At ANY time during hospitalisation, did the patient receive/undergo:
Complete this field for all patients. If the patient received any form of supplementary oxygen, via nose cannula, mask or non-invasive or invasive ventilation tick ‘yes’ and indicate the total days they received any form of oxygen (O2) therapy. If any supplemental oxygen (at any concentration) was given by any means of delivery at any point during the patient’s hospital stay, place a cross in the box marked ‘yes’. This includes any supplementary oxygen (O2) delivered via non-invasive facemasks/nasal cannula/mask or via invasive mechanical ventilation. Please also indicate the maximum O2 flow volume. If it is not possible to access record of the absolute highest O2 volume delivered during the admission indicate the highest known.
integer
Complete this field for all patients. If the patient received any form of supplementary oxygen, via nose cannula, mask or non-invasive or invasive ventilation tick ‘yes’ and indicate the total days they received any form of oxygen (O2) therapy. If any supplemental oxygen (at any concentration) was given by any means of delivery at any point during the patient’s hospital stay, place a cross in the box marked ‘yes’. This includes any supplementary oxygen (O2) delivered via non-invasive facemasks/nasal cannula/mask or via invasive mechanical ventilation. Please also indicate the maximum O2 flow volume. If it is not possible to access record of the absolute highest O2 volume delivered during the admission indicate the highest known. For all questions of duration, please count the number of calendar days that the patient received the treatment. For treatments that were stopped and restarted, count those days on which the treatment was given but don’t count any calendar days on which it was not given at all.
integer
Complete this field for all patients. If the patient received any form of supplementary oxygen, via nose cannula, mask or non-invasive or invasive ventilation tick ‘yes’ and indicate the total days they received any form of oxygen (O2) therapy. If any supplemental oxygen (at any concentration) was given by any means of delivery at any point during the patient’s hospital stay, place a cross in the box marked ‘yes’. This includes any supplementary oxygen (O2) delivered via non-invasive facemasks/nasal cannula/mask or via invasive mechanical ventilation. Please also indicate the maximum O2 flow volume. If it is not possible to access record of the absolute highest O2 volume delivered during the admission indicate the highest known.
boolean
Maximum O2 flow volume
integer
If the patient received non-invasive ventilation (NIV), defined as the provision of ventilatory support through the patient's upper airway using a mask or similar device, at any time during their hospital stay, place tick ‘yes’ and enter the total duration in days if known.
integer
If the patient received non-invasive ventilation (NIV), defined as the provision of ventilatory support through the patient's upper airway using a mask or similar device, at any time during their hospital stay, place tick ‘yes’ and enter the total duration in days if known. For all questions of duration, please count the number of calendar days that the patient received the treatment. For treatments that were stopped and restarted, count those days on which the treatment was given but don’t count any calendar days on which it was not given at all.
integer
If the patient received non-invasive ventilation (NIV), defined as the provision of ventilatory support through the patient's upper airway using a mask or similar device, at any time during their hospital stay, place tick ‘yes’ and enter the total duration in days if known.
boolean
Invasive ventilation means that patient has undergone tracheal intubation, for the purpose of invasive mechanical ventilation. Invasive ventilation is a method to mechanically assist or replace spontaneous breathing in patients by use of a powered device that forces oxygenated air into the lungs. The mode of intubation may be orotracheal, nasotracheal, or via a cricothyrotomy or tracheotomy.
integer
For all questions of duration, please count the number of calendar days that the patient received the treatment. For treatments that were stopped and restarted, count those days on which the treatment was given but don’t count any calendar days on which it was not given at all.
integer
Invasive ventilation means that patient has undergone tracheal intubation, for the purpose of invasive mechanical ventilation. Invasive ventilation is a method to mechanically assist or replace spontaneous breathing in patients by use of a powered device that forces oxygenated air into the lungs. The mode of intubation may be orotracheal, nasotracheal, or via a cricothyrotomy or tracheotomy.
