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

• Sponsor: Queen Mary University of London (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04330599
• Collaborator: King's College London (Other), London School of Hygiene and Tropical Medicine (Other), University of Edinburgh (Other), Swansea University (Other), Queen's University, Belfast (Other), Barts & The London NHS Trust (Other)
• Enrollment: 13,000
• Location: 1
• Anticipated Duration (Months): 59
• Patients Per Site Per Month: 220.3

Study Details

Study Description

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	Intervention/Treatment	Phase
COVID-19

Study Design

• 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
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 1, 2025

Outcome Measures

Primary Outcome Measures

1. Incidence of confirmed COVID-19 [5 years]

Secondary Outcome Measures

1. Incidence of probable or suspected COVID-19 [5 years]

2. Incidence of COVID-19 requiring hospitalisation [5 years]

3. Incidence of COVID-19 requiring ventilatory support [5 years]

4. Incidence of fatal COVID-19 [5 years]

5. Symptom duration per COVID-19 episode [5 years]

6. Symptom severity per COVID-19 episode [5 years]

7. Incidence of seroconversion to SARS-CoV-2 [5 years]

8. Incidence of recurrent COVID-19 [5 years]

9. EQ-5D-3L health-related quality of life score [5 years]

10. Health care costs associated with incident COVID-19 [5 years]

11. Impact of the COVID-19 pandemic and the societal response on participants' financial status [5 years]

12. Incidence of COVID-19 on participant's physical health [5 years]

13. Impact of COVID-19 on participants' mental health [5 years]

14. Impact of COVID-19 on physical health of offspring born to participants during follow-up [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• UK resident

• Age ≥16 years

Exclusion Criteria: none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Queen Mary University of London
• ClinicalTrials.gov Identifier: NCT04330599
• Other Study ID Numbers: COVIDENCE UK
• First Posted: Apr 1, 2020
• Last Update Posted: Jan 31, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Jan 31, 2022