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

- 9/20/21 - 1 form, 12 itemgroups, 138 items, 1 language
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/

Multisystem inflammatory syndrome (MIS) in children and adolescents temporally related to COVID-19 - MODULE 2: OUTCOME CASE REPORT FORM

- 8/11/21 - 1 form, 7 itemgroups, 195 items, 1 language
Itemgroups: Participant Identification, Summary of clinical features of current illness, Laboratory results, Imaging and pathogen testing, Treatment, Supportive care, Outcome
Preliminary case definition Children and adolescents 0–19 years of age with measured or self-reported fever ≥ 3 days AND two or more of the following: a) Rash or bilateral non-purulent conjunctivitis or muco-cutaneous inflammation signs (oral, hands or feet) b) Hypotension or shock c) Features of myocardial dysfunction, or pericarditis, or valvulitis, or coronary abnormalities (clinical features, ECHO findings, or laboratory markers such as elevated Troponin/NT-proBNP) d) Evidence of coagulopathy (such as abnormal PT, PTT, elevated d-Dimers) e) Acute gastrointestinal problems (such as diarrhoea, vomiting or abdominal pain) AND Elevated markers of inflammation such as ESR, C-reactive protein or procalcitonin AND No other obvious microbial cause of inflammation, including bacterial sepsis, staphylococcal or streptococcal shock syndromes AND Evidence of current or previous COVID-19 (RT-PCR, antigen test or serology positive) or likely contact with patients with COVID NB Consider this syndrome in children with features of typical or atypical Kawasaki disease or toxic shock syndrome. Based on CRF on https://isaric.org/research/covid-19-clinical-research-resources/multisystem-inflammatory-syndrome-mis-c/ This Case Report Form (CRF) has been developed by ISARIC in cooperation with WHO's working group (https://www.who.int/news-room/commentaries/detail/multisystem-inflammatory-syndrome-in-children-and-adolescents-with-covid-19) to use as a standalone CRF for children and adolescents presenting with syndrome of suspected Multisystem Inflammatory Syndrome (MIS-C). This Module is to be completed at time of discharge or death.

Multisystem inflammatory syndrome (MIS) in children and adolescents temporally related to COVID-19 - MODULE 1: PRESENTATION/ADMISSION CASE REPORT FORM

- 8/3/21 - 1 form, 10 itemgroups, 188 items, 1 language
Itemgroups: Participant Identification, Demographics, Onset of current illness and vital signs, Possible signs and symptoms of multisystem inflammatory syndrome, Other signs and symptoms of multisystem inflammatory syndrome, Recent history, Co-morbidities, past history, Pre-admission and chronic medication, Laboratory results, Imaging and pathogen testing
Based on CRF on https://isaric.org/research/covid-19-clinical-research-resources/multisystem-inflammatory-syndrome-mis-c/ This Case Report Form (CRF) has been developed by ISARIC in cooperation with WHO's working group (https://www.who.int/news-room/commentaries/detail/multisystem-inflammatory-syndrome-in-children-and-adolescents-with-covid-19) to use as a standalone CRF for children and adolescents presenting with syndrome of suspected Multisystem Inflammatory Syndrome (MIS-C). Preliminary case definition Children and adolescents 0–19 years of age with measured or self-reported fever ≥ 3 days AND two or more of the following: a) Rash or bilateral non-purulent conjunctivitis or muco-cutaneous inflammation signs (oral, hands or feet) b) Hypotension or shock c) Features of myocardial dysfunction, or pericarditis, or valvulitis, or coronary abnormalities (clinical features, ECHO findings, or laboratory markers such as elevated Troponin/NT-proBNP) d) Evidence of coagulopathy (such as abnormal PT, PTT, elevated d-Dimers) e) Acute gastrointestinal problems (such as diarrhoea, vomiting or abdominal pain) AND Elevated markers of inflammation such as ESR, C-reactive protein or procalcitonin AND No other obvious microbial cause of inflammation, including bacterial sepsis, staphylococcal or streptococcal shock syndromes AND Evidence of current or previous COVID-19 (RT-PCR, antigen test or serology positive) or likely contact with patients with COVID NB Consider this syndrome in children with features of typical or atypical Kawasaki disease or toxic shock syndrome. This Module is to be completed when multisystem inflammatory syndrome is suspected, on admission or in-patients.

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

- 1/18/21 - 1 form, 5 itemgroups, 108 items, 1 language
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

- 1/18/21 - 1 form, 10 itemgroups, 112 items, 1 language
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/

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