Documentation Changelog

The eCRF is mod­i­fied in cooper­a­tion with you as doc­u­ment­ing LEOSS’ians, med­ic­al soci­et­ies, and part­ners accord­ing to their expert­ise and updated inform­a­tion. We do not expect any sub­sequent doc­u­ment­a­tion of already com­pleted cases! Already entered data in the pre­vi­ous ques­tion formats has of course been stored.

Do you want to get involved? Do you have any feed­back or sug­ges­tions? Do you have any ques­tions? Or do you just want to keep your­self updated? Con­tact us by mail or join our chat platform!

Change Log

📖 = new sub ques­tion­naire has been added
💥 = new ques­tion has been added
➕ = new answers have been added
🔁 = ques­tion has been updated

2021-06-15

Baseline I

•  ➕ Treat­ments received
  • • + Obesity

Baseline II

• 💥 4C Mor­tal­ity Score: Age
• 💥 4C Mor­tal­ity Score: Res­pir­at­ory rate at admission
• 💥 4C Mor­tal­ity Score: Peri­pher­al oxy­gen sat­ur­a­tion on room air at admission
• 💥 4C Mor­tal­ity Score: Glas­gow Coma Scale at admission
• 💥 4C Mor­tal­ity Score: Blood urea at admission
• 💥 4C Mor­tal­ity Score: CRP at admission

2021-05-28

Baseline I

• 🔁 Vac­cine used for COVID-19?

2021-03-19

Baseline I

• 💥 Vac­cine used for COVID-19?

Neurology

• 🔁 Neur­o­lo­gic­al status pri­or to cur­rent ill­ness: Swallowing

2021-03-12

Neurology

• 🔁 Medic­a­tion in cerebrovas­cu­lar dis­ease: War­far­in /​ mar­cu­mar 

2021-02-12

Baseline I

• 💥 Sequen­cing: Vari­ant of con­cern (VOC)

2021-01-26

Baseline I

• 💥 Vac­cin­ated for COVID-19?
• 💥 Con­text of diagnosis

Uncomplicated phase

•  ➕ Treat­ments received
  • • + Mono­clonal anti­body ther­apy (e.g. Bam­lanivimab, REGN-COV‑2)

Complicated phase

•  ➕ Treat­ments received
  • • + Mono­clonal anti­body ther­apy (e.g. Bam­lanivimab, REGN-COV‑2)

Critical phase

•  ➕ Treat­ments received
  • • + Mono­clonal anti­body ther­apy (e.g. Bam­lanivimab, REGN-COV‑2)

2020-12-21

Baseline I

• 🔁 Month of first diagnosis
• 💥 Can the cur­rent SARS-CoV­‑2 infec­tion be con­sidered as a re-infection?
• 💥 Employ­ment in the health care sector
  
• 💥 Lung ultra­sound
• ➕ Symp­toms
  • • + Swollen lymph nodes
      
    • + Skin rash

Uncomplicated phase

•  💥 Lung ultra­sound
•  💥 Dur­a­tion of fever
• ➕ Treat­ments received
  
  • • + Myco­lyt­ic agents
      
    • + Non­s­ter­oid­al anti-inflam­mat­ory drugs (e.g. aspir­in, ibupro­fen, coxibs)
    • + Paracetamol
    • + Metamizole

Complicated phase

•  💥 Lung ultra­sound
•  💥 Dur­a­tion of fever
• ➕ Treat­ments received
  
  • • + Myco­lyt­ic agents
      
    • + Non­s­ter­oid­al anti-inflam­mat­ory drugs (e.g. aspir­in, ibupro­fen, coxibs)
    • + Paracetamol
    • + Metamizole

Critical phase

•  💥 Lung ultra­sound
•  💥 Dur­a­tion of fever
• ➕ Treat­ments received
  
  • • + Myco­lyt­ic agents
      
    • + Non­s­ter­oid­al anti-inflam­mat­ory drugs (e.g. aspir­in, ibupro­fen, coxibs)
    • + Paracetamol
    • + Metamizole

