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LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Complementary and integrative medicine (CIM) details

- 1/5/21 - 1 formulario, 10 itemgroups, 74 items, 1 idioma
Itemgroups: Type of CIM in uncomplicated phase, Type of CIM in complicated phase, Type of CIM in critical phase, Type of CIM in recovery phase, Other type of CIM, Food supplements: Before SARS-CoV-2 detection, Food supplements: After SARS-CoV detection, Application type of CIM intervention, Lifestyle interventions, 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 Complementary and integrative medicine (CIM) details. If a text field can't be filled out, note 'ND' (for not determined).

LEOSS: Lean European Open Survey on SARS-CoV-2 Infected Patients - Apheresis therapy details

- 26/4/21 - 1 formulario, 4 itemgroups, 11 items, 1 idioma
Itemgroups: Type of apheresis therapy, Apharesis start in disease phase, Apharesis treatment details, 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 Apheresis therapy details. If a text field can't be filled out, note 'ND' (for not determined).

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

- 24/4/21 - 1 formulario, 13 itemgroups, 55 items, 1 idioma
Itemgroups: HIV transmission risk, Current antiretroviral therapy, Antiretroviral therapy duration before SARS-CoV-2 detection, Antiretroviral therapy changed / started during SARS-Cov-2 infection, Antiretroviral therapy regimen at end of follow-up period, CD4+ T-cell count (abs.), CD4+ T-cell count (rel.), HIV CDC stage at baseline, CD8+ T-cell count (abs.), CD8+ T-cell count (rel.), HIV viral load, Opportunistic infections, AIDS-defining illnesses, STI during 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: 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 HIV sub-cohort. All questions refer to the day of diagnosis (diagnosis means first positive virus result). Please note that only cases with known outcome are collected at LEOSS! If a text field can't be filled out, note 'ND' (for not determined).

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

- 24/4/21 - 1 formulario, 4 itemgroups, 44 items, 1 idioma
Itemgroups: Rheumatic disease, Organ manifestations, Rheumatic disease duration, 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 rheumatological sub-cohort. All questions refer to the day of diagnosis (diagnosis means first positive virus result). Please note that only cases with known outcome are collected at LEOSS! If a text field can't be filled out, note 'ND' (for not determined)

ISARIC/WHO Novel Coronavirus (nCoV) / COVID-19 Case Report Form - COVID-19 Case Report Form Rapid Critical Care Module - Part B

- 18/2/21 - 1 formulario, 6 itemgroups, 96 items, 1 idioma
Itemgroups: Participant Identification Numbers, ICU/HDU Admission Form, Reason for ICU admission, Fraility and renal failure, Daily form, Current treatment
To be completed for patients receiving critical care on whom the data below are available, together with the RAPID CRF. RAPID COVID-19 CRF users: - Sites should select whether they complete Part A only or both Parts A & B where resources allows. - In addition always complete the RAPID CRF Module 1 on day of admission to the hospital. For patients receiving critical care complete: - Part A - Complete on every day for patients receiving critical care beginning on the day of admission to an intensive care / high dependency unit, or on the first day of deterioration to severe disease in any ward where the data below is available. Complete daily for as many days as resources allow. In addition, complete the RAPID CRF Module 2 (Daily Form). - Part B - Complete Section 1 on the day of admission to an intensive care / high dependency unit. Complete Section 2 every day during critical care. In addition, complete the RAPID CRF Module 2 (Daily Form). - Complete the RAPID CRF Module 3 on death or hospital discharge for all patients.

ISARIC/WHO Novel Coronavirus (nCoV) / COVID-19 Case Report Form - COVID-19 Case Report Form Rapid Critical Care Module - Part A

- 18/2/21 - 1 formulario, 3 itemgroups, 34 items, 1 idioma
Itemgroups: Participant Identification Numbers, Current treatment, Signs and Symptoms
To be completed for patients receiving critical care on whom the data below are available, together with the RAPID CRF. RAPID COVID-19 CRF users: - Sites should select whether they complete Part A only or both Parts A & B where resources allows. - In addition always complete the RAPID CRF Module 1 on day of admission to the hospital. For patients receiving critical care complete: - PART A - Complete on every day for patients receiving critical care beginning on the day of admission to an intensive care / high dependency unit, or on the first day of deterioration to severe disease in any ward where the data below is available. Complete daily for as many days as resources allow. In addition, complete the RAPID CRF Module 2 (Daily Form). - PART B - Complete Section 1 on the day of admission to an intensive care / high dependency unit. Complete Section 2 every day during critical care. In addition, complete the RAPID CRF Module 2 (Daily Form). - Complete the RAPID CRF Module 3 on death or hospital discharge for all patients.

ISARIC/WHO Novel Coronavirus (nCoV) / COVID-19 Case Report Form - COVID-19 Case Report Form – Pregnancy Module

- 10/2/21 - 1 formulario, 6 itemgroups, 113 items, 1 idioma
Itemgroups: Participant Identification, Q1. Status on admission, Q2. Previous obstetric history, Q3. Delivery, Were any of the following samples tested?, Q4. Neonate Details (If multiple pregnancy complete Q4 for each baby)
This Case Report Form (CRF) is to be used together with the Core CRF or the RAPID CRF, to collect additional data to characterise COVID-19 infection in pregnancy. The form can be completed prospectively or retrospectively. The main or rapid COVID-19 CRF needs to be completed as well, using the same patient ID. Inclusion criteria: Pregnant woman with suspected or confirmed COVID-19. More information can be found at https://isaric.org/research/covid-19-clinical-research-resources/optional-crf-modules/

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

- 18/1/21 - 1 formulario, 5 itemgroups, 108 items, 1 idioma
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

- 18/1/21 - 1 formulario, 10 itemgroups, 112 items, 1 idioma
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/

FFPAgainstCOVID - F.1

- 28/10/20 - 1 formulario, 1 itemgroup, 19 items, 1 idioma
Itemgroup: FragenPerson
Coronaplasma Project, at the University of Münster. Online Screening. To be eligible, the first three questions (age, health, weight) need to be answered with yes and the rest with no. Local ethics committee approval: AZ 2020-220-f-S

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