requiring ventilatory support [ Time Frame: 5 years ]
  4. Incidence of fatal COVID-19 [ Time Frame: 5 years ]
  5. Symptom duration per COVID-19 episode [ Time Frame: 5 years ]
  6. Symptom severity per COVID-19 episode [ Time Frame: 5 years ]
  7. Incidence of seroconversion to SARS-CoV-2 [ Time Frame: 5 years ]
  8. Incidence of recurrent COVID-19 [ Time Frame: 5 years ]
  9. EQ-5D-3L health-related quality of life score [ Time Frame: 5 years ]
  10. Health care costs associated with incident COVID-19 [ Time Frame: 5 years ]
  11. Impact of the COVID-19 pandemic and the societal response on participants' financial status [ Time Frame: 5 years ]
  12. Incidence of COVID-19 on participant's physical health [ Time Frame: 5 years ]
  13. Impact of COVID-19 on participants' mental health [ Time Frame: 5 years ]
  14. Impact of COVID-19 on physical health of offspring born to participants during follow-up [ Time Frame: 5 years ]

Biospecimen Retention:   Samples Without DNA
Eluates from dried blood spots

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
UK residents aged 16 years or more
Criteria

Inclusion Criteria:

  • UK resident
  • Age ≥16 years

Exclusion Criteria: none

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04330599


Locations
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United Kingdom
Queen Mary University of London
London, County (optional), United Kingdom, E1 2AB
Sponsors and Collaborators
Queen Mary University of London
King's College London
London School of Hygiene and Tropical Medicine
University of Edinburgh
Swansea University
Queen's University, Belfast
Barts & The London NHS Trust
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT04330599    
Other Study ID Numbers: COVIDENCE UK
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: January 31, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases