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

COVID-19 Clinical Trial

— COVIDENCE UK  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04330599
• Other study ID #: COVIDENCE UK
• Status: Active, not recruiting
• Start date: May 1, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2023
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13000
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• UK resident

• Age =16 years

Exclusion Criteria: none

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
United Kingdom	Queen Mary University of London	London	County (optional)

Sponsors (7)

Lead Sponsor	Collaborator
Queen Mary University of London	Barts & The London NHS Trust, King's College London, London School of Hygiene and Tropical Medicine, Queen's University, Belfast, Swansea University, University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of confirmed COVID-19		5 years
Secondary	Incidence of probable or suspected COVID-19		5 years
Secondary	Incidence of COVID-19 requiring hospitalisation		5 years
Secondary	Incidence of COVID-19 requiring ventilatory support		5 years
Secondary	Incidence of fatal COVID-19		5 years
Secondary	Symptom duration per COVID-19 episode		5 years
Secondary	Symptom severity per COVID-19 episode		5 years
Secondary	Incidence of seroconversion to SARS-CoV-2		5 years
Secondary	Incidence of recurrent COVID-19		5 years
Secondary	EQ-5D-3L health-related quality of life score		5 years
Secondary	Health care costs associated with incident COVID-19		5 years
Secondary	Impact of the COVID-19 pandemic and the societal response on participants' financial status		5 years
Secondary	Incidence of COVID-19 on participant's physical health		5 years
Secondary	Impact of COVID-19 on participants' mental health		5 years
Secondary	Impact of COVID-19 on physical health of offspring born to participants during follow-up		5 years