Us-who International Clinical Network Ebola Virus Diseas

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Overview

US-WHO Clinical Network Cover
1 Demographics and Background
2 First Signs and Symptoms
3 Signs, Symptoms on Admission
4 Signs, Symptoms Admission (2)
5 Clinical Findings
6 Interventions
7 Treatments
8 Investigational Therapies
9 Admission Labs Final Hospital
10 Labs Final Hospital
11 Virology& Immunology results
12 Outomes

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Sheet 1: US-WHO Clinical Network Cover

US-WHO INTERNATIONAL CLINICAL NETWORK EBOLA VIRUS DISEASE CLINICAL DATA COLLECTION TOOL

The data collection instrument collect data from 12 different domains including:

·         Demographics and Background

·         First Signs and Symptoms

·         Signs and symptoms at first admission (generally in Africa)

·         Signs and symptoms at second admission (generally following medical evacuation)

·         Clinical findings during hospitalization

·         Interventions employed during hospitalization

·         Treatments employed

·         Investigational Therapeutics given

·         Admission laboratory values (from final admission)

·         Laboratory testing during hospitalization

·         Virology and Immunology laboratory results

·         Outcomes

Detailed demographic and clinical information is vital to gaining insights about your center's experience caring for Ebola patients.

In order to protect patient privacy, please deliver the completed form to the CDC via the secure encrypted file transfer protocol (FTP)

using your unique SFTP address and password. Only your center and the CDC will be able to view and download your forms.

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Sheet 2: 1 Demographics and Background

Demographics and Background

Patient number (Facility name and number, for example, Emory 1, Emory 2, etc…)

Clinical location (Country of final care)

Clinical location (City in Europe or US of final care)

Patient AGE in YEARS

GENDER Male/ Female

Chronic co-morbidities (None, or provide list of all co-morbidities)

Country where EBOV infection was confirmed (RT-PCR+ for EBOV)

Country where EBOV exposure/infection occurred

Date of symptom onset

Time (days) from illness onset to diagnosis of EBOV infection by RT-PCR

Time (days) from illness onset to FIRST hospital admission

Time (days) from illness onset to FINAL hospital admission

Medically-evacuated from West Africa (YES/NO)

For Medically evacuated patients, time (days) from illness onset to admission at receiving hospital outside of West Africa

If Medevac, by whom? (Phoenix Air, Medic Air)

Imported EVD case (not medically evacuated) (YES/NO)?

Locally-acquired (secondary nosocomial transmission in Europe or US) (YES/NO?)

Occupation (physician, nurse, laboratorian, pharmacist, other healthcare professional, other (specify))

Worked in Ebola treatment unit (YES/NO)?

Worked in Healthcare facility (but not an Ebola treatment unit) (YES/NO)?

Location of FIRST hospital admission (Country 1st Hospital)?

Location of FINAL hospital admission (Country FINAL Hospital)?

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Sheet 3: 2 First Signs and Symptoms

Signs and symptoms PRIOR TO ADMISSION

Patient number

Feverishness (temperature not measured (YES/NO)?

Fever (measured elevated temperature) (YES/NO)?

How measured? (axillary, oral, rectal)

Headache (YES/NO)?

Weakness (YES/NO)?

Fatigue (YES/NO)?

Lethargy (YES/NO)?

Muscle aches (YES/NO)?

Decreased appetite (YES/NO)?

Nausea (YES/NO)?

Vomiting (YES/NO)?

Diarrhea (YES/NO)?

Abdominal pain (YES/NO)?

Sore throat (YES/NO)?

Nasal congestion (YES/NO)?

Rhinorrhea (YES/NO)?

Cough (YES/NO)?

Joint aches (YES/NO)?

Any treatments given PRIOR TO HOSPITALIZATION? (YES/ NO)

Antimalarials (please list)

Antibiotics (please list)

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Sheet 4: 3 Signs, Symptoms on Admission

Signs and symptoms present on day of Admission to Initial Hospital

General signs/ symptoms

Gastrointestinal tract

Respiratory tract

Neurological

Hemorrhagic manifestations

Mental Health

Patient number

Date of admission to initial hospital

Feverishness (temperature not measured (YES/NO)?

Fever (measured elevated temperature) (YES/NO)?

Admission temperature (Celsius)

Temperature measured by: temporal, ocular, oral, rectal, axillary?

Headache (YES/NO)?

Weakness (YES/NO)?

Fatigue (YES/NO)?

Lethargy (YES/NO)?

Muscle aches (YES/NO)?

Jaundice (YES/NO)?

Rash (YES/NO)?

Joint pain (YES/NO)?

