Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II): protocol for an observational study using linked Scottish national data

Colin R Simpson, Chris Robertson, Eleftheria Vasileiou* (Corresponding Author), Jim McMenamin, Rory Gunson, Lewis D Ritchie, Mark Woolhouse, Lynn Morrice, Dave Kelly, Helen R Stagg, Diogo Marques, Josie Murray, Aziz Sheikh

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

54 Citations (Scopus)
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INTRODUCTION: 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 of existing or new therapeutic or preventive interventions are required to ensure that interventions are targeted to those at highest risk of serious illness or death from COVID-19. We aim to repurpose and expand an existing pandemic reporting platform 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.

METHODS AND ANALYSIS: A prospective observational cohort will be used to monitor daily/weekly the progress of the COVID-19 epidemic and to evaluate the effectiveness of therapeutic interventions in approximately 5.4 million individuals registered in general practices across Scotland. A national linked dataset of patient-level primary care data, out-of-hours, hospitalisation, mortality and laboratory data will be assembled. The primary outcomes will measure association between: (A) laboratory confirmed SARS-CoV-2 infection, morbidity and mortality, and demographic, socioeconomic and clinical population characteristics; and (B) healthcare burden of COVID-19 and demographic, socioeconomic and clinical population characteristics. The secondary outcomes will estimate: (A) the uptake (for vaccines only); (B) effectiveness; and (C) safety of new or existing therapies, vaccines and antimicrobials against SARS-CoV-2 infection. The association between population characteristics and primary outcomes will be assessed via multivariate logistic regression models. The effectiveness of therapies, vaccines and antimicrobials will be assessed from time-dependent Cox models or Poisson regression models. Self-controlled study designs will be explored to estimate the risk of therapeutic and prophylactic-related adverse events.

ETHICS AND DISSEMINATION: We obtained approval from the National Research Ethics Service Committee, Southeast Scotland 02. The study findings will be presented at international conferences and published in peer-reviewed journals.

Original languageEnglish
Article numbere039097
Number of pages7
JournalBMJ Open
Issue number6
Early online date21 Jun 2020
Publication statusPublished - 2020

Bibliographical note

The authors would like to thank and acknowledge Kenny Fraser at Triscribe Ltd and Keith Moffat at Public Health Scotland for their support in this study.


  • COVID-19
  • Pandemics
  • epidemiology
  • respiratory medicine (see thoracic medicine)
  • public health


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