Recovery phase

•  💥 Lung ultra­sound

Immunosuppressive drug related data

• 🔁 Check­point inhib­it­or ther­apy (last 3 months)

Diabetes mellitus related data

• 🔁 Hemo­globin A1c (HbA1c ) in blood
  
• 🔁 C‑peptide in blood
• 🔁 Insulin in blood
• 🔁 Cortisol in blood

Apheresis therapy related data

• ➕ Type of apher­es­is therapy
  • • + CRP apheresis
      

Cardiovascular related data

• 🔁 Stage of heart fail­ure at dia­gnos­is (NYHA classification)
  
• 🔁 Pri­or heart fail­ure at diagnosis

2020-11-10

Baseline I

• 🔁 Dur­a­tion (days) of…

2020-07-23

Baseline I

• 🔁 Vital signs and res­pir­at­ory parameters 

Uncomplicated phase

• 🔁 Vital signs and res­pir­at­ory parameters 

Complicated phase

• 🔁 Vital signs and res­pir­at­ory parameters 

Critical phase

• 🔁 Vital signs and res­pir­at­ory parameters 

Recovery phase

• 💥 Vital signs and res­pir­at­ory parameters

2020-07-13

Baseline I

• 💥 Com­plic­a­tions at baseline
• ➕ Comor­bid­it­ies
  • • + Oth­er car­di­ovas­cu­lar disease
    • + Oth­er hem­at­o­lo­gic­al disease
    • + Pol­len sensitization
    • + Dust mite sensitization 
    • + Oth­er sensitization
    • + Trau­mat­ic injury (e.g. head, chest, abdom­in­al and skelet­al injuries)
    • + Burn
    • + Alco­hol abuse 

Baseline II

• ➕ 5x Hem­at­o­lo­gic­al Values
  • • + Eos­ino­phils

2020-07-08

Baseline I

• 💥 Was lim­it­a­tion of ther­apy dis­cussed at any time dur­ing the SARS-CoV­‑2 infection?
• 💥 Did the patient receive spe­cial­ist pal­li­at­ive care dur­ing the SARS-CoV­‑2 infection?
• 💥 Did the patient suf­fer from a life lim­it­ing dis­ease with a pro­gnos­is of less than one year to live before first pos­it­ive test­ing of SARS-CoV­‑2?
• 🔁 Known col­on­iz­a­tion with multi-res­ist­ant pathogens

Ethics and palliative care

• 📖 Eth­ics and pal­li­at­ive care 📖

2020-06-30

Emergency care

• ➕ Oxy­gen inhalation
  • • + No oxy­gen inhalation

2020-06-22

HIV

• 💥 Please indic­ate the CDC stage

2020-06-19

HIV

• 🔁 HIV trans­mis­sion risk
• ➕ Does the patient receive cur­rent anti­ret­ro­vir­al therapy?
  • • + Entry inhib­it­ors (e.g. Mara­viroc, Enfuvirtide)
• 💥 In case of anti­ret­ro­vir­al ther­apy for how long has anti­ret­ro­vir­al ther­apy been taken before first pos­it­ive SARS-CoV­‑2 testing?
• 💥 Has anti­ret­ro­vir­al ther­apy been changed /​ been star­ted dur­ing the course of SARS-CoV­‑2 infection?
• 💥 Please indic­ate the regi­men at the end of the fol­low-up periode.
• 🔁 CD4+ T‑cell count (abs.)
• 🔁 CD4+ T‑cell count (rel.)
• 💥 CD8+ T‑cell count (abs.)
• 💥 CD8+ T‑cell count (rel.)
• 🔁 Vir­al load
• 💥 Did any oppor­tun­ist­ic infec­tions, AIDS-defin­ing ill­nesses or STI (sexu­ally trans­mit­ted infec­tion) occur dur­ing SARS-CoV­‑2 infection? 

