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LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Neurological sub-cohort

- 27/5/21 - 1 formulario, 24 itemgroups, 156 items, 1 idioma
Itemgroups: Duration of neurological comorbidity, Neurological medication before SARS-CoV-2 infection, Neurological status, Specification of neurological comorbidities, Cerebrovascular disease, Cerebrovascular disease: Medication, Multiple Sclerosis subtype & severity, Multiple Sclerosis: Immunomodulatory medication at Baseline, MS: Immunosuppression discontinuation in context of COVID-19, Recent MS relapse treatment, Neurodegeneration, Cognitive / neuropsychiatric impairment during COVID-19 infection, Visual impairment during COVID-19, Oculomotoric impairment during COVID-19 infection, Paresis during COVID-19 infection, Abnormal muscle reflexes during COVID-19 infection, Sensory deficit during COVID-19 infection, Other neurological findings during COVID-19 infection, Neurological diagnostics; Imaging, Neurological diagnostics: EEG, Neurological diagnostics: Electrophysiology, Neurological diagnostics: Spinal tap, Neurological diagnostics: Spinal tap - pathogens, Is data entry for this section finished?
Study Title: LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients https://leoss.net Study Indication: COVID-19 Date: 19.03.2021 Published with permission by Prof. Dr. med. J.-J. Vehreschild. LEOSS, a multi-center cohort study, has been created to get more in-depth knowledge about the epidemiology and clinical course of patients infected with SARS-CoV-2. Initiated by the ESCMID Emerging Infections Task Force (EITaF) and the German Infectious Disease Society, and supported by all German Centers for Health Research (DZG), LEOSS has developed into an international network of contributors. Via an integrative research approach with anonymous recruitment and collection of routine data in an open science context, LEOSS is building a uniform clinical dataset and providing real-time analyses. For more information feel free to explore https://leoss.net/. This document is for the neurological sub-cohort. If a text field can't be filled out, note 'ND'.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Neurological sub-cohort

- 16/7/21 - 23 formularios, 24 itemgroups, 156 items, 1 idioma
Itemgroups: Duration of neurological comorbidity, Neurological medication before SARS-CoV-2 infection, Neurological status, Specification of neurological comorbidities, Cerebrovascular disease, Cerebrovascular disease: Medication, Multiple Sclerosis subtype & severity, Multiple Sclerosis: Immunomodulatory medication at Baseline, MS: Immunosuppression discontinuation in context of COVID-19, Recent MS relapse treatment, Neurodegeneration, Cognitive / neuropsychiatric impairment during COVID-19 infection, Visual impairment during COVID-19, Oculomotoric impairment during COVID-19 infection, Paresis during COVID-19 infection, Abnormal muscle reflexes during COVID-19 infection, Sensory deficit during COVID-19 infection, Other neurological findings during COVID-19 infection, Neurological diagnostics; Imaging, Neurological diagnostics: EEG, Neurological diagnostics: Electrophysiology, Neurological diagnostics: Spinal tap, Neurological diagnostics: Spinal tap - pathogens, Is data entry for this section finished?
Study Title: LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients https://leoss.net Study Indication: COVID-19 Date: 19.03.2021 Published with permission by Prof. Dr. med. J.-J. Vehreschild. LEOSS, a multi-center cohort study, has been created to get more in-depth knowledge about the epidemiology and clinical course of patients infected with SARS-CoV-2. Initiated by the ESCMID Emerging Infections Task Force (EITaF) and the German Infectious Disease Society, and supported by all German Centers for Health Research (DZG), LEOSS has developed into an international network of contributors. Via an integrative research approach with anonymous recruitment and collection of routine data in an open science context, LEOSS is building a uniform clinical dataset and providing real-time analyses. For more information feel free to explore https://leoss.net/. Please note that only cases with known outcome are collected! Baseline / diagnosis is defined as the day the sample of the first positive SARS-CoV-2 result was taken. Criteria of the Uncomplicated Phase: Asymptomatic OR Symptoms of upper respiratory tract infection and/or Nausea, emesis, diarrhea and/or Fever Remember: The Uncomplicated Phase ends, if a previously febrile patient has no fever anymore and has completed 14 days of follow-up without entering Complicated or Critical Phase; then move to Recovery Phase. Also, as soon as one of the criteria of the Complicated or Critical Phase are fulfilled, Uncomplicated Phase ends; move over to there. If the patient has died, the phase ends with the death of the patient. If the patient has died, do not report terminal values, e.g. those recorded after switching off life-support or heart rate "0" after death of the patient. Criteria of the Complicated Phase: * Need for oxygen supplementation (In patients with prior oxygen home therapy, clinically meaningful increase in need for oxygenation.) * paO2 at room air < 70 mmHg * SO2 at room air < 90 % * GOT or GPT > 5x ULN * New cardiac arrhythmia * New pericardial effusion >1cm * New heart failure with pulmonary edema, congestive hepatopathy or peripheral edema Remember: The Complicated Phase ends, if none of the criteria for the Complicated Phase is fulfilled anymore AND the patient is free of fever; then move to Recovery Phase. Also, as soon as one of the criteria of the Critical Phase are fulfilled, Complicated Phase ends; move over to Critical Phase. If the patient has died, the phase ends with the death of the patient. If the patient has died, do not report terminal values, e.g. those recorded after switching off life-support or heart rate "0" after death of the patient. Criteria of the Critical Phase: * Need for catecholamines * Life-threatening cardiac arrhythmia * Mechanical ventilation (invasive or non-invasive) * Liver failure with Quick< 50% * qSOFA >= 2 * Renal failure in need of dialysis Remember: The Critical Phase ends as soon as none of the criteria for the Critical Phase is fulfilled anymore AND the patient is free of fever. If the patient has died, it ends with the death of the patient. If the patient has died, do not report terminal values, i.e. those recorded after turning off life-support or heart rate "0" after death of the patient. Criteria of the Recovery Phase: *Improvement by at least one phase, i.e. Critical to Complicated or Complicated to Uncomplicated * Defervescence Remember: Uncomplicated asymptomatic patients enter recovery phase after 14 days of observation without disease progression No further progression or re-hospitalization If a text field can't be filled out, note 'ND' (for not determined).

