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

• ClinicalTrials.gov Identifier: NCT04330599
• Recruitment Status: Active, not recruiting
• First Posted: April 1, 2020
• Last Update Posted: January 31, 2022
• 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
• 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: January 31, 2022
• 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 ]

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

Retention:   Samples Without DNA

Description:

Eluates from dried blood spots

• 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 *

• Williamson AE, Tydeman F, Miners A, Pyper K, Martineau AR. Short-term and long-term impacts of COVID-19 on economic vulnerability: a population-based longitudinal study (COVIDENCE UK). BMJ Open. 2022 Aug 23;12(8):e065083. doi: 10.1136/bmjopen-2022-065083.
• 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. 2022 Sep;77(9):900-912. doi: 10.1136/thoraxjnl-2021-217487. Epub 2021 Nov 30.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 14, 2022): 13000
• Original Estimated Enrollment (submitted: March 31, 2020): 12000
• 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 information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

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

• Current Responsible Party: Queen Mary University of London
• Original Responsible Party: Same as current
• Current Study Sponsor: Queen Mary University of London
• Original Study Sponsor: Same as current

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: January 2022