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LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Diagnostics (General virological and laboratory findings for all phases)

- 16/07/21 - 23 moduli, 46 itemgroups, 320 elementi, 1 linguaggio
Itemgroups: Baseline: SARS-CoV-2, Virological testing types, Baseline: PCR: Site of first detected SARS-CoV-2, Baseline: PCR: Tested target at first positive SARS-CoV-2 testing, BL: PCR pharyngeal swabs at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, Baseline: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, Baseline: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, Baseline: Laboratory values, Baseline: Blood Count, Baseline: Other laboratory results, Baseline: Urine test, UC: SARS-CoV-2, Virological testing types, UC: PCR Sites, UC: PCR pharyngeal swab at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, UC: Viral coinfections, UC: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, UC: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, UC: Laboratory values, UC: Blood count, UC: Other laboratory results, CO: SARS-CoV-2, Virological testing, CO: PCR Sites, CO: PCR pharyngeal swab at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, CO: Viral coinfections, CO: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, CO: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, CO: Laboratory values, CO: Blood count, CO: Other laboratory results, CR: SARS-CoV-2, Virological testing types, CR: PCR Sites, CR: PCR pharyngeal swabs at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, CR: Viral coinfections, CR: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, CR: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, CR: Laboratory values, CR: Blood count, CR: Other laboratory results, RC: SARS-CoV-2, Virological testing types, RC: PCR Sites, RC: PCR pharyngeal swabs at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, RC: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, RC: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, RC: Laboratory values, RC: Blood count, RC: Other laboratory results, Diagnostics: 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).

Liver cirrhosis sub-cohort

10 itemgroups 48 elementi

Baseline I

39 itemgroups 280 elementi

Immunosuppressive premedication

31 itemgroups 90 elementi

HIV sub-cohort

13 itemgroups 55 elementi

Diabetes mellitus sub-cohort

11 itemgroups 26 elementi

Cardiovascular sub-cohort

3 itemgroups 9 elementi

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Diagnostics (General virological and laboratory findings for all phases)

- 08/06/21 - 1 modulo, 46 itemgroups, 320 elementi, 1 linguaggio
Itemgroups: Baseline: SARS-CoV-2, Virological testing types, Baseline: PCR: Site of first detected SARS-CoV-2, Baseline: PCR: Tested target at first positive SARS-CoV-2 testing, BL: PCR pharyngeal swabs at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, Baseline: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, Baseline: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, Baseline: Laboratory values, Baseline: Blood Count, Baseline: Other laboratory results, Baseline: Urine test, UC: SARS-CoV-2, Virological testing types, UC: PCR Sites, UC: PCR pharyngeal swab at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, UC: Viral coinfections, UC: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, UC: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, UC: Laboratory values, UC: Blood count, UC: Other laboratory results, CO: SARS-CoV-2, Virological testing, CO: PCR Sites, CO: PCR pharyngeal swab at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, CO: Viral coinfections, CO: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, CO: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, CO: Laboratory values, CO: Blood count, CO: Other laboratory results, CR: SARS-CoV-2, Virological testing types, CR: PCR Sites, CR: PCR pharyngeal swabs at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, CR: Viral coinfections, CR: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, CR: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, CR: Laboratory values, CR: Blood count, CR: Other laboratory results, RC: SARS-CoV-2, Virological testing types, RC: PCR Sites, RC: PCR pharyngeal swabs at first positive SARS-CoV-2 testing: lowest detected number of PCR cycles, RC: Anti-SARS-CoV-2 antibodies (IgG) highest titer measurement, RC: Anti-SARS-CoV-2 antibodies (IgA) highest titer measurement, RC: Laboratory values, RC: Blood count, RC: Other laboratory results, Diagnostics: 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 general virological and laboratory findings at baseline and aggregated for all phases. If a text field can't be filled out, note 'ND'. Please keep in mind that the clinical phases represent time intervals while the baseline is a point in time. Data input of baseline and the clinical phase at diagnosis can but do not have to be identical.

