US/WHO Clinical Network EVD Data Collection Tool

Data Supplement for Ebola Virus Disease Patients Treated Outside of West Africa

AppndxC US-WHO ClinNetworkEVDDataCollTool 20150604.xlsx

US/WHO International Clinical Network Ebola Virus Disease Clinical Data Collection Tool

OMB: 0920-1069

Document [xlsx]
Download: xlsx | pdf

Overview

US-WHO Clinical Network Cover
1 Demographics and Background
2a Signs & Symptoms at ONSET
2b 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
11A Virology Immunology results
11B Virology Results
12 Outomes


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.













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 For Females, Pregnant (YES/NO); if YES, what trimester 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) For Medically evacuated patients, were IV fluids given in West Africa before medical evacuation (YES/NO)? 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)?

Sheet 3: 2a Signs & Symptoms at ONSET

Signs and Symptoms on First Day of Illness = DAY of ILLNESS ONSET















Feverishness (temperature not measured (YES/NO)? Fever (measured elevated temperature) (YES/NO)? Headache (YES/NO)? Weakness (YES/NO)? Fatigue or increased tiredness (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)?

Sheet 4: 2b 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 was temperature 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)

Sheet 5: 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 (YES/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)?

Sheet 6: 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)?

Sheet 7: 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)

Sheet 8: 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)?

Sheet 9: 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 Was IV Albumin given (YES/NO)? If Albumin was given, what was the highest amount (volume) given in a 24-hour period (25% Albumin or specifcy), and specify volume given Was Potassium given (YES/NO)? If YES, was intravenous potassium given (YES/NO)? If YES, what was the total amount of IV potassium given in mEq during hospitalization in the US or Europe? If YES, was oral potassium given (YES/NO)? If YES, what was the total amount of oral potassium given in mEq during hospitalization in the US or Europe? Calcium (YES/NO)? If YES, what was the total amount of IV calcium given in mEq during hospitalization in the US or Europe? If YES, what was the total amount of oral calcium given in mEq during hospitalization in the US or Europe? Was Magnesium given (Yes/ No)? If YES, what was the total amount of IV Magnesium given in mEq during hospitalization in the US or Europe? If YES, what was the total amount of oral Magnesium given in mEq during hospitalization in the US or Europe? Was treatment given for a prothrombotic state (YES/NO)? If Treated for Prothrombotic state, what treatment was given (e.g. low molecular wt heparin, aspirin, etc.; but not for DVT prophylaxis)?

Sheet 10: 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

Sheet 11: 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) CRP (mg/L) ESR (mm/hr)

Sheet 12: 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) Platelets highest (x 109/L) Illness day of highest platelet count? Thrombocytosis (platelets ever >450,000) (YES/NO)? HgB lowest (g/dL) Hct lowest (%) Prothrobin time highest (seconds) Partial throboplastin time highest (seconds) INR highest D-dimer highest (ng/ml)

Sheet 13: 11A 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?

Sheet 14: 11B Virology Results

Virology Testing Results on Blood Specimens During Entire Clinical Course until death or at discharge

















































patient number First available Ct value in blood (and day of illness in parentheses) First available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Second available Ct value in blood (and day of illness in parentheses) Second available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Third available Ct value in blood (and day of illness in parentheses) Third available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Fourth available Ct value in blood (and day of illness in parentheses) Fourth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Fifth available Ct value in blood (and day of illness in parentheses) Fifth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Sixth available Ct value in blood (and day of illness in parentheses) Sixth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Seventh available Ct value in blood (and day of illness in parentheses) Seventh available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Eighth available Ct value in blood (and day of illness in parentheses) Eighth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Ninth available Ct value in blood (and day of illness in parentheses) Ninth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Tenth available Ct value in blood (and day of illness in parentheses) Tenth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Eleventh available Ct value in blood (and day of illness in parentheses) Eleventh available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Twelfth available Ct value in blood (and day of illness in parentheses) Twelfth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Thirteenth available Ct value in blood (and day of illness in parentheses) Thirteenth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Fourteenth available Ct value in blood (and day of illness in parentheses) Fourteenth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Fifteenth available Ct value in blood (and day of illness in parentheses) Fifteenth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Sixteenth available Ct value in blood (and day of illness in parentheses) Sixteenth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Seventeenth available Ct value in blood (and day of illness in parentheses) Seventeenth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Eighteenth available Ct value in blood (and day of illness in parentheses) Eighteenth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Nineteenth available Ct value in blood (and day of illness in parentheses) Nineteenth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Twentieth available Ct value in blood (and day of illness in parentheses) Twentieth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Twenty-first available Ct value in blood (and day of illness in parentheses) Twenty-first available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Twenty-second available Ct value in blood (and day of illness in parentheses) Twenty-second available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Twenty-third available Ct value in blood (and day of illness in parentheses) Twenty-third available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Twenty-fourth available Ct value in blood (and day of illness in parentheses) Twenty-fourth available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses) Twenty-five available Ct value in blood (and day of illness in parentheses) Twenty-five available EBOV RNA level in blood [viral copies/ml] (and day of illness in parentheses)

Sheet 15: 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)?
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