boolean
Prone ventilation refers to ventilation with the patient lying in the prone position. If the patient received prone ventilation at any time during their hospital stay, please tick ‘yes’ and indicate the total duration in days.
integer
Prone ventilation refers to ventilation with the patient lying in the prone position. If the patient received prone ventilation at any time during their hospital stay, please tick ‘yes’ and indicate the total duration in days. For all questions of duration, please count the number of calendar days that the patient received the treatment. For treatments that were stopped and restarted, count those days on which the treatment was given but don’t count any calendar days on which it was not given at all.
integer
Prone ventilation refers to ventilation with the patient lying in the prone position. If the patient received prone ventilation at any time during their hospital stay, please tick ‘yes’ and indicate the total duration in days.
boolean
If the patient received inhaled nitric oxide at any time during their hospital stay, place a cross (X) in the box marked ‘yes’. If they did not, place a cross in the box marked ‘no’. If the answer is not known, place a cross in the box marked ‘N/A’.
integer
If the patient received a tracheostomy, place a cross (X) in the box marked ‘yes’. If they did not, place a cross in the box marked ‘no’. If the answer is not known, place a cross in the box marked ‘N/A’.
integer
Extracorporeal Life Support (ECLS), also known as Extracorporeal membrane oxygenation (ECMO) is a variation of cardiopulmonary bypass, it maintains tissue oxygenation for days to weeks in patients with life threatening respiratory or cardiac failure (or both). N/A’).
integer
Extracorporeal Life Support (ECLS), also known as Extracorporeal membrane oxygenation (ECMO) is a variation of cardiopulmonary bypass, it maintains tissue oxygenation for days to weeks in patients with life threatening respiratory or cardiac failure (or both). N/A’). For all questions of duration, please count the number of calendar days that the patient received the treatment. For treatments that were stopped and restarted, count those days on which the treatment was given but don’t count any calendar days on which it was not given at all.
integer
Extracorporeal Life Support (ECLS), also known as Extracorporeal membrane oxygenation (ECMO) is a variation of cardiopulmonary bypass, it maintains tissue oxygenation for days to weeks in patients with life threatening respiratory or cardiac failure (or both). N/A’).
boolean
Renal replacement therapy includes haemodialysis, peritoneal dialysis (PD), intermittent haemodialysis (IHD), on-line intermittent haemofiltration (IHF), on-line haemodiafiltration (IHDF), continuous haemofiltration (CHF) and continuous haemodiafiltration (CHDF), continuous venovenous haemofiltration (CVVH), continuous venovenous haemodialysis (CVVHD), continuous venovenous haemodiafiltration (CVVHDF), slow continuous ultrafiltration (SCUF), continuous arteriovenous haemofiltration (CAVHD) and sustained low- efficiency dialysis (SLED).
integer
A vasopressor is a pharmaceutical agent that causes vasoconstriction. Agents include norepinephrine, epinephrine, vasopressin, terlipressin and phenylephrine. An inotrope is a pharmaceutical agent that alters the force of myocardial contractility. Commonly used ‘positive’ inotropes include dobutamine, dopamine, milrinone and adrenaline (epinephrine). If the patient received a vasopressor or inotrope for at least one hour during their hospital stay, place tick ‘yes’ and the total duration in days if known.
integer
A vasopressor is a pharmaceutical agent that causes vasoconstriction. Agents include norepinephrine, epinephrine, vasopressin, terlipressin and phenylephrine. An inotrope is a pharmaceutical agent that alters the force of myocardial contractility. Commonly used ‘positive’ inotropes include dobutamine, dopamine, milrinone and adrenaline (epinephrine). If the patient received a vasopressor or inotrope for at least one hour during their hospital stay, place tick ‘yes’ and the total duration in days if known. For all questions of duration, please count the number of calendar days that the patient received the treatment. For treatments that were stopped and restarted, count those days on which the treatment was given but don’t count any calendar days on which it was not given at all.