Recovery Phase

15 itemgroups 80 items

Complicated Phase

28 itemgroups 155 items

Critical Phase

32 itemgroups 188 items

Immunosuppressive premedication

31 itemgroups 90 items

Baseline I

39 itemgroups 280 items

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Recovery Phase

- 28/6/21 - 1 formulario, 15 itemgroups, 80 items, 1 idioma
Itemgroups: RC: Respiratory findings, RC: Cardiovascular findings, RC: Neurological findings, RC: Further findings, RC: Vitals, RC: Lung ultrasound, RC: worst chest CT result, RC: Co/Superinfections, RC: Antibacterial treatment: Betalactams, RC: Antibacterial treatment: Macrolides, RC: Antibacterial treatment: Other antibacterial treatment, RC: Multiple sclerosis, severity after COVID-19 infection, RC: Pulmonary function test (Spirometry), RC: Deterioration of prior chronic pulmonary disease, RC: Is data entry for this section finished?
Study Title: LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients https://leoss.net Study Indication: COVID-19 Date: 19.03.2021 Published with permission by Prof. Dr. med. J.-J. Vehreschild. LEOSS, a multi-center cohort study, has been created to get more in-depth knowledge about the epidemiology and clinical course of patients infected with SARS-CoV-2. Initiated by the ESCMID Emerging Infections Task Force (EITaF) and the German Infectious Disease Society, and supported by all German Centers for Health Research (DZG), LEOSS has developed into an international network of contributors. Via an integrative research approach with anonymous recruitment and collection of routine data in an open science context, LEOSS is building a uniform clinical dataset and providing real-time analyses. For more information feel free to explore https://leoss.net/. This document is for data aggregated in the recovery phase. If a text field can't be filled out, note 'ND'. Criteria of the Recovery Phase: Improvement by at least one phase, i.e. Critical to Complicated or Complicated to Uncomplicated Defervescence Remember: Uncomplicated asymptomatic patients enter recovery phase after 14 days of observation without disease progression No further progression or re-hospitalization