ISARIC/WHO Novel Coronavirus (nCoV) / COVID-19 Case Record Form - MODULE 3: OUTCOME CASE REPORT FORM

- 20/09/21 - 1 modulo, 12 itemgroups, 138 elementi, 1 linguaggio
Itemgroups: Participant Identification, Treatment, Complications, Diagnostics, Biospecimen Testing, Antiviral therapy, Antibiotic therapy, Corticosteroids, Heparin, Antifungal therapy, Other treatments administered for COVID-19, Outcome
This CRF is set up in modules to be used for recording data on the ISARIC COVID-19 Core Database or for independent studies. Module 1 and Module 2 complete on the first day of presentation/admission or on first day of COVID-19 assessment. Module 2 also complete on first day of admission to ICU or high dependency unit. In addition, complete daily for as many days as resources allow up to a maximum of 14 days. Continue to follow-up patients who transfer between wards. Module 3 (Outcome) complete at discharge or death General Guidance: - The CRF is designed to collect data obtained through examination, interview and review of hospital notes. Data may be collected retrospectively if the patient is enrolled after the admission date. - For more detailed guidance on how to complete these forms, please refer to the CRF Completion Guideline - Participant Identification Numbers consist of a 3 digit site code and a 4 digit participant number. You can obtain a site code and registering on the data management system by contacting ISARIC. Participant numbers should be assigned sequentially for each site beginning with 0001. In the case of a single site recruiting participants on different wards, or where it is otherwise difficult to assign sequential numbers, it is acceptable to assign numbers in blocks or incorporating alpha characters. E.g. Ward X will assign numbers from 0001 or A001 onwards and Ward Y will assign numbers from 5001 or B001 onwards. Enter the Participant Identification Number at the top of every page. - Printed paper CRFs may be used for later transfer of the data onto the electronic database. - For participants who return for re-admission to the same site, start a new form with a different Participant Identification Number. Please check “YES-admitted previously” in the ONSET & ADMISSION section. Enter as 2 separate entries in the electronic database. - For participants who transfer between two sites that are both collecting data on this form, it is preferred to have the data entered by a single site as a single admission, under the same Participant Identification Number. When this is not possible, the first site should record “Transfer to other facility” as an OUTCOME, and the second site should start a new form with a new patient number and indicate “YES-transferred” in ONSET & ADMISSION. - Complete every line of every section, except for where the instructions say to skip a section based on certain responses. - Mark ‘Not done’ for any results of laboratory values that are not available, not applicable or unknown. - Avoid recording data outside of the dedicated areas. Sections are available for recording additional information. - If using paper CRFs, we recommend writing clearly in ink, using BLOCK-CAPITAL LETTERS. - Place an (X) when you choose the corresponding answer. To make corrections, strike through (-------) the data you wish to delete and write the correct data above it. Please initial and date all corrections. - Please keep all of the sheets for a single participant together e.g. with a staple or participant-unique folder. - ISARIC would like the centers to enter data directly into their electronic data capture system. Please contact ISARIC about access. If your site would like to collect data independently, ISARIC can support you in the estabilishment of locally hosted databases. This version may serve as a basis for locally hosted databases. - Please contact ISARIC, if you need help with databases, have comments or to let ISARIC know that you are using the CRF. - Please let us know if you find any mistakes in the MDM Portal's version. FURTHER GUIDANCE AND DEFINITIONS (from the Completion guideline) Comorbidities: Comorbidities present before the onset of COVID-19 and are still present. Do not include those that developed following the onset of COVID-19 symptoms. More detailed guidance is provided. Hospital admission: For patients who were admitted to hospital with COVID-19 or symptoms consistent with possible COVID-19 infection, please enter details for the date of hospital admission. For patients with a clear alternative diagnosis leading to admission who subsequently acquired COVID-19, original admission date should be provided, but all subsequent references to admission should be taken as referring to day COVID-19 was first clinically suspected (or within the first 24 hours after first day of suspected or confirmed COVID-19 infection). Where a patient was admitted via multiple hospital departments, count admission from the time they came to the first department during the visit that led to their admission (e.g. arrival at the Emergency Department). Oxygen therapy: Include any form of supplemental oxygen received using any methods. Invasive ventilation: Please include any mechanical ventilation delivered following intubation or via a tracheostomy. Do not include patients who are breathing independently via a tracheostomy. Non-invasive ventilation: Please include any positive-pressure treatment given via a tight-fitted mask. This can be continuous positive pressure (CPAP) or bi-level positive pressure (BIPAP). Renal replacement therapy or dialysis: Please include any form of continuous renal replacement therapy or intermittent haemodialysis. Worst result: References to ‘worst result’ refer to those furthest from the normal physiological range or laboratory normal range. Results that were rejected by the clinical team (e.g. pulse oximetry on poorly perfused extremities, haemolysed blood samples, contaminated microbiology results) should not be reported. The following measures should be considered as a single observation and entered together: Blood gas results: Please report the measures from the blood gas with the lowest pH (most acidotic). Blood pressure: Please report the systolic and diastolic blood pressure from the observation with the lowest mean arterial pressure (if mean arterial pressure has not been calculated, report the measurement with lowest systolic blood pressure). Respiratory rate: If both abnormal low and high rate observed, record the abnormally high rate. General information about ISARIC ISARIC has developed a portfolio of resources to accelerate outbreak research and response. All resources are designed to address the most critical public health questions, have undergone extensive review by international clinical experts, and are free to use. ISARIC should be acknowledged and informed if you implement the protocol. Ethical apporval of the protocol and all necessary operational and financial arrangements are the responsibility of the investigators. This form refers to the CoV CASE RECORD FORM Version 1.3 25 Aug 2020. See https://isaric.tghn.org/COVID-19-CRF/