Joint aches (YES/NO)?

Conjunctival injection (YES/NO)?

Hiccups (YES/NO)?

Decreased appetite (YES/NO)?

Nausea (YES/NO)?

Vomiting (YES/NO)?

Diarrhea (YES/NO)?

Abdominal pain (YES/NO)?

Sore throat (YES/NO)?

Pharyngitis (YS/NO)?

Glossitis (tongue inflammation) (YES/NO)?

Nasal congestion (YES/NO)?

Rhinorrhea (YES/NO)?

Cough (YES/NO)?

Hemoptysis (YES/NO)?

Shortness of breath (YES/NO)?

Difficulty breathing (YES/NO)?

Tachypnea (YES/NO)?

Oxygen saturation (pulse oximetry on room air) (%)

Altered Mental Status or Confusion (YES/NO)?

Agitation (YES/NO)?

Unresponsive, coma (YES/NO)?

Epistaxis - bleeding from nose (YES/NO)?

Bleeding from gingiva, or inside mouth (YES/NO)?

Petechiae anywhere (YES/NO)?

Hematemesis (YES/NO)?

Melena (YES/NO)?

Hematochezia - frank blood in stool (YES/NO)?

Bloody diarrhea (YES/NO)?

Oozing from IV catheter site (YES/NO)?

Anxiety (YES/NO)?

Depression (YES/NO)?

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Sheet 5: 4 Signs, Symptoms Admission (2)

Signs and symptoms present on day of Admission to FINAL Hospital

General signs/ symptoms

Gastrointestinal tract

Respiratory tract

Neurological

Hemorrhagic manifestations

Mental Health

Patient number

Date of admission to final hospital

Feverishness (temperature not measured (YES/NO)?

Fever (measured elevated temperature) (YES/NO)?

Admission temperature (Celsius)

Temperature measured by: temporal, ocular, oral, rectal, axillary?

Headache (YES/NO)?

Weakness (YES/NO)?

Fatigue (YES/NO)?

Lethargy (YES/NO)?

Muscle aches (YES/NO)?

Jaundice (YES/NO)?

Rash (YES/NO)?

Joint pain (YES/NO)?

Joint aches (YES/NO)?

Conjunctival injection (YES/NO)?

Hiccups (YES/NO)?

Decreased appetite (YES/NO)?

Nausea (YES/NO)?

Vomiting (YES/NO)?

Diarrhea (YES/NO)?

Abdominal pain (YES/NO)?

Sore throat (YES/NO)?

Pharyngitis (YS/NO)?

Glossitis (tongue inflammation) (YES/NO)?

Nasal congestion (YES/NO)?

Rhinorrhea (YES/NO)?

Cough (YES/NO)?

Hemoptysis (YES/NO)?

Shortness of breath (YES/NO)?

Difficulty breathing (YES/NO)?

Tachypnea (YES/NO)?

Oxygen saturation (pulse oximetry on room air) (%)

Altered Mental Status or Confusion (YES/NO)?

Agitation (YES/NO)?

Unresponsive, coma (YES/NO)?

Epistaxis - bleeding from nose (YES/NO)?

Bleeding from gingiva, or inside mouth (YES/NO)?

Petechiae anywhere (YES/NO)?

Hematemesis (YES/NO)?

Melena (YES/NO)?

Hematochezia - frank blood in stool (YES/NO)?

Bloody diarrhea (YES/NO)?

Oozing from IV catheter site (YES/NO)?

Anxiety (YES/NO)?

Depression (YES/NO)?

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Sheet 6: 5 Clinical Findings

Clinical Findings During Hospitalization in Europe or US

Patient number

Number of days of fever (Temp >38C)?

Number of days of diarrhea?

Maximum number of stools/day

Maximum diarrhea volume/24 hours (in mls)

Number of days of vomiting?

Bleeding or oozing at IV catheter sites (YES/NO)?

Oliguria (YES/NO) (<500 ml urine/day)?

Anuria (YES/NO)(<100 ml urine/day)?

Hypoxia (YES/NO)? (if YES, list lowes pulse oximetry on room air)?

Hypoxemia (YES/NO)? (If YES, list PaO2)

Pulmonary edema (by CXR)? (YES/NO)?

Pulmonary edema (by ultrasound)? (YES/NO)?

Pneumonia (by CXR)? (YES/NO)

Bilateral pneumonia (YES/NO)?

Unilateral pneumonia (YES/NO)?

Pulmonary edema by ultrasound (YES/NO)?

Respiratory failure (YES/NO)?

Date/ day of illness when this was diagnosed?

Hypoxemic respiratory failure (YES/NO)?