integer
A vasopressor is a pharmaceutical agent that causes vasoconstriction. Agents include norepinephrine, epinephrine, vasopressin, terlipressin and phenylephrine. An inotrope is a pharmaceutical agent that alters the force of myocardial contractility. Commonly used ‘positive’ inotropes include dobutamine, dopamine, milrinone and adrenaline (epinephrine). If the patient received a vasopressor or inotrope for at least one hour during their hospital stay, place tick ‘yes’ and the total duration in days if known.
boolean
Place a cross (X) in the appropriate box: yes, (if admitted) or no (if this is not the case).
integer
Please enter the total number of days the patient was admitted to the ICU/HDU, this should include all ICU/HDU admissions if there were more than one. Count any day in which the patient was in ICU/HDU during that 24 hour period (please note this number could be significantly shorter than indicated by the two dates indicated in the first and last day field if the patient was discharged to another ward/unit and readmitted to the ICU/HDU during their hospital stay). For all questions of duration, please count the number of calendar days that the patient received the treatment. For treatments that were stopped and restarted, count those days on which the treatment was given but don’t count any calendar days on which it was not given at all.
integer
Please enter the total number of days the patient was admitted to the ICU/HDU, this should include all ICU/HDU admissions if there were more than one. Count any day in which the patient was in ICU/HDU during that 24 hour period (please note this number could be significantly shorter than indicated by the two dates indicated in the first and last day field if the patient was discharged to another ward/unit and readmitted to the ICU/HDU during their hospital stay).
boolean
Date of most recent admission from ICU/ HDU. This section may need to be revised if the patient has more than one ICU/HDU admission during a single hospital admission.
date
If the answer is YES, please indicate the date on which the patient was first admitted to the intensive care unit / High Dependence Unit (ICU/HDU).
boolean
Date of most recent discharge from ICU/ HDU. This section may need to be revised if the patient has more than one ICU/HDU admission during a single hospital admission.
date
Date of most recent discharge from ICU/ HDU. This section may need to be revised if the patient has more than one ICU/HDU admission during a single hospital admission.
date
At any time during hospitalisation did the patient experience
Clinically or radiologically diagnosed viral pneumonitis/pneumonia. For all items in this group: Please select all that were clinically identified at any time during the hospital admission. Do not include known comorbidities (e.g. previous atrial fibrillation should not be included but new onset during this admission should). Record physician diagnosed complications.
integer
Clinically or radiologically diagnosed bacterial pneumonia (including community, hospital and ventilator acquired) managed with antimicrobials. Bacteriological confirmation not required.
integer
Defined according to Berlin criteria as: - Occurring within 1 week of a known clinical insult or worsening respiratory symptoms - Bilateral radiological opacities not fully explained by effusions, lobar/lung collapse, or nodules - Respiratory failure not fully explained by cardiac failure or fluid overload
integer
Defined according to Berlin criteria as: - Occurring within 1 week of a known clinical insult or worsening respiratory symptoms - Bilateral radiological opacities not fully explained by effusions, lobar/lung collapse, or nodules - Respiratory failure not fully explained by cardiac failure or fluid overload The severity of the hypoxaemia defines the severity of the ARDS: Mild ARDS: The PaO2/FiO2 is >200 mmHg, but ≤300 mmHg, on ventilator settings that include positive end- expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥5 cm H2O. Moderate ARDS: The PaO2/FiO2 is >100 mmHg, but ≤200 mmHg, on ventilator settings that include PEEP ≥5 cm H2O. Severe ARDS: The PaO2/FiO2 is ≤100 mmHg on ventilators setting that include PEEP ≥5 cm H2O. To determine the PaO2/FiO2 ratio, the PaO2 is measured in mmHg and the FiO2 is expressed as a decimal between 0.21 and 1. As an example, if a patient has a PaO2 of 60 mmHg while receiving 60% oxygen, then the PaO2/FiO2 is 60/0.6 = 100 mmHg.
integer
Is defined as the abnormal presence of air in the pleural cavity (between the lungs and the chest wall), causing collapse of the lung. It may be diagnosed clinically, usually with radiological confirmation.