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

- 06/05/21 - 1 modulo, 10 itemgroups, 48 elementi, 1 linguaggio
Itemgroups: Etiology of liver cirrhosis, Hepatic decompensation (Ascites, Variceal bleeding, Hepatic encephalopathy), Reasons of consultation / hospitalisation, Liver transplantation waiting list, Recent bacterial infection, Child-Pugh Score at Baseline, MELD Score, Acute-on-chronic liver failure during the SARS-CoV-2 infection, Recent medication, 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 liver cirrhosis sub-cohort. If a text field can't be filled out, note 'ND' (for not determined).

ISARIC/WHO Novel Coronavirus (nCoV) / COVID-19 Case Report Form - Module 2: Daily Case Report Form (CRF)

- 18/01/21 - 1 modulo, 5 itemgroups, 108 elementi, 1 linguaggio
Itemgroups: Administrative documentation, Signs and symptoms Part 1, Therapy, Signs and symptoms - Part 3, Laboratory Results
This CRF is set up in modules to be used for recording data on the ISARIC COVID-19 Core Database or for independent studies. Complete on the day of admission or first COVID-19 investigation, and on the first day of ICU admission (if different from day of admission). In addition, depending on available resources, complete every day for a maximum of 14 days, or for days when biochemical results are available. Module 1 and Module 2 complete on the first day of presentation/admission or on first day of COVID-19 assessment. Module 2 also complete on first day of admission to ICU or high dependency unit. In addition, complete daily for as many days as resources allow up to a maximum of 14 days. Continue to follow-up patients who transfer between wards. Module 3 (Outcome) complete at discharge or death General Guidance: - The CRF is designed to collect data obtained through examination, interview and review of hospital notes. Data may be collected retrospectively if the patient is enrolled after the admission date. - For more detailed guidance on how to complete these forms, please refer to the CRF Completion Guideline - Participant Identification Numbers consist of a 3 digit site code and a 4 digit participant number. You can obtain a site code and registering on the data management system by contacting ISARIC. Participant numbers should be assigned sequentially for each site beginning with 0001. In the case of a single site recruiting participants on different wards, or where it is otherwise difficult to assign sequential numbers, it is acceptable to assign numbers in blocks or incorporating alpha characters. E.g. Ward X will assign numbers from 0001 or A001 onwards and Ward Y will assign numbers from 5001 or B001 onwards. Enter the Participant Identification Number at the top of every page. - Printed paper CRFs may be used for later transfer of the data onto the electronic database. - For participants who return for re-admission to the same site, start a new form with a different Participant Identification Number. Please check “YES-admitted previously” in the ONSET & ADMISSION section. Enter as 2 separate entries in the electronic database. - For participants who transfer between two sites that are both collecting data on this form, it is preferred to have the data entered by a single site as a single admission, under the same Participant Identification Number. When this is not possible, the first site should record “Transfer to other facility” as an OUTCOME, and the second site should start a new form with a new patient number and indicate “YES-transferred” in ONSET & ADMISSION. - Complete every line of every section, except for where the instructions say to skip a section based on certain responses. - Mark ‘Not done’ for any results of laboratory values that are not available, not applicable or unknown. - Avoid recording data outside of the dedicated areas. Sections are available for recording additional information. - If using paper CRFs, we recommend writing clearly in ink, using BLOCK-CAPITAL LETTERS. - Place an (X) when you choose the corresponding