Early Pandemic Evaluation and Enhanced Surveillance of the coronavirus COVID-19 (EAVE II)
| ISRCTN | ISRCTN40292537 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40292537 |
| IRAS number | 114474 |
| Secondary identifying numbers | IRAS 114474 |
- Submission date
- 10/08/2020
- Registration date
- 17/11/2020
- Last edited
- 26/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Following the emergence of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in December 2019 and the ensuing COVID-19 pandemic, population-level surveillance and rapid assessment of the effectiveness and safety of existing or new therapeutic or preventive interventions is needed to ensure that interventions are targeted to those at highest risk of serious illness or death from COVID-19. We aim to determine the attack rate of SARS-CoV-2, the uptake, and effectiveness of any new pandemic vaccine (once available) and any protective effect conferred by existing or new antimicrobial drugs and other therapies.
Who can participate?
The setting for this project will be approximately all general practices based throughout Scotland, these practices have about 5,400,000 people registered with them and will be included in the project.
What does the study involve?
Data from the general practices will be linked to data from related healthcare appointments, blood tests, and virus tests to create an anonymised national dataset that will allow estimates of attack rate and vaccine or antiviral effectiveness and safety.
What are the possible benefits and risks of participating?
The will be no risks and no direct benefit to patients, rather this project will help inform policymakers, clinicians and the public on the progress of the epidemic and the relative benefits of any public interventions deployed such as antiviral medicines or vaccines.
Where is the study run from?
The project is being jointly led by Public Health Scotland and the Universities of Edinburgh, Strathclyde, Aberdeen, St Andrews and Glasgow (UK).
When is the study starting and how long is it expected to run for?
From 2020 to September 2021.
Who is funding the study?
The project is funded by the Medical Research Council (MR/R008345/1) and supported by the Scottish Government (UK).
Who is the main contact?
Professor Aziz Sheikh
aziz.sheikh@ed.ac.uk
Contact information
Scientific
The University of Edinburgh
Usher Institute
Medical School
Teviot Place
Edinburgh
EH8 9AG
United Kingdom
 ORCID ID |
0000-0001-7022-3056 |
|---|---|
| Phone | +44 (0)131 651 4151 |
| aziz.sheikh@ed.ac.uk |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet |
| Scientific title | Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II): an observational study using linked Scottish national data |
| Study acronym | EAVE II |
| Study hypothesis | To describe the epidemiology of COVID-19 in Scotland using linked routine sources of primary, secondary, mortality, and virological/serological testing data, and in due course, to help establish the effectiveness and safety of existing or new therapeutic interventions against the coronavirus that are not subjected to formal clinical trials. |
| Ethics approval(s) | Approved 08/07/2020, South East Scotland Research Ethics Committee 02 (Waverley Gate 2-4, Waterloo Place, Edinburgh, EH1 3EG UK; +44 (0)131 536 900; Joyce.Clearie@nhslothian.scot.nhs.uk), ref: 12\SS\0201 |
| Condition | COVID-19 (SARS-CoV-2 infection) |
| Intervention | This is an observational study, no intervention will be given to patients. Any vaccine programmes implemented in Scotland will be assessed for effectiveness. The study will assess these vaccine programmes using linked routine sources of primary, secondary, mortality, and virological/serological testing data from approximately 5.4 million individuals registered with a primary care practice across Scotland. A national linked dataset of patient-level primary care data, out-of-hours, hospitalisation, mortality and laboratory data will be assembled. Self-controlled study designs will be explored to estimate the risk of therapeutic and prophylactic-related adverse events. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Vaccine programmes implemented in Scotland |
| Primary outcome measure | 1. Laboratory confirmed SARS-CoV-2 measured using virological/serological tests between baseline and 9 months 2. Serum from blood samples taken from biochemistry tests (or rapid antibody tests if available) will be used to determine exposure to SARS-CoV-2 infection by the presence of antibodies between baseline and 9 months 3. SARS-CoV-2 infection-related clinical outcomes including general practice, COVID-19 centres and out-of-hours consultations, hospital admissions including secondary bacterial infections and multidrug-resistant bacteria associated with these infections, emergency admissions, out of hours consultations, and deaths between baseline and 9 months |
| Secondary outcome measures | 1. Vaccine uptake proportions measured using primary care practice and hospital data between baseline and 18 months 2. Prevention and reduction of SARS-CoV-2 infection-related general practice consultations, hospital admissions including secondary bacterial infections, emergency admissions, out of hours consultations and deaths due to therapies, vaccines, and antimicrobials between baseline and 18 months 3. Adverse events related to therapies, for example, vaccine, antimicrobial administration, or other therapies measured using participant data between baseline and 18 months |
| Overall study start date | 01/03/2020 |
| Overall study end date | 30/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 5,400,000 |
| Participant inclusion criteria | All (anonymised) patient data will be collected |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/04/2020 |
| Recruitment end date | 31/12/2020 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Old Medical School
Teviot Place
Edinburgh
EH8 9AG
United Kingdom
Sponsor information
Research organisation
c/o Raymond French
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
| Phone | +44 (0)131 242 6226 |
|---|---|
| ray.french@ed.ac.uk | |
| Website | https://www.ed.ac.uk/ |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Protocol can be found at: https://bmjopen.bmj.com/content/10/6/e039097. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to public benefit and privacy approvals that state only aggregate data can be published from this project |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol published at: | 21/06/2020 | Yes | No | |
| Preprint results | non-peer-reviewed results | 19/02/2021 | 23/03/2021 | No | No |
| Results article | 01/05/2022 | 26/05/2022 | Yes | No |
Editorial Notes
26/05/2022: Publication reference added.
23/03/2021: Preprint reference added.
19/03/2021: Internal review.
16/03/2021: Internal review.
12/08/2020: Trial’s existence confirmed by South East Scotland Research Ethics Committee 02.