GECCO - German Corona Consensus - Covid-19 Research-Dataset - Symptome

- 5/1/23 - 13 formularios, 7 itemgroups, 80 items, 1 idioma
Itemgroups: Symptome, Atemwegssymptome, Systemische Symptome, Neurologische/Psychiatrische Symptome, Schmerzen, Magendarmsymptome, Andere Symptome
Disclaimer: Der „GECCO - German Corona Consensus - Covid-19 Research-Dataset“ Inhalt, der auf dem Portal für medizinische Datenmodelle (MDM Portal) zu finden ist, ersetzt nicht den GECCO Datensatz auf simplifier.net. Für die Nutzung von GECCO-FHIR-Profilen verwenden Sie bitte die auf https://simplifier.net/ForschungsnetzCovid-19/ verfügbaren Profile. Der FHIR-Download auf MDM erzeugt lediglich eine FHIR-Fragebogenresource. Ziel Überarbeitung August 2021: höhere Kompatibilität mit der NUM-COMPASS-App bzw. der Schnittstelle zur zentralen Datenbank; Zwischenstand, gewisse Module sind noch nicht kompatibel mit der Schnittstelle (u.a. Medikation und Laborwerte; Beatmungstherapie ist aktuell doppelt hinterlegt) This version of the GECCO logical model is based on https://art-decor.org/art-decor/decor-datasets--covid19f-, and the implementation for REDCap by the University of Tübingen (3.3.2021), partially updated with https://simplifier.net/guide/GermanCoronaConsensusDataSet-ImplementationGuide/Home information. For actual use of FHIR profiles, please use the actual profiles available on https://simplifier.net/ForschungsnetzCovid-19/ResearchDatasetGECCO/~overview (FHIR download on MDM is only a FHIR questionnaire resource). This version is not compatible with the REDCap to FHIR GECCO converter of the University of Tübingen. It aims at a higher compatibility with the app generated for the NUM-COMPASS project (conversion to COMPASS-compatible FHIR questionnaire necessary) and from there with the central platform of the NUM-CODEX project. A few modules are not yet compatible (e.g. Medication and lab values; ventilation is currently double). Official German text from http://cocos.team/datasets.html: Zur Bewältigung der aktuellen Pandemie und der damit einhergehenden Behandlung von Patienten fördert das Bundesministerium für Bildung und Forschung (BMBF) ein nationales Netzwerk der Universitätsmedizin im Kampf gegen COVID-19. Unter anderem soll das Netzwerk die Daten der behandelten COVID-19 Patienten systematisch erfassen und bündeln. Die Forschenden sollen die Behandlung der COVID-19-Patienten standardisiert erheben, verfolgen und analysieren. Die hohe Bedrohungslage hat zu intensiver wissenschaftlicher Aktivität zu COVID-19 geführt, wozu zahlreiche regionale, nationale und internationale epidemiologische Erhebungen und Registerstudien zählen. Der Konsensusdatensatz gibt der Wissenschaft um COVID-19 eine gemeinsame Sprache und Arbeitsgrundlage. Inofficial translation: In order to cope with the current pandemic and the associated treatment of patients, the Federal Ministry of Education and Research (BMBF) is funding a national network of university medicine in the fight against COVID-19. Among other things, the network will systematically collect and bundle the data of the treated COVID-19 patients. The researchers are to collect, track and analyze the treatment of COVID-19 patients in a standardized way. The high threat level has led to intensive scientific activity on COVID-19, including numerous regional, national and international epidemiological surveys and register studies. The consensus data set provides a common language and working basis for the science around COVID-19.

