Lean European Open Survey on SARS-CoV‑2 infected patients (LEOSS)

- Studying SARS-CoV‑2 collectively -


By the begin­ning of 2020, the new SARS-CoV­‑2 was spread­ing rap­idly. Man­dated by the ESCMID Emer­ging Infec­tions Task Force (EITaF) and sup­por­ted by the Ger­man Infec­tious Dis­ease Soci­ety we wanted to bet­ter under­stand the implic­a­tions of the new vir­us on patients by sys­tem­at­ic­ally doc­u­ment­ing patient data.

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LEOSS Sites

Lean European Open Survey on SARS-CoV-2 infected patients (LEOSS)

no informed con­sent neces­sary (anonym­ous reports)
all hos­pit­al­ized patients includ­ing chil­dren eligible
ret­ro­spect­ive doc­u­ment­a­tion after dis­charge /​ death
imme­di­ate start after verification
com­munity-based gov­ernance structure

Why

The SARS-CoV­‑2 pan­dem­ic was a major chal­lenge for med­ic­al pro­fes­sion­als world­wide, with a daily increase of new infections. 

At the begin­ning of the pan­dem­ic, there was a gap of know­ledge regard­ing the best pos­sible clin­ic­al man­age­ment of the infec­tion as well as the pre­dic­tion and pre­ven­tion of severe outcomes.

How

We ini­ti­ated the Lean European Open Sur­vey on SARS-CoV­‑2 (LEOSS) pro­ject, a pro­spect­ive European multi-cen­ter cohort study, to get more in-depth know­ledge about the epi­demi­ology and clin­ic­al course of patients infec­ted with SARS-CoV­‑2.

Our goal was to estab­lish a quick and simple register that allows anonym­ous doc­u­ment­a­tion of patients. The study did allow ret­ro­spect­ive inclu­sion of patients treated before the ini­ti­ation of the study. 

The obtained data can be used to identi­fy inde­pend­ent pre­dict­ors of out­come in patients with dia­gnosed infec­tion by SARS-CoV­‑2. The Data Use and Access Policy developed with­in the LEOSS com­munity allows a dynam­ic and fast sci­entif­ic use of the data while main­tain­ing high sci­entif­ic qual­ity as well as respons­ible pub­lic communication

Variables

The eCRF ensured the doc­u­ment­a­tion of the fol­low­ing items. It was reg­u­larly revised and adjus­ted in cooper­a­tion with med­ic­al soci­et­ies and part­ners accord­ing to their expert­ise and updated information.

Age cat­egory, gender
Coun­try of ori­gin, coun­try of diagnosis
Assumed time of con­tract­ing infection
Import­ant comorbidities
Observed stages of dis­ease (uncom­plic­ated phase, com­plic­ated phase, crit­ic­al phase, recov­ery phase), each with time to event
Baseline val­ues
and more …

We are part of the MDM portal (Med­ic­al data mod­el – medical-data-models.org). It’s a European meta-data register for the cre­ation, ana­lys­is, approv­al, and reuse of med­ic­al forms. In order to enhance trans­par­ency, reusab­il­ity, and com­par­ab­il­ity of dif­fer­ent stud­ies, the LEOSS data mod­el with all data points being encoded via UMLS (Uni­fied Med­ic­al Lan­guage Sys­tem is avail­able online now. You can find it here.

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