answer. To make corrections, strike through (-------) the data you wish to delete and write the correct data above it. Please initial and date all corrections. - Please keep all of the sheets for a single participant together e.g. with a staple or participant-unique folder. - ISARIC would like the centers to enter data directly into their electronic data capture system. Please contact ISARIC about access. If your site would like to collect data independently, ISARIC can support you in the estabilishment of locally hosted databases. This version may serve as a basis for locally hosted databases. - Please contact ISARIC, if you need help with databases, have comments or to let ISARIC know that you are using the CRF. - Please let us know if you find any mistakes in the MDM Portal's version. FURTHER GUIDANCE AND DEFINITIONS (from the Completion guideline) Comorbidities: Comorbidities present before the onset of COVID-19 and are still present. Do not include those that developed following the onset of COVID-19 symptoms. More detailed guidance is provided. Hospital admission: For patients who were admitted to hospital with COVID-19 or symptoms consistent with possible COVID-19 infection, please enter details for the date of hospital admission. For patients with a clear alternative diagnosis leading to admission who subsequently acquired COVID-19, original admission date should be provided, but all subsequent references to admission should be taken as referring to day COVID-19 was first clinically suspected (or within the first 24 hours after first day of suspected or confirmed COVID-19 infection). Where a patient was admitted via multiple hospital departments, count admission from the time they came to the first department during the visit that led to their admission (e.g. arrival at the Emergency Department). Oxygen therapy: Include any form of supplemental oxygen received using any methods. Invasive ventilation: Please include any mechanical ventilation delivered following intubation or via a tracheostomy. Do not include patients who are breathing independently via a tracheostomy. Non-invasive ventilation: Please include any positive-pressure treatment given via a tight-fitted mask. This can be continuous positive pressure (CPAP) or bi-level positive pressure (BIPAP). Renal replacement therapy or dialysis: Please include any form of continuous renal replacement therapy or intermittent haemodialysis. Worst result: References to ‘worst result’ refer to those furthest from the normal physiological range or laboratory normal range. Results that were rejected by the clinical team (e.g. pulse oximetry on poorly perfused extremities, haemolysed blood samples, contaminated microbiology results) should not be reported. The following measures should be considered as a single observation and entered together: Blood gas results: Please report the measures from the blood gas with the lowest pH (most acidotic). Blood pressure: Please report the systolic and diastolic blood pressure from the observation with the lowest mean arterial pressure (if mean arterial pressure has not been calculated, report the measurement with lowest systolic blood pressure). Respiratory rate: If both abnormal low and high rate observed, record the abnormally high rate. General information about ISARIC ISARIC has developed a portfolio of resources to accelerate outbreak research and response. All resources are designed to address the most critical public health questions, have undergone extensive review by international clinical experts, and are free to use. ISARIC should be acknowledged and informed if you implement the protocol. Ethical apporval of the protocol and all necessary operational and financial arrangements are the responsibility of the investigators. This form refers to the CoV CASE RECORD FORM Version 1.3 25 Aug 2020. See https://isaric.tghn.org/COVID-19-CRF/

ISARIC/WHO Novel Coronavirus (nCoV) / COVID-19 Case Report Form - MODULE 1: PRESENTATION/ADMISSION CASE REPORT FORM

