(P-338) A Proof of Concept Study to Test the E-CORE Network in Studying Safety and Effectiveness of Treatments in COVID-19 Patients

Background: COVID-19 is a rapidly evolving infectious disease that has reached pandemic status. At the initiative of EMA, a network was created: Evidence for COVID-19 Observational Research Europe (E-CORE). It aims to conduct multicentre studies in COVID-19 patients and to accelerate the generation of robust real-world evidence for COVID-19 . The first study conducted focuses on use of systemic glucocorticoids in the treatment of COVID-19 in the primary and secondary care. A common protocol has been developed for this study.

Objectives: The study objectives include 1) to create and describe the cohorts of COVID-19 patients in seven European countries: demographics, comorbidities, number of cases per month, total of hospital admissions and deaths, and incidence of steroid use 3 months before and after the RECOVERY trial; and 2) to run a feasibility analysis that will inform on a wide range of covariates potentially needed for study execution.

Methods: Data sources covering primary and secondary care settings from seven European countries have been mapped to a common data model. Relevant study variables were described with usual descriptive statistics. COVID-19 diagnosis was determined with a diagnosis code or a positive laboratory test.

Results: Six out of eight databases were analysed (DA Germany, France LDP, Italy LDP, SIDIAP, HM Hospitales and IPCI Netherlands) where last collected data ranged from January 2020 to June 2020 (under update).
The median of COVID-19 patients was 3,600 (range: 1,400 -124,000) up to June 2020. The median age ranged between 42 years (DA Germany) and 69 years (HM Hospitales) and the proportion of male patients ranged between 36% (Italy LPD) and 60% (HM Hospitales). Frequent comorbidities across the six databases included diabetes mellitus (4%-13%), chronic respiratory disease (7%-14%), essential hypertension (11%-30%), and chronic kidney disease (1%-12%). The highest number of COVID-19 cases/database/month ranged from 591 (up to April 2020, IPCI) to 67,452 (up to March 2020, SIDIAP). The number of hospital admissions ranged from zero in all ambulatory databases to n=2,089 in HM Hospitales, the only secondary care database, while SIDIAP reported most deaths (n= 6,478). The incidence of steroid use ranged from 5% (DA Germany) to 12% (IPCI). Currently, only one database contained COVID-19 laboratory data (HM Hospitales). The median follow-up time was 36 days and the median lookback window was 2,302 days.

Conclusions: This project demonstrated that the E-CORE network can create a setup where COVID-19 related research can be performed, helping to understand the effectiveness and safety of medicines for COVID-19 patients.