Hypercarbic respiratory failure (YES/NO)?

Acute Respiratory Distress Syndrome (ARDS) (YES/NO)?

PaO2/FIO2 (lowest)

ECG changes (YES/NO)?

If yes, what?

Arrythmia (YES/NO)?

If arrhythmia, what rhythm?

Date/ day of illness when this was diagnosed?

Suspected or documented ileus (YES/NO)?

Date/ day of illness when this was diagnosed?

Suspected or documented colon obstruction (YES/NO)?

Suspected or documented intestinal paresis (YES/NO)?

Abdominal distension (YES/NO)?

Bacteremia (positive blood culture) (YES/NO)?

Gram positive bacteremia (YES/NO)?

Gram negative bacteremia (YES/NO)?

Specific bacteria identified - list name

Date/ day of illness when this was first isolated?

Sepsis (YES/NO)?

Septic Shock (YES/NO)?

Systemic Inflammatory Response Syndrome (YES/NO)?

Peripheral edema (YES/NO)?

Delirium (YES/NO)?

Encephalopathy (YES/NO)?

Seizure (YES/NO)?

Encephalitis (YES/NO)? [how diagnosed?]

Coma (YES/NO)?

Other infections diagnosed (malaria, typhoid, etc)? (Y/N)

What other infections? (please list)

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Sheet 7: 6 Interventions

Interventions during Hospitalization in Europe or the US

Patient number

Peripheral intravenous line (not PICC) (YES/NO)?

Peripherally inserted central catheter (PICC line) (YES/NO)?

Central venous cathether placement (YES/NO)?

Dialysis catheter insertion (YES/NO)?

Intravenous fluids

Normal saline (YES/NO)?

Maximum NS volume /24 hours

Lactated Ringers (YES/NO)?

Maximum LR volume /24 hours

Supplemental oxygen per nasal canula (YES/NO)?

Supplemental oxygen per face mask (YES/NO)?

External audio auscultation (YES/NO)?

Non-invasive ventilation (YES/NO)?

Number of days of Non-invasive ventilation

Invasive mechanical ventilation (YES/NO)?

Number of days of invasive mechanical ventilation

Continuous renal replacement therapy (CVVHD) (YES/NO)?

Number of days of CRRT

Vasopressor or Inotrope use (YES/NO)?

Number of days of vasopressor or inotrope use

Rectal tube placed (YES/NO)?

Foley tube placed (YES/NO)?

Resuscitation for cardiac arrest (YES/NO)?

If YES, chest compressions (YES/NO)?

If YES, epinephrine given (YES/NO)?

If YES, atropine given (YES/NO)?

If YES, bicarbonate given (YES/NO)?

If YES, transcutaneous pacing given (YES/NO)?

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Sheet 8: 7 Treatments

Treatments given during Hospitalization

Patient number

Anti-emetics (YES/NO)?

If YES, list anti-emetic 1

If YES, list anti-emetic 2

Loperamide (YES/NO)?

Anticonvulsants (YES/NO)?

If YES, list anticonvulsants

Anxiolytics (ES/NO)?

If YES, list anxiolytics

Whole blood transfusion (YES/NO)?

Fresh frozen plasma (YES/NO)?

Platelet transfusion (YES/NO)?

IVIG (YES/NO)?

Antibiotics (YES/NO)?

If YES, please list all antibiotics given

Antifungal (YES/NO)?

If yes, please list all antifungals given

Antivirals (other than for Ebola) (YES/NO)?

If yes, please list all antivirals given

Anti-malarials (YES/NO)?

If YES, list anti-malarial 1

If YES, list anti-malarial 2

Corticosteroids (YES/NO)?

Hydrocortisone (YES/NO)?

Methylprednisolone (YES/NO)?

Dexamethasone (Y/N)

Sedation (YES/NO)?

If YES, List sedative 1

If YES, List sedative 2

Analgesia (YES/NO)?

Aspirin (YES/NO)?

Acetominophen (YES/NO)?

Paracetomol (YES/NO)?

Ibubrofen (YES/NO)?

Other NSAID (YES/NO)?

Narcotics (YES/NO)?

Paralytics (YES/NO)?

If YES, list paralytic 1

If YES, list paralytic 2

Albumin (YES/NO)?

Potassium (YES/NO)?

If YES, was intravenous potassium given (YES/NO)?

If YES, was oral potassium given (YES/NO)?

Calcium (YES/NO)?

Magnesium (Yes/ No)?