Anamnese/Risikofaktoren

16 itemgroups 101 items

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Complicated Phase

- 22/6/21 - 1 formulario, 28 itemgroups, 155 items, 1 idioma
Itemgroups: CO: Symptoms / Findings, CO: Feeling of breathlessness, CO: Fever, CO: Vitals, CO: Lung ultrasound, CO: worst chest CT result, CO: Antivirals, CO: Antibiotics, CO: Antifungals, CO: Immunomodulators, CO: Cardiovascular medication, CO: Non-oral anticoagulants, CO: Oral anticoagulants, CO: Platelet aggregation inhibition, CO: Further anticoagulation / platelet aggregation inhibition, CO: Other COVID-19 related therapy, CO: Co/Superinfections, CO: Antibacterial treatment, Betalactams, CO: Antibacterial treatment: Macrolides, CO: Antibacterial treatment: Other antibacterial treatment, CO: Complications, Thrombotic and thromboembolic manifestations, CO: Complications, Neurological, CO, Ischemic stroke: TOAST classification, CO, Ischemic stroke: NIHSS score in acute phase, CO: Complications, Other, CO, Acute kidney injury (KDIGO criteria), CO: SOFA score, CO: Is data entry for this section finished?
Study Title: LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients https://leoss.net Study Indication: COVID-19 Date: 19.03.2021 Published with permission by Prof. Dr. med. J.-J. Vehreschild. LEOSS, a multi-center cohort study, has been created to get more in-depth knowledge about the epidemiology and clinical course of patients infected with SARS-CoV-2. Initiated by the ESCMID Emerging Infections Task Force (EITaF) and the German Infectious Disease Society, and supported by all German Centers for Health Research (DZG), LEOSS has developed into an international network of contributors. Via an integrative research approach with anonymous recruitment and collection of routine data in an open science context, LEOSS is building a uniform clinical dataset and providing real-time analyses. For more information feel free to explore https://leoss.net/. This document is for data aggregated in the complicated phase. If a text field can't be filled out, note 'ND'. Criteria of the Complicated Phase: Need for oxygen supplementation (In patients with prior oxygen home therapy, clinically meaningful increase in need for oxygenation.) paO2 at room air < 70 mmHg SO2 at room air < 90 % GOT or GPT > 5x ULN New cardiac arrhythmia New pericardial effusion >1cm New heart failure with pulmonary edema, congestive hepatopathy or peripheral edema Remember: The Complicated Phase ends, if none of the criteria for the Complicated Phase is fulfilled anymore AND the patient is free of fever; then move to Recovery Phase. Also, as soon as one of the criteria of the Critical Phase are fulfilled, Complicated Phase ends; move over to Critical Phase. If the patient has died, the phase ends with the death of the patient. If the patient has died, do not report terminal values, e.g. those recorded after switching off life-support or heart rate "0" after death of the patient.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Critical Phase

- 23/6/21 - 1 formulario, 32 itemgroups, 188 items, 1 idioma
Itemgroups: CR: Cardiovascular findings, CR: Respiratory findings, CR: Other severe organ damage, CR: Fever, CR: Vitals, CR: Lung ultrasound, CR: worst chest CT result, CR: Antivirals, CR: Antibiotics, CR: Antifungals, CR: Immunomodulators, CR: Cardiovascular medication, CR: Non-oral anticoagulants, CR: Oral anticoagulants, CR: Platelet aggregation inhibition, CR: Further anticoagulation / platelet aggregation inhibition, CR: Other COVID-19 related therapy, CR: ICU treatment, CR: Mechanical ventilation, CR: Other extracorporeal support, CR: Co/Superinfections, CR: Antibacterial treatment: Betalactams, CR: Antibacterial treatment: Macrolides, CR: Other antibacterial treatment, CR: Complications, Thrombotic and thromboembolic manifestations, CR: Complications, Neurological, Ischemic stroke: TOAST classification, Ischemic stroke: NIHSS score in acute phase, CR: Complications, Other, Acute kidney injury (KDIGO criteria), CR: SOFA score, CR: Is data entry for this section finished?
Study Title: LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients https://leoss.net Study Indication: COVID-19 Date: 19.03.2021 Published with permission by Prof. Dr. med. J.-J. Vehreschild. LEOSS, a multi-center cohort study, has been created to get more in-depth knowledge about the epidemiology and clinical course of patients infected with SARS-CoV-2. Initiated by the ESCMID Emerging Infections Task Force (EITaF) and the German Infectious Disease Society, and supported by all German Centers for Health Research (DZG), LEOSS has developed into an international network of contributors. Via an integrative research approach with anonymous recruitment and collection of routine data in an open science context, LEOSS is building a uniform clinical dataset and providing real-time analyses. For more information feel free to explore https://leoss.net/. This document is for data aggregated in the critical phase. If a text field can't be filled out, note 'ND'. Criteria of the Critical Phase: Need for catecholamines Life-threatening cardiac arrhythmia Mechanical ventilation (invasive or non-invasive) Liver failure with Quick< 50% qSOFA >= 2 Renal failure in need of dialysis Remember: The Critical Phase ends as soon as none of the criteria for the Critical Phase is fulfilled anymore AND the patient is free of fever. If the patient has died, it ends with the death of the patient. If the patient has died, do not report terminal, i.e. those recorded after turning off life-support or heart rate "0" after death of the patient.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Immunosuppressive premedication

