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The health burden of COVID-19 and healthcare resource utilization in England

An observational retrospective cohort study describing clinical outcomes and utilization of healthcare resources among persons with COVID-19 in England, stratified by infection severity and selected comorbidities

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN53375662
Enrollment
22000000
Registered
2021-10-21
Start date
2020-09-01
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

Current intervention as of 11/07/2022: This study will use a series of de-identified patient datasets in England, accessible through National Health Services (NHS) Digital. The study period will star

Sponsors

AstraZeneca (United Kingdom)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: This study will include all subjects in England who were active in all datasets described above for at least 1 day during the COVID-19 infection identification period

Exclusion criteria

Exclusion criteria: Current participant exclusion criteria as of 16/12/2022: No general exclusion criteria will be applied for defining the overall study population. Previous participant exclusion criteria: Subjects will be excluded from this study if they have less than 12 months of baseline data prior to 1 September 2020

Design outcomes

Primary

MeasureTime frame
Current primary outcome measures as of 11/07/2022: 1. Size of populations (pre-defined) in England who potentially are ineligible for vaccine or are at risk of COVID-19 infection following vaccination. This will be measure using count (N) of those at risk and the proportion (%) at risk over the baseline period. 2. Incidence of COVID-19, by age group, disease severity, and selected comorbidities during the pre-vaccination and vaccination periods of the study. Incidence will be measured in infections per 100 person-months with 95% confidence intervals. 3. Incidence of long COVID-19 syndrome, by age, disease severity, and selected comorbidities. Incidence will be measured in infections per 100 person-months with 95% confidence intervals. 4. Patterns of HCRU and cost associated with an episode of COVID-19, stratified by age, selected comorbidities, disease severity and the occurrence (vs absence) of long COVID-19 syndrome will be calculated per person per COVID-19 episode. HCRU will be measured by total cost incurred during health care visits. _____ Previous primary outcome measures: 1. Size of populations (pre-defined) in England who potentially are ineligible for vaccine or are at risk of COVID-19 infection following vaccination. This will be measure using count (N) of those at risk and the proportion (%) at risk over the baseline period. 2. Incidence of COVID-19, by age group, disease severity, and selected comorbidities during the pre-vaccination and vaccination periods of the study (1 September 2020-end of study period). Incidence will be measured in infections per 100 person months with 95% confidence intervals. 3. Incidence of long COVID-19 syndrome, by age, disease severity, and selected comorbidities during the pre-vaccination and vaccination periods of the study (1 September 2020-end of study period). Incidence will be measured in infections per 100 person months with 95% confidence intervals. 4. Patterns of HCRU and cost associated with an episode of COVI

Secondary

MeasureTime frame
Current secondary outcome measures as of 16/12/2022: Exploratory Outcome Measures 1. Patients who developed a composite outcome of COVID-19 hospitalisation or COVID-19-related death after vaccination stratified by the number of doses received and explore potential risk factors. This will be measured through estimated relative risks and corresponding 95% confidence intervals. 2. Prediction model, using a clustering algorithm, to identify risk profiles associated with a composite outcome of COVID-19 hospitalisation or COVID-19-related death after the deployment of the vaccination campaign in England and the prevalence of subgroups consistent with each identified risk profile. _____ Previous secondary outcome measures as of 11/07/2022 to 16/12/2022: Exploratory Outcome Measures 1. Patients who developed a composite outcome of COVID-19 hospitalisation or COVID-19-related death after vaccination stratified by the number of doses received and explore potential risk factors. This will be measured through estimated relative risks and corresponding 95% confidence intervals. 2. Prediction model, using cox proportional hazards regression, to identify risk profiles associated with a composite outcome of COVID-19 hospitalisation or COVID-19-related death after the deployment of the vaccination campaign in England and the prevalence of subgroups consistent with each identified risk profile. _____ Previous secondary outcome measures: Exploratory Outcome Measures 1. Patients who developed COVID-19 infection after vaccination are stratified by the number of doses received and explore potential risk factors. This will be measured through estimated relative risks and corresponding 95% confidence intervals. 2. Prediction model, using cox proportional hazards regression, to identify risk profiles associated with COVID-19 infection after the deployment of the vaccination campaign in England and the prevalence of subgroups consistent with each identified risk profile.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026