Uncomplicated phase

• ➕ Anti­bac­teri­al treatment
  • • + Penicillins/​aminopenicillins
    • + Ceph­alospor­ins I‑III
      

Complicated phase

• ➕ Anti­bac­teri­al treatment
  • • + Penicillins/​aminopenicillins
    • + Ceph­alospor­ins I‑III
      

Critical phase

• ➕ Anti­bac­teri­al treatment
  • • + Penicillins/​aminopenicillins
    • + Ceph­alospor­ins I‑III
      

Recovery phase

• ➕ Anti­bac­teri­al treatment
  • • + Penicillins/​aminopenicillins
    • + Ceph­alospor­ins I‑III
      

2020-06-16

Baseline I

• ➕ How did the patient come to the health care facility?
  • • + By air-bound transport
    • + By intra-hos­pit­al patient transfer
    • + By intens­ive care transport
• ➕ Where did the patient stay before SARS-CoV­‑2 detection?
  • • + Rehab­il­it­a­tion facility
    • + Refugee accomodation
• ➕ Where did the patient stay after the fol­low-up period?
  • • + Rehab­il­it­a­tion facility
    • + Refugee accomodation
    • + Patient died

Complicated phase

• ➕ Complications 
  • • + Gastrointest­in­al bleeding

Critical phase

• ➕ Com­plic­a­tions 
  • • + Endo­tracheal bleed­ing
    • + Gastrointest­in­al bleeding

Recovery phase

• ➕ Not recovered symptoms
  • • + Cough
    • + Muscle aches 
    • + Head­ache
    • + Mild fatigue 

Pulmonary diseases

• ➕ Oth­er chron­ic pul­mon­ary dis­ease, please specify
  • • + Sarc­oidos­is
    • + Chron­ic bronchitis
    • + Emphysema

2020-06-15

Baseline II

• 🔁 PCR: Site of first detec­ted SARS-CoV­‑2 
• 🔁 Urine test strips
• 🔁 4x PCR: Sites of vir­o­lo­gic­al testing

Oncology

• 💥 Check­point inhib­it­or ther­apy (last 3 months)

2020-06-09

Baseline II

• 🔁 4x Labor­at­ory values
• 💥 Labor­at­ory val­ues 
• 💥 Hem­at­o­lo­gic­al val­ues 
• 💥 CRP (highest) 
• 💥 Pro­c­al­citon­in (PCT) (highest)
• 💥 Inter­leuk­in 6 (highest)
• 💥 sIL2R (highest)
• 💥 Fer­ritin (highest)
• 💥 INR (highest)
• 💥 Activ­ated par­tial throm­boplastin time (aPTT) (highest)
• 💥 5x Anti­th­rom­bin III activ­ity (low­est)
• 💥 2x NT-pro-BNP

Uncomplicated phase

• 💥 Anti­bac­teri­al treat­ment  

Complicated phase

• 💥 Anti­bac­teri­al treat­ment 

Critical phase

• 💥 Anti­bac­teri­al treatment

Recovery phase

• 💥 Anti­bac­teri­al treat­ment 

2020-06-06

Neurology

• 💥 If neur­o­lo­gic­al ima­ging (cCT, cMRI) was per­formed, plese specify 
  
• 💥 If an EEG was per­formed, please specify
• 💥 If elec­tro­physiology was per­formed, please specify
• 💥 If a spin­al tap was per­formed, please specify 
  
• 💥 Cerebrospin­al flu­id: patho­gen and anti­body test­ing Status 
• 🔁 Cog­nit­ive /​ neuro­psy­chi­at­ric impairment
• 🔁 Vis­ion impairment
• 🔁 Ocu­lo­mo­tor impairment
• 🔁 Pares­is
• 🔁 Abnor­mal muscle reflexes
• 🔁 Sens­ory deficit
• 🔁 Fur­ther symp­toms and findings
• 🔁 Any oth­er symptom

2020-06-02

Emergency care

• 💥 How did the patient come to the emer­gency care facility?

Complementary and integrative medicine (CIM) 

• 💥 Were these food sup­ple­ments used? 