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Sheet 9: 8 Investigational Therapies

Investigational therapies for EBOV infection

ZMAPP

ZMAB

TKM-Ebola

Favipiravir (T-705)

Brincidofovir (CMX-001)

Amiodarone

FX06

Convalescent plasma

Patient number

ZMapp (YES/NO)?

If YES, intravenous dosing given (e.g. 50mg/kg)?

If YES, total number of doses given?

If YES, dosing frequency?

If YES, started on what illness day?

If YES, any suspected adverse reaction (YES/NO)?

If adverse reaction, list all

ZMab (YES/NO)?

If YES, intravenous dosing given (e.g. 50mg/kg)?

If YES, total number of doses given?

If YES, dosing frequency?

If YES, started on what illness day?

If YES, any suspected adverse reaction (YES/NO)?

If adverse reaction, list all

TKM-Ebola (YES/NO)?

If YES, intravenous dosing given (0.3mg/kg)?

If YES, total number of doses given?

If YES, dosing frequency?

If YES, started on what illness day?

If YES, any suspected adverse reaction (YES/NO)?

If adverse reaction, list all

Favipiravir (T-705) (YES/NO)?

If YES, oral loading dose given?

If YES, oral maintenance dose given?

If YES, total number of doses given?

If YES, dosing frequency?

If YES, started on what illness day?

If YES, any suspected adverse reaction (YES/NO)?

If adverse reaction, list all

Brincidofovir (CMX-001) (YES/NO)?

If YES, oral loading dose given?

If YES, oral maintenance dose given?

If YES, total number of doses given?

If YES, dosing frequency?

If YES, started on what illness day?

If YES, any suspected adverse reaction (YES/NO)?

If adverse reaction, list all

Amiodarone (YES/NO)?

If YES, oral dosing given?

If YES, total number of doses given?

If YES, dosing frequency?

If YES, started on what illness day?

If YES, any suspected adverse reaction (YES/NO)?

If adverse reaction, list all

FX06 (YES/NO)?

If YES, intravenous dosing given)?

If YES, total number of doses given?

If YES, dosing frequency?

If YES, started on what illness day?

If YES, any suspected adverse reaction (YES/NO)?

If adverse reaction, list all

Convalescent plasma (YES/NO)?

If YES, volume of plasma given (ml or cc)

If YES, total number of transfusions given?

If YES, any suspected adverse reaction (YES/NO)?

If suspected reaction, was it TRALI (transfusion associated acute lung injury) (YES/NO)?

If suspected reaction, was it TACO (transfusion associated circulatory overload) (YES/NO)?

Other investigational therapeutic (YES/NO)?

If YES, Please list other therapeutic

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Sheet 10: 9 Admission Labs Final Hospital

Laboratory testing results on at Admission at Final Hospital

Patient number

Point of care laboratory testing used (YES/NO)?

If YES, iSTAT used (YES/NO)?

If YES, PICCOLO used (YES/NO)?

If YES, specify other test device

Sodium (mEq/liter)

Potassium (mEq/liter)

Chloride (mEq/liter)

Bicarbonate (mEq/liter)

Creatinine [mg/dL (US); umol/liter (Europe)]

BUN [mg/dL (US); mmol/liter (Europe]

Glucose [mg/dL (US); mmol/L (Europe)] off IV glucose

Calcium (mmol/L)

Ionized Calcium [mg/dL (US); mmol/L (Europe]

Magnesium (mEq/L)

AST (U/L)

ALT (U/L)

CK (U/L)

Lactate [mg/dL (US); mmol/L (Europe)]

Total bilirubin [mg/dL (US); mmol/L (Europe)]

Albumin (g/dL)

WBC (x 109/L)

Absolute lymphocyte count (x 109/L)

Abosoulte neutrophil count (x 109/L)

Platelets (x 109/L)

HgB (g/dL)

Hct (%)

Prothrobin time (seconds)

Partial throboplastin time (seconds)

INR

D-dimer (ng/ml)

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Sheet 11: 10 Labs Final Hospital

Laboratory testing results anytime during Final Hospitalization

Patient number

Sodium lowest value (mEq/liter)

Potassium lowest (mEq/liter)

Chloride lowest (mEq/liter)

Bicarbonate lowest (mEq/liter)

Creatinine highest [mg/dL (US); umol/liter (Europe)]

BUN highest [mg/dL (US); mmol/liter (Europe]

Glucose lowest [mg/dL (US); mmol/L (Europe)] off IV glucose

Glucose highest [mg/dL (US); mmol/L (Europe)] off IV glucose

Calcium lowest (mmol/L)

Ionized Calcium lowest [mg/dL (US); mmol/L (Europe]

Magnesium lowest (mEq/L)

AST highest (U/L)

