Early Pandemic Evaluation and Enhanced Surveillance of the coronavirus COVID-19 (EAVE II)

ISRCTN	ISRCTN40292537
DOI	https://doi.org/10.1186/ISRCTN40292537
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	114474
Protocol serial number	IRAS 114474
Sponsor	Academic and Clinical Centre Office for Research and Development (ACCORD) (UK)
Funder	Medical Research Council

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Prof Aziz Sheikh
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
Email	aziz.sheikh@ed.ac.uk

Study information

Primary study design	Observational
Study design	Prospective observational cohort study
Secondary study design	Cohort study
Study type	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 objectives	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
Health condition(s) or problem(s) studied	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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Vaccine programmes implemented in Scotland
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/09/2021

Eligibility

Participant type(s)	Patient
Age group	All
Sex	All
Target sample size at registration	5400000
Key inclusion criteria	All (anonymised) patient data will be collected
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/04/2020
Date of final enrolment	31/12/2020

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

The University of Edinburgh

Usher Institute
Old Medical School
Teviot Place
Edinburgh
EH8 9AG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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?
Results article		01/05/2022	26/05/2022	Yes	No
Protocol article	protocol published at:	21/06/2020		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Preprint results	non-peer-reviewed results	19/02/2021	23/03/2021	No	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.