integer
Is defined as increased amounts of fluid within the pleural cavity. It may be diagnosed clinically, with or without radiological or interventional confirmation.
integer
Idiopathic diffuse interstitial lung disease, diagnosed radiologically (multiple consolidative or ground glass opacities) or histologically (granulation tissue and chronic inflammatory infiltrate in alveoli). Formerly known as bronchiolitis obliterans organizing pneumonia (BOOP)
integer
This is a clinical diagnosis.
integer
Sudden cessation of cardiac activity with no normal breathing and no signs of circulation.
integer
Myocardial ischaemia (MI) leading to injury/necrosis, diagnosed by clinical findings, altered electrocardiography and elevated cardiac enzymes.
integer
Is defined as diminished blood and oxygen supply to the heart muscle, also known as myocardial ischemia, It is confirmed by an electrocardiogram (showing ischaemic changes, e.g. ST depression or elevation) and/or cardiac enzyme elevation.
integer
If a cardiac arrhythmia is identified and there is no previous record of it, select ‘yes’.
integer
Myocarditis / pericarditis refers to an inflammation of the heart or pericardium (outer lining of the heart). Diagnosis can be clinical, biochemical (cardiac enzymes) or radiological.
integer
Endocarditis is an inflammation of the endocardium (inner lining of the heart). Diagnosis is according to modified Duke criteria, using evidence from microbiological results, echocardiogram and clinical signs.
integer
Structural and functional disorders of myocardium commonly diagnosed by echocardiography. Can be primary (genetic) or secondary (e.g. following myocardial infarction).
integer
Is defined as failure of the heart to pump a sufficient amount of blood to meet the needs of the body tissues, resulting in tissue congestion and oedema.
integer
Select ‘yes’ for any seizure regardless of cause (e.g. febrile or due to epilepsy)
integer
Stroke may be a clinical diagnosis, with or without supportive radiological findings.
integer
Inflammation of the meninges or the brain parenchyma. Select yes if diagnosed clinically, radiologically or microbiologically.
integer
Growth of bacteria on a blood culture. Select ‘no’ if the only bacteria grown were believed to be skin contaminants (e.g. coagulase negative Staphylococci or diphtheroids).
integer
Abnormal coagulation identified by abnormal prothrombin time or activated partial thromboplastin time. Disseminated intravascular coagulation (DIC; consumption coagulopathy; defibrination syndrome) is defined by thrombocytopenia, prolonged prothrombin time, low fibrinogen, elevated D-dimer and thrombotic microangiopathy.
integer
Obstruction of pulmonary artery by thrombus, air or fat. Physician diagnosis based on clinical signs, computed tomographic pulmonary angiography and/or ventilation/perfusion scanning.
integer
Select ‘yes’ if haemoglobin levels were lower than age- and sex-specific thresholds listed in https://media.tghn.org/medialibrary/2020/04/ISARIC_nCoV_CRF_Completion_Guide_V1.3_24Feb2020.pdf (Page 15 of 22)
integer
Rhabdomyolysis is a syndrome characterised by muscle necrosis and the release of myoglobin into the blood. Muscle biopsy, electromyography, radiological imaging and the presence of myoglobinuria are not required for the diagnosis. Myositis may be a clinical diagnosis with supporting evidence from laboratory tests e.g. elevated serum creatine kinase; histological confirmation is not required to make the diagnosis. Myositis can occur without progression to rhabdomyolysis.
integer
Acute renal injury is defined as any of: - Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours - Increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days - Urine volume <0.5 mL/kg/hour for 6 hours
integer
Refers to bleeding originating from any part of the gastrointestinal tract (from the oropharynx to the rectum).
integer
Inflammation of the pancreas, diagnosed from clinical, biochemical, radiological or histological evidence.
integer
A finding that indicates abnormal liver function, may refer to any of the following: - Clinical jaundice - Hyperbilirubinaemia (blood bilirubin level twice the upper limit of the normal range) - An increase in alanine transaminase or aspartate transaminase that is twice the upper limit of the normal range
integer
For adults, is defined as an abnormally high level of glucose in the blood, blood glucose level that is consistently above 126mg/dL or 7 mmol/L. For children, is defined as a blood glucose level consistently above 8.3 mmol/L.
