Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04330599
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : October 30, 2020
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

Tracking Information
First Submitted Date March 31, 2020
First Posted Date April 1, 2020
Last Update Posted Date October 30, 2020
Actual Study Start Date May 1, 2020
Estimated Primary Completion Date April 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 21, 2020)
Incidence of confirmed COVID-19 [ Time Frame: 5 years ]
Original Primary Outcome Measures
 (submitted: March 31, 2020)
Incidence of suspected, probable or confirmed COVID-19 [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures
 (submitted: April 24, 2020)
  • Incidence of probable or suspected COVID-19 [ Time Frame: 5 years ]
  • Incidence of COVID-19 requiring hospitalisation [ Time Frame: 5 years ]
  • Incidence of COVID-19 requiring ventilatory support [ Time Frame: 5 years ]
  • Incidence of fatal COVID-19 [ Time Frame: 5 years ]
  • Symptom duration per COVID-19 episode [ Time Frame: 5 years ]
  • Symptom severity per COVID-19 episode [ Time Frame: 5 years ]
  • Incidence of seroconversion to SARS-CoV-2 [ Time Frame: 5 years ]
  • Incidence of recurrent COVID-19 [ Time Frame: 5 years ]
  • EQ-5D-3L health-related quality of life score [ Time Frame: 5 years ]
  • Health care costs associated with incident COVID-19 [ Time Frame: 5 years ]
  • Impact of the COVID-19 pandemic and the societal response on participants' financial status [ Time Frame: 5 years ]
  • Incidence of COVID-19 on participant's physical health [ Time Frame: 5 years ]
  • Impact of COVID-19 on participants' mental health [ Time Frame: 5 years ]
  • Impact of COVID-19 on physical health of offspring born to participants during follow-up [ Time Frame: 5 years ]
Original Secondary Outcome Measures
 (submitted: March 31, 2020)
  • Incidence of confirmed COVID-19 [ Time Frame: 5 years ]
  • Incidence of COVID-19 requiring hospitalisation [ Time Frame: 5 years ]
  • Incidence of COVID-19 requiring ventilatory support [ Time Frame: 5 years ]
  • Incidence of fatal COVID-19 [ Time Frame: 5 years ]
  • Symptom duration per COVID-19 episode [ Time Frame: 5 years ]
  • Symptom severity per COVID-19 episode [ Time Frame: 5 years ]
  • Incidence of seroconversion to SARS-CoV-2 [ Time Frame: 5 years ]
  • Incidence of recurrent COVID-19 [ Time Frame: 5 years ]
  • EQ-5D-3L health-related quality of life score [ Time Frame: 5 years ]
  • Health care costs associated with incident COVID-19 [ Time Frame: 5 years ]
  • Impact of COVID-19 on participants' financial status [ Time Frame: 5 years ]
  • Incidence of physical complications of COVID-19 [ Time Frame: 5 years ]
  • Impact of COVID-19 on participants' mental well-being [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Longitudinal Population-based Observational Study of COVID-19 in the UK Population
Official Title Longitudinal Population-based Observational Study of COVID-19 in the UK Population
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population UK residents aged 16 years or more
Condition COVID-19
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Holt H, Talaei M, Greenig M, Zenner D, Symons J, Relton C, Young KS, Davies MR, Thompson KN, Ashman J, Rajpoot SS, Kayyale AA, El Rifai S, Lloyd PJ, Jolliffe D, Timmis O, Finer S, Iliodromiti S, Miners A, Hopkinson NS, Alam B, Lloyd-Jones G, Dietrich T, Chapple I, Pfeffer PE, McCoy D, Davies G, Lyons RA, Griffiths C, Kee F, Sheikh A, Breen G, Shaheen SO, Martineau AR. Risk factors for developing COVID-19: a population-based longitudinal study (COVIDENCE UK). Thorax. 2021 Nov 30. pii: thoraxjnl-2021-217487. doi: 10.1136/thoraxjnl-2021-217487. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 31, 2020)
12000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2025
Estimated Primary Completion Date April 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • UK resident
  • Age ≥16 years

Exclusion Criteria: none

Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Adrian Martineau, PhD +442078822551 a.martineau@qmul.ac.uk
Contact: Hayley Holt, MSc h.holt@qmul.ac.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04330599
Other Study ID Numbers COVIDENCE UK
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Queen Mary University of London
Study Sponsor Queen Mary University of London
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
Investigators Not Provided
PRS Account Queen Mary University of London
Verification Date March 2020