Clinical trial NCT04330599: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: King's College London
name: London School of Hygiene and Tropical Medicine
name: University of Edinburgh
name: Swansea University
name: Queen's University, Belfast
name: Barts & The London NHS Trust
First posted: 2020-04-01
Enrollment: 13000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UK residents aged 16 years or more

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.


Eligibility criteria: Inclusion Criteria:

* UK resident
* Age ≥16 years

Exclusion Criteria: none

Primary outcomes:
measure: Incidence of confirmed COVID-19
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of probable or suspected COVID-19
timeFrame: 5 years
measure: Incidence of COVID-19 requiring hospitalisation
timeFrame: 5 years
measure: Incidence of COVID-19 requiring ventilatory support
timeFrame: 5 years
measure: Incidence of fatal COVID-19
timeFrame: 5 years
measure: Symptom duration per COVID-19 episode
timeFrame: 5 years
measure: Symptom severity per COVID-19 episode
timeFrame: 5 years
measure: Incidence of seroconversion to SARS-CoV-2
timeFrame: 5 years
measure: Incidence of recurrent COVID-19
timeFrame: 5 years
measure: EQ-5D-3L health-related quality of life score
timeFrame: 5 years
measure: Health care costs associated with incident COVID-19
timeFrame: 5 years
measure: Impact of the COVID-19 pandemic and the societal response on participants' financial status
timeFrame: 5 years
measure: Incidence of COVID-19 on participant's physical health
timeFrame: 5 years
measure: Impact of COVID-19 on participants' mental health
timeFrame: 5 years
measure: Impact of COVID-19 on physical health of offspring born to participants during follow-up
timeFrame: 5 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Mary University of London
state: County (optional)
Study officials:
References:
citation: 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.
citation: 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.