- 18/01/21 - 1 modulo, 10 itemgroups, 112 elementi, 1 linguaggio
Itemgroups: Participant Identification, Clinical Inclusion Criteria, Demographics, Post Partum, Infant, Onset and admission, Signs and symptoms at hospital admission, Admission signs and symptoms, Pre-admission medication, Co-morbidities and risk factors
This CRF is set up in modules to be used for recording data on the ISARIC COVID-19 Core Database or for independent studies. Module 1 and Module 2 complete on the first day of presentation/admission or on first day of COVID-19 assessment. Module 2 also complete on first day of admission to ICU or high dependency unit. In addition, complete daily for as many days as resources allow up to a maximum of 14 days. Continue to follow-up patients who transfer between wards. Module 3 (Outcome) complete at discharge or death GENERAL GUIDANCE - The CRF is designed to collect data obtained through examination, interview and review of hospital notes. Data may be collected retrospectively if the patient is enrolled after the admission date. - For more detailed guidance on how to complete these forms, please refer to the CRF Completion Guideline - Participant Identification Numbers consist of a 3 digit site code and a 4 digit participant number. You can obtain a site code and registering on the data management system by contacting ISARIC. Participant numbers should be assigned sequentially for each site beginning with 0001. In the case of a single site recruiting participants on different wards, or where it is otherwise difficult to assign sequential numbers, it is acceptable to assign numbers in blocks or incorporating alpha characters. E.g. Ward X will assign numbers from 0001 or A001 onwards and Ward Y will assign numbers from 5001 or B001 onwards. Enter the Participant Identification Number at the top of every page. - Printed paper CRFs may be used for later transfer of the data onto the electronic database. - For participants who return for re-admission to the same site, start a new form with a different Participant Identification Number. Please check “YES-admitted previously” in the ONSET & ADMISSION section. Enter as 2 separate entries in the electronic database. - For participants who transfer between two sites that are both collecting data on this form, it is preferred to have the data entered by a single site as a single admission, under the same Participant Identification Number. When this is not possible, the first site should record “Transfer to other facility” as an OUTCOME, and the second site should start a new form with a new patient number and indicate “YES-transferred” in ONSET & ADMISSION. - Complete every line of every section, except for where the instructions say to skip a section based on certain responses. - Mark ‘Not done’ for any results of laboratory values that are not available, not applicable or unknown. - Avoid recording data outside of the dedicated areas. Sections are available for recording additional information. - If using paper CRFs, we recommend writing clearly in ink, using BLOCK-CAPITAL LETTERS. Place an (X) when you choose the corresponding answer. To make corrections, strike through (-------) the data you wish to delete and write the correct data above it. Please initial and date all corrections. Please keep all of the sheets for a single participant together e.g. with a staple or participant-unique folder. - ISARIC would like the centers to enter data directly into their electronic data capture system. Please contact ISARIC about access. If your site would like to collect data independently, ISARIC can support you in the estabilishment of locally hosted databases. This version may serve as a basis for locally hosted databases. - Please contact ISARIC, if you need help with databases, have comments or to let ISARIC know that you are using the CRF. - Please let us know if you find any mistakes in the MDM Portal's version. FURTHER GUIDANCE AND DEFINITIONS (from the Completion guideline) Comorbidities: Comorbidities present before the onset of COVID-19 and are still present. Do not include those that developed following the onset of COVID-19 symptoms. More detailed guidance is provided. Hospital admission: For patients who were admitted to hospital with COVID-19 or symptoms consistent with possible COVID-19 infection, please enter details for the date of hospital admission. For patients with a clear alternative diagnosis leading to admission who subsequently acquired COVID-19, original admission date should be provided, but all subsequent references to admission should be taken as referring to day COVID-19 was first clinically suspected (or within the first 24 hours after first day of suspected or confirmed COVID-19 infection). Where a patient was admitted via multiple hospital departments, count admission from the time they came to the first department during the visit that led to their admission (e.g. arrival at the Emergency Department). Oxygen therapy: Include any form of supplemental oxygen received using any methods. Invasive ventilation: Please include any mechanical ventilation delivered following intubation or via a tracheostomy. Do not include patients who are breathing independently via a tracheostomy. Non-invasive ventilation: Please include any positive-pressure treatment given via a tight-fitted mask. This can be continuous positive pressure (CPAP) or bi-level positive pressure (BIPAP). Renal replacement therapy or dialysis: Please include any form of continuous renal replacement therapy or intermittent haemodialysis. Worst result: References to ‘worst result’ refer to those furthest from the normal physiological range or laboratory normal range. Results that were rejected by the clinical team (e.g. pulse oximetry on poorly perfused extremities, haemolysed blood samples, contaminated microbiology results) should not be reported. The following measures should be considered as a single observation and entered together: Blood gas results: Please report the measures from the blood gas with the lowest pH (most acidotic). Blood pressure: Please report the systolic and diastolic blood pressure from the observation with the lowest mean arterial pressure (if mean arterial pressure has not been calculated, report the measurement with lowest systolic blood pressure). Respiratory rate: If both abnormal low and high rate observed, record the abnormally high rate. General information about ISARIC ISARIC has developed a portfolio of resources to accelerate outbreak research and response. All resources are designed to address the most critical public health questions, have undergone extensive review by international clinical experts, and are free to use. ISARIC should be acknowledged and informed if you implement the protocol. Ethical apporval of the protocol and all necessary operational and financial arrangements are the responsibility of the investigators. This form refers to the CoV CASE RECORD FORM Version 1.3 25 Aug 2020. See https://isaric.tghn.org/COVID-19-CRF/