- 7/5/21 - 1 formulario, 31 itemgroups, 90 items, 1 idioma
Itemgroups: Antibodies: Anti-CD20, Antibodies: CD-22, Antibodies: CD-38, Antibodies: CD-52, Antibodies: Anti-CD79b, Antibodies: BLyS, Antibodies: CD19-BiTE, Antibodies: Complement inhibitors, Antibodies: Integrin antagonists, Antibodies: Interleukin inhibitors, Antibodies: TNF-alpha inhibitors, Other Antibodies, Inhibitors: Co-stimulation inhibitors, Inhibitors: Calcineurin inhibitors, Inhibitors: Interleukin inhibitor, Inhibitors: JAK inhibitors, Inhibitors: mTOR inhibitors, Inhibitor: PDE-4-inhibitor, Other Inhibitors, Recent: Checkpoint inhibitors, Chemotherapeutics: Antimetabolites, Chemotherapeutics: Cytostatics, Other Chemotherapeutics, Corticosteroids, Other immunosuppressive regimens: Fumarate, Other immunosuppressive regimens: Immunoglobulines, Other immunosuppressive regimens: Interferon, Immunosuppressive regimens: Other Multiple Sclerosis drugs, Other immunosuppressive regimens, Immunosuppressive drugs: Underlying disease, Is data entry for this section finished?
Study Title: LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients https://leoss.net Study Indication: COVID-19 Date: 19.03.2021 Published with permission by Prof. Dr. med. J.-J. Vehreschild. LEOSS, a multi-center cohort study, has been created to get more in-depth knowledge about the epidemiology and clinical course of patients infected with SARS-CoV-2. Initiated by the ESCMID Emerging Infections Task Force (EITaF) and the German Infectious Disease Society, and supported by all German Centers for Health Research (DZG), LEOSS has developed into an international network of contributors. Via an integrative research approach with anonymous recruitment and collection of routine data in an open science context, LEOSS is building a uniform clinical dataset and providing real-time analyses. For more information feel free to explore https://leoss.net/. This document is for immunosuppressive premedication. If a text field can't be filled out, note 'ND'.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Baseline I

- 24/6/21 - 1 formulario, 39 itemgroups, 280 items, 1 idioma
Itemgroups: Sociodemography, Comorbidities, Central nervous system / Neurological disesases, Comorbidities, Cardiovascular diseases, Comorbidities, Pulmonary diseases, Comorbidities, Hematological / oncological diseases, Comorbidities, Rheumatological diseases, Comorbidities, Allergology, Comorbidities, Other internal disorders, Comorbidities, Other conditions, Body-Mass-Index (BMI), Smoking status, Use of e-cigarettes and / or vaporizer?, Pre-existing treatment, Recent immunosuppressive medication, Colonisation with multi-resistant pathogens, Disease limiting life expectancy before positive SARS-CoV-2 testing, Follow-up duration after SARS-CoV-2 diagnosis, Last known status, Diagnosis context, COVID-19 diagnosis details, Complications at baseline: Thrombotic and thromboembolic manifestations, Complications at baseline: Neurological, Complications at baseline: Other severe organ damage, Complications at baseline: Other, Disease course, Duration (days) of..., Symptoms: Please click all symptoms which occurred in the respective clinical phase, Vitals, Lung ultrasound results at SARS-CoV-2 detection, Baseline: Chest CT results at SARS-CoV-2 detection, Heart function, Echocardiography: Ejection fraction (EF) at SARS-CoV-2 detection, Cardiovascular magnetic resonance imaging (CMR) performed in any clinical phase, Neurological diagnostic in various phases, Complementary and/or integrative medicine (CIM) used in any phase, Discussion of limitation of therapy during SARS-CoV-2 infection, Specialist palliative care during SARS-CoV-2 infection, Agreement to share data for scientific purposes, Biomaterial availability for research proposes, Participation in interventional clinical trials
Study Title: LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients https://leoss.net Study Indication: COVID-19 Date: 19.03.2021 Published with permission by Prof. Dr. med. J.-J. Vehreschild. LEOSS, a multi-center cohort study, has been created to get more in-depth knowledge about the epidemiology and clinical course of patients infected with SARS-CoV-2. Initiated by the ESCMID Emerging Infections Task Force (EITaF) and the German Infectious Disease Society, and supported by all German Centers for Health Research (DZG), LEOSS has developed into an international network of contributors. Via an integrative research approach with anonymous recruitment and collection of routine data in an open science context, LEOSS is building a uniform clinical dataset and providing real-time analyses. For more information feel free to explore https://leoss.net/. This document is for baseline information. A related document "Baseline II" documents further baseline information related to baseline timepoint and to disease periods. Baseline / diagnosis is defined as the day the sample of the first positive SARS-CoV-2 result was taken. Please note that only cases with known outcome are collected! If a text field can't be filled out, note 'ND' (for not determined).

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