integer
For adults, is defined as an abnormally low level of glucose in the blood, a blood glucose level that is consistently below 70mg/dL or 4 mmol/L. For children, is defined as a blood glucose level below 3 mmol/L.
integer
Please specify other complications in the space provided.
integer
Other Complications Specification
text
Diagnostics
Please record if the patient was clinically diagnosed with COVID-19, even if resources did not allow testing or if laboratory results were negative but the clinician judged that based on symptoms, onset and clinical case definitions COVID-19 infection was the most likely cause of the symptoms experienced. Please complete all of the Diagnostics section even if results were negative, to monitor co-infection risk and rates.
integer
If laboratory testing was done, complete the section Select YES – Confirmed if the test was positive, Yes – Probable if there was a clinical diagnosis but no positive lab test and NO if the lab test was negative. If the lab test was not done or there is no clinical diagnosis please leave blank.
integer
If patient diagnosed with COVID-19 either confirmed or probable per definition above mark an 'X' in the box for Novel CoV.
integer
If patient diagnosed with COVID-19 either confirmed or probable per definition above mark an 'X' in the box for Novel CoV.
integer
Other Coronavirus Subtype
text
Influenza
integer
Influenza subtype
integer
Other Influenza subtype
text
RSV
integer
Adenovirus
integer
Bacteria
integer
Bacteria specification
text
Bacteria specimen unknown
boolean
Other pathogen/s detected
integer
Other pathogen/s detected - specification
text
Other pathogen/s detected - specimen unknown
boolean
Tick ‘yes’ f this was a Physician diagnosis.
integer
Record if X-ray and/or CT were performed, even if no infiltrates were present.
integer
Chest X-Ray: infiltrates present
integer
Record if X-ray and/or CT were performed, even if no infiltrates were present.
integer
CT performed: infiltrates present
integer
Biospecimen Testing
Collection Date
date
If the patient had samples taken for pathogen detection testing during their hospital stay, please complete a row for every type of sample collected (e.g. nasal/NP swab, sputum, etc.). Where both positive and negative results for a particular sample type exist (from samples taken at different time points during the patient’s hospital stay) please record the earliest positive result. If only multiple negative results exist for a particular sample type (from samples taken at different time points during the patient’s hospital stay), please document the earliest negative result.
text
Other Biospecimen Type
text
Laboratory test Method
integer
Other laboratory test method
text
Laboratory Test Result
integer
Pathogen Tested/Detected
text
Medication: While hospitalised or at discharge, were any of the following administered? Antiviral therapy
Record all antivirals administered from date of admission or during the hospitalisation. Record the total number of days the treatment was given. For other antiviral or COVID-19 targeted agents record any medications given to treat COVID-19 that are not already pre-specified elsewhere in this section. Additional space is available under ‘Other treatments...’ at the end of this section if required.
integer
Antiviral agents administered
integer
Other Antiviral agent
text
Antiviral agent - Start date
date
‘Antiviral Agent’ refers to any agent(s) prescribed to treat or prevent viral infections by interfering with the viral replication cycle. If the patient received antivirals at any time during their hospital stay, place a cross in the box marked ‘yes’ and also indicate the type of antiviral agent.
integer
Antiviral treatment duration unknown
boolean
Medication: While hospitalised or at discharge, were any of the following administered? Antibiotic therapy
‘Antibiotic’ refers to any agent(s) are substances naturally produced by microorganisms or their derivatives that selectively target microorganisms. These substances are used in the treatment of bacterial and other microbial infections. Topical preparations are not included.
integer
‘Antibiotic’ refers to any agent(s) are substances naturally produced by microorganisms or their derivatives that selectively target microorganisms. These substances are used in the treatment of bacterial and other microbial infections. Topical preparations are not included.