Clinical survey Micafungin Phase NIT

- 05/08/16 - 1 modulo, 29 itemgroups, 267 elementi, 1 linguaggio
Itemgroups: Medical History (PGID 272) , Diseases, conditions , Treatment, Indication for treatment, Treatment target, Involved sites, Risk Factors, APACHE Score, Immunosuppressants, Types of isolation, Other Antifungals BEFORE initiation, Other Antifungals AFTER initiation, Temperature, Diagnostic procedures, Sites of Mycosis, CT finding, Sites of Mycosis, MRT finding, Sites of Mycosis, Sonography finding, Sites of Mycosis, Fundoscopy finding, Sites of Mycosis, microbiological culture finding, Sites of Mycosis, Tissue specimen finding, Method of biopsy, Micafungin Treatment (PGID 280), CYP450 inductors DURING treatment, Breakthrough Infections (PGID 281), Adverse Events, Laboratory Parameters (PGID 283) , Outcome Micafungin (PGID 284) , Other Antifungal, Outcome Final Antifungal Treatment (PGID 286), Follow Up (PGID 287)
Clinical survey Micafungin Phase NIT Principal Investigator PD Dr. Jörg Janne Vehreschild, Universitätsklinikum Köln Licence:CC-BY

Follow-Up Registry for Sickle Cell Diseases

- 20/09/21 - 1 modulo, 25 itemgroups, 145 elementi, 2 lingue
Itemgroups: Patient data, Treating Clinic, General practitioner, Career path, Follow-up status, Pain crisis, Spleen sequestration, Bacterial Infections (confirmed), Cholelithiasis, Aplastic crisis, Cerebral infarction, Bone Diseases, Lower leg ulcera, Urological complications, Acute thoracic syndrome, Transfusions, Other, Medication, Clinical examination, Lab values, Transabdominal Ultrasound, Cardiological test status, Eye examination, Information needs and comments, Signature
Register für Sichelzellerkrankungen Sichel-Reg, 3. Verlaufsdokumentation Registerzentrale: Dr. Dickerhoff / Dr. Potthoff, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie, Universitätsklinikum Düsseldorf

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

- 01/07/21 - 1 modulo, 6 itemgroups, 30 elementi, 1 linguaggio
Itemgroups: Chronic pulmonary disease other than asthma and copd, Oxygen ventilation/ oxygen support before SARS-CoV-2 detection, Regular use of inhaler, Prior pulmonary function (Spirometrie) before COVID-19, Pulmonary function (Spirometrie) at diagnosis of COVID-19, 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: 21.03.2021 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 pulmonary sub-cohort. If a text field can't be filled out, note 'ND'.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Ethics and palliative care details

- 29/06/21 - 1 modulo, 8 itemgroups, 41 elementi, 1 linguaggio
Itemgroups: Reasons for change of therapeutic goals from life-prolonging to palliative, Ethics consultation, Patient declined life-prolonging measures in case of life threatening diseases, Specialist palliative care setting, Specialist palliative care type, Specialist palliative care professionals involved, Drugs prescribed for symptom control (e.g. breathlessness, pain, death rattle), 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: 21.03.2021 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 ethics and palliative care details. If a text field can't be filled out, note 'ND'.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Emergency care details

- 29/06/21 - 1 modulo, 11 itemgroups, 43 elementi, 1 linguaggio
Itemgroups: Lung ultrasound in emergency department for COVID-19 diagnosis, result, Initial therapeutic approaches for COVID-19 treatment in emergency department, respiratory / airway management in the emergency department, Oxygen inhalation, High flow nasal cannula, Mechanical ventilation settings, BIPAP settings, Mechanical ventilation: mean positive endexpiratory pressure (PEEP), Mechanical ventilation: mean fraction of inspired oxygen (FIO2), Information concerning admission at / discharge from emergency department, 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: 21.03.2021 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 Emergency care details. If a text field can't be filled out, note 'ND'.

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Fatal outcome details

- 28/06/21 - 1 modulo, 4 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Place of death, Contacts in context of death phase, Autopsy, 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: 21.03.2021 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 context of death. If a text field can't be filled out, note 'ND'.

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