Who initiated the LEOSS project?

The EITaF and the Ger­man Soci­ety for Infec­tious Dis­eases have joined forces to estab­lish a clin­ic­al patient registry for patients infec­ted with SARS-CoV­‑2.

What are the goals and visions of this project?

The goal of LEOSS is to estab­lish a quick and simple register that allows anonym­ous doc­u­ment­a­tion of patients, in order to get more in-depth know­ledge about the epi­demi­ology and clin­ic­al course of patients infec­ted with SARS-CoV­‑2.

What happens with the data and who governs it?

All sur­vey res­ults will be reg­u­larly pub­lished to the sci­entif­ic com­munity for crowd-based ana­lys­is. The sur­vey will be self-gov­erned by a Board of Invest­ig­at­ors con­sist­ing of the con­trib­ut­ing cen­ters, with Coun­try Coordin­at­ors and ESCMID rep­res­ent­at­ives giv­ing addi­tion­al input.

I have heard of other surveys on SARS-CoV‑2. Why should I contribute to LEOSS?

At the begin­ning of March, the Ger­man Soci­ety for Infec­ti­ology (DGI) approached us to estab­lish a European case registry for patients with SARS-CoV­‑2 infec­tion with a broad-based team of experts, sup­por­ted by the Emer­ging Infec­tions Task Force of ESCMID. We decided to do this because there have been repeated calls for free, anonym­ous data entry, e.g. also for patients who are unable to give their con­sent. The res­ult was the Lean European Open Sur­vey for SARS-CoV­‑2 Infec­ted Patients (LEOSS). We chose an open, anonym­ous doc­u­ment­a­tion approach, without patient con­sent, in order to be as time effi­cient and com­pre­hens­ive as pos­sible.

We invite you to con­tact us if you would like to estab­lish a col­lab­or­a­tion between LEOSS and oth­er SARS-CoV­‑2 related cohort stud­ies.

Who can participate in the LEOSS project?

LEOSS is a European case registry for SARS-CoV­‑2. How­ever, LEOSS is an open access for the research com­munity and non-European coun­tries are also wel­come to par­ti­cip­ate.

Which patients can be included in LEOSS?

Patients with con­firmed SARS-CoV 2 infec­tion by PCR can be included. In out­pa­tient set­tings addi­tion­ally to med­ic­al his­tory and known out­come labor­at­ory val­ues and vital signs should be determ­ined at least once.

How long does it take to enter a patient case?

It takes about 10–25 minutes to enter a full patient case.

At what point do I document the case of a positive tested SARS-CoV‑2 patient?

Data col­lec­tion is best to be per­formed ret­ro­spect­ively after a patient case has been com­pleted (treat­ment is fin­ished or patient’s death). But due to the neces­sity to fight this ongo­ing pan­dem­ic, also the doc­u­ment­a­tion of on-going patient cases is viable.

Where can I document my patients and how can I get an access to the eCRF?

The eCRF will be access­ible through www.clinicalsurveys.net. Part­ner sites wish­ing to con­trib­ute need to request account-details for login via email. Please con­tact registration@leoss.net. Please be aware that all invest­ig­at­ors can only view and modi­fy their own con­tri­bu­tions. You can cre­ate a joint account for your ward or clin­ic by using one email address.

How is the data collected and stored?

The data will be col­lec­ted via an elec­tron­ic case report form (eCRF) provided by using the ClinicalSurveys.net online plat­form of the Uni­ver­sity Hos­pit­al of Cologne (UHC). ClinicalSurveys.net is hos­ted by Quest­Back, Oslo, Nor­way on serv­ers in Cologne, Ger­many as part of a soft­ware-as-a-ser­vice agree­ment. All data trans­mis­sions are encryp­ted via TLS 1.2 with an AES 256 GCM bit key and ECDHE RSA key exchange; cer­ti­fic­ate provided by COMODO RSA Domain Val­id­a­tion Serv­er. Data is doc­u­mented anonym­ously; no dir­ectly identi­fy­ing data are stored on Quest­Back serv­ers. Reg­u­lar data-backup, hier­arch­ic man­age­ment of rights and authen­tic­a­tion pro­to­cols ensure the pro­tec­tion of data from unau­thor­ized access and loss.

How should I proceed with already completed cases in the context of on-going modifications of the eCRF?

The eCRF is mod­i­fied in cooper­a­tion with med­ic­al soci­et­ies and part­ners accord­ing to their expert­ise and updated inform­a­tion. We do not expect any sub­sequent doc­u­ment­a­tion of an already com­pleted case. The patient’s doc­u­ment­a­tion is com­plete con­sid­er­ing the sur­vey at the respect­ive point of doc­u­ment­a­tion.

Who is responsible for data security?

Con­tracts between the Uni­ver­sity Hos­pit­al Cologne and Quest­Back reg­u­late own­er­ship and respons­ib­il­ity for data, secur­ity and eCRFs. Reg­u­lar on-site audits of secur­ity and data pro­tec­tion meas­ures are per­formed at Quest­Back Cologne by the Uni­ver­sity Hos­pit­al of Cologne.

Who can get access the dataset and for what purposes can the data be used?

For all col­lab­or­at­ors an anonymised data set will be avail­able, pro­tec­ted by a pass­word. There will be no lim­it for col­lab­or­at­ors to request­ing access to the anonymised data set and the ana­lyses made with the data set. This allows ana­lys­is of the data set for research pur­poses and pub­lic health interests in the con­text of the SARS-CoV­‑2 pan­dem­ic. All use for oth­er research ques­tions or for fin­an­cial gain of indi­vidu­als or cor­por­a­tions will be pro­hib­ited.

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