Illness day (not hospital day) of peak AST associated with Ebola virus disease (not drug reaction)

ALT (U/L)

Illness day (not hospital day) of peak ALT associated with Ebola virus disease (not drug reaction)

CK highest (U/L)

Lactate highest [mg/dL (US); mmol/L (Europe)]

Total bilirubin highest [mg/dL (US); mmol/L (Europe)]

Albumin lowest (g/dL)

WBC lowest (x 109/L)

Illness day (not hospital day) of lowest WBC

WBC highest (x 109/L)

Illness day (not hospital day) of highest WBC

Absolute lymphocyte count lowest (x 109/L)

Abosoulte neutrophil count lowest (x 109/L)

Platelets lowest (x 109/L)

HgB lowest (g/dL)

Hct lowest (%)

Prothrobin time highest (seconds)

Partial throboplastin time highest (seconds)

INR highest

D-dimer highest (ng/ml)

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Sheet 12: 11 Virology& Immunology results

Virology and Immunology Testing Results During Entire Clinical Course until death or at discharge

testing on blood

URINE

OTHER CLINICAL SPECIMENS

Serology

patient number

Name of RT-PCR assay?

Where was RT-PCR assay performed (e.g. CDC, Ministry of Health laboratory, etc.)?

Initial Ct value in blood

Illness day of initial Ct result in blood

First available EBOV RNA level in blood (viral copies/ml)

Ilness day of first available EBOV RNA level in blood

Lowest Ct value

Illness day of lowest Ct value in blood

Highest blood EBOV RNA level (viral copies/ml)

Ilness day of highest blood EBOV RNA level

Illness day for 1st negative RT-PCR result in blood

Illness day for 2nd consecutive negative RT-PCR result in blood

Initial Ct value in urine

Illness day of initial Ct result in urine

First available EBOV RNA level in urine (viral copies/ml)

Ilness day of first available EBOV RNA level in urine

Was saliva tested (YES/NO)?

If YES, was saliva positive for EBOV by RT-PCR (YES/NO)?

If positive, when did saliva 1st become negative?

Was sweat tested (YES/NO)?

If YES, was sweat positive for EBOV by RT-PCR (YES/NO)?

If positive, when did swaet 1st become negative?

Was stool tested (YES/NO)?

If YES, was stool positive for EBOV by RT-PCR (YES/NO)?

If positive, when did stool 1st become negative?

Was a rectal swab tested (YES/NO)?

If YES, was a rectal swab positive for EBOV by RT-PCR (YES/NO)?

If positive, when did rectal swab 1st become negative?

Was a skin swab tested (YES/NO)?

If YES, was a skin swab positive for EBOV by RT-PCR (YES/NO)?

If positive, when did skin swab 1st become negative?

For female patients, was a vaginal swab tested (YES/NO)?

If YES, was a vaginal swab positive for EBOV by RT-PCR (YES/NO)?

If positive, when did vaginal swab 1st become negative?

For male patients, was a semen specimen collected in the hospital (YES/NO)?

If YES, was a semen specimen swab positive for EBOV by RT-PCR (YES/NO)?

If positive, when did semen 1st become negative? (or how long documented positive)

Was EBOV serological testing performed (YES/NO)?

If YES, first illness day that EBOV IgM titer was detected?

If YES, first illness day that EBOV IgG titer was detected?

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Sheet 13: 12 Outomes

Outcomes

For survivors

Discharge criteria used

Condition at Dicharge

Disposition

Patient number

Alive at 14 days after illness onset (YES/NO)?

Alive at 28 days after illness onset (YES/NO)?

Died (YES/NO)?

For fatal cases, time (days) from illness onset to death

Duration of Final Hospital Admission to documented clearance of EBOV viremia (total number of days in Final Hospital to 2nd consecutive negative RT-PCR result in blood)

Duration of days Final Hospital Admission (total number of in Final Hospital to discharge or death)

Required supplemental oxygen at discharge (YES/NO)?

Required diaylsis at discharge (YES/NO)?

Clearance of EBOV viremia by one negative RT-PCR result in blood (YES/NO)?

Clearance of EBOV viremia by two consecutive negative RT-PCR results in blood (YES/NO)?

EBOV RNA not detected by RT-PCR in blood and urine (YES/NO)?

EBOV RNA not detected by RT-PCR in any clinical specimens (YES/NO)?

Weakness (YES/NO)?

Weight loss (YES/NO)?

Anemia (YES/NO)?

Fatigue (YES/NO)?

Any lab abnormalities (YES/NO)?

If YES, what labs remained abnormal?

Home (YES/NO)?

Rehabilitation center (YES/NO)?