text
Antibiotic therapy - Date commenced
date
Antibiotic therapy - duration
integer
Antibiotic therapy duration unknown
boolean
While hospitalised or at discharge, were any of the following administered? Corticosteriods
‘Corticosteroids’ (commonly referred to as ‘steroids’) refers to all types of therapeutic corticosteroid, made in the adrenal cortex (the outer part of the adrenal gland). They are also made in the laboratory. Examples include: prednisolone, prednisone, methyl- prednisolone, dexamethasone, hydrocortisone, fluticasone, betamethasone (note that other examples exist). Topical preparations are not included, but inhaled preparations are included. The indication for administering corticosteroids does not need to be directly related to the treatment of COVID-19.
integer
Corticosteroid: oral route of administration
boolean
Corticosteroid: intravenous route of administration
boolean
Corticosteroid: inhaled route of administration
boolean
Corticosteroid: unknown route of administration
boolean
Oral oder IV Corticosteroid: agent
text
Oral oder IV Corticosteroid: dosage and unit
text
Corticosteroid - Start date
date
Corticosteroid - Start date unknown
boolean
Corticosteroid therapy duration
integer
Corticosteroid therapy duration unknown
boolean
Medication: While hospitalised or at discharge, were any of the following administered? Heparin
Heparin
integer
Heparin - Subcutaneous route of administration
boolean
Heparin - Intravenous (IV) route of administration
boolean
Heparin - unknown route of administration
boolean
Unfractionated heparin
boolean
Heparin type - Low molecular weight
boolean
Fondaparinux
boolean
Heparin type unknown
boolean
Heparin dosage and unit
text
Heparin - Start date
date
Heparin - Start date unknown
boolean
Heparin therapy duration
integer
Heparin therapy duration unknown
boolean
Medication: While hospitalised or at discharge, were any of the following administered? Antifungal therapy
‘Antifungal agent’ refers to any agent(s) prescribed specifically to treat systemic or topical infections caused by fungi. Examples include fluconazole, amphotericin, caspofungin, anidulafungin, posaconazole, itraconazole (note that other examples exist). Topical preparations should not be recorded.
integer
Medication: While hospitalised or at discharge, were any of the following administered? Other treatments administered for COVID-19
Record any other medications, experimental or re-purposed, administered to modify the course of COVID-19 during the admission (including as part of a clinical trial). This could include convalescent plasma, immuno-modulatory agents and anti-viral agents not already recorded above.
integer
Other treatments administered for COVID-19
text
Other treatment for COVID-19: dosage and unit
text
Other treatment for COVID-19: Date of commencement
date
Other treatment for COVID-19: Date of commencement known
boolean
Other treatment for COVID-19: Duration of therapy
integer
Other treatment for COVID-19: Duration of therapy known
boolean
Outcome
Discharged alive can mean discharge to their usual place of residence before their illness, to the home of a relative or friend, or to a social care facility, because their illness is no longer severe enough to warrant treatment in a medical facility. Hospitalized means they are still in hospital but have recovered from COVID-19 infection and the form has been completed as the patient is in a part of the hospital for care of other conditions and where the form will not be completed at a later date. Transfer to other facility means they have been transferred to another facility that provides medical care. This could be a specialist centre for more intensive treatment or a step-down for rehabilitation. It does not include facilities that solely provide social care (these patients should be listed as discharged alive). Death means the patient died in the hospital. Palliative discharge means the patient has been discharged with the expectation that they will not recover from this or other co-existing illness. This could be to a specialist hospice facility, or to their usual home address with anticipatory end of life medications.
integer
Please state the date for the outcome listed above.
date
Please state the date for the outcome listed above.
boolean
Ability to self-care at discharge versus before illness: the patient is able to care for themselves at discharge (in terms of activities of daily living) at the same level as before they developed illness then tick ‘same as before illness’. If their ability to self-care has decreased or increased, then tick the appropriate circle (‘worse’ or ‘better’).
integer
(Complete this section only if the patient is alive) Oxygen therapy includes, NIV or home ventilation (respiratory support/treatment).
integer