2020-05-27

Baseline II

• ➕ 3x Vir­al coinfection(s)
  • • + HSV (Herpes sim­plex virus)
• 🔁 5x If Anti-SARS-CoV­‑2 anti­bod­ies (IgG) were meas­ured: highest titer.
• 🔁 5x If Anti-SARS-CoV­‑2 anti­bod­ies (IgA) were meas­ured: highest titer.

Uncomplicated phase

• ➕ Treat­ments received
  • • + Mara­viroc
    • + IL-6-recept­or ant­ag­on­ist (Tocil­i­zu­mab)
    • + IL-1-recept­or antagonists
    • + Immun­o­globu­lines
    • + Apher­es­is therapy
• 🔁 Oth­er COVID-19 related drug therapy

Complicated phase

• ➕ Treat­ments received
  • • + Maraviroc
    • + Ilo­prost
    • + Nitrates (nitrogly­cer­in, ISMN, Molsidom­in, NO)
    • + Avi­ptadil (VIP analog)
• 🔁 Oth­er COVID-19 related drug therapy

Critical phase

• ➕ Treat­ments received
  • • + Mara­viroc
    • + Ilo­prost
    • + Nitrates (nitrogly­cer­in, ISMN, Molsidom­in, NO)
    • + Avi­ptadil (VIP analog)
• 🔁 Oth­er COVID-19 related drug therapy
• 💥 Acute kid­ney injury (KDIGO criteria)
  •  

2020-05-23

Baseline I

• 💥 Where did the patient stay after the fol­low-up period?
• 💥 Did the patient par­ti­cip­ate in an inter­ven­tion­al clin­ic­al trial?
• ➕ Dur­a­tion (days) of…
  • • + Inter­me­di­ate care unit (IMCU) stay
    • + ECMO support

2020-05-22

Oncology

• 💥 Stem cell transplantation

2020-05-20

HIV

• ➕ HIV: Does the patient receive cur­rent anti­ret­ro­vir­al therapy?
  • • + Nuc­le­os­ide ana­log reverse-tran­scriptase inhib­it­ors 

2020-05-15

Critical phase

• ➕ ICU treat­ment
  • • + High flow oxy­gen supplementation
    • + Low flow oxy­gen supplementation
    • + Tracheotomy

2020-05-13

Baseline I

• 💥 Has a car­di­ovas­cu­lar mag­net­ic res­on­ance ima­ging (CMR) been per­formed in any clin­ic­al phase ?

CMR

• 📖 Car­di­ovas­cu­lar mag­net­ic res­on­ance ima­ging (CMR) 📖

2020-05-12

Baseline II

• 🔁 3x Vir­al coinfection(s)
• ➕ Throm­bos­is pro­phy­lax­is /​ anti­co­agu­la­tion /​ plate­let aggreg­a­tion inhibition
  • • + Hep­ar­in, sub­thera­peut­ic dose (but high­er than pro­phy­lact­ic dose)
    • + Low molecu­lar weight hep­ar­in, sub­thera­peut­ic dose (but high­er than pro­phy­lact­ic dose)
    • + Argatroban
    • + Aspir­in
    • + ADP recept­or inhib­it­ors (Clop­ido­grel, Can­grelor, Ticagrelor)
    • + Gly­copro­tein IIB/​IIIA inhibitors

Uncomplicated phase

• ➕ Throm­bos­is pro­phy­lax­is /​ anti­co­agu­la­tion /​ plate­let aggreg­a­tion inhibition
  • • + Hep­ar­in, sub­thera­peut­ic dose (but high­er than pro­phy­lact­ic dose)
    • + Low molecu­lar weight hep­ar­in, sub­thera­peut­ic dose (but high­er than pro­phy­lact­ic dose)
    • + Argatroban
    • + Aspir­in
    • + ADP recept­or inhib­it­ors (Clop­ido­grel, Can­grelor, Ticagrelor)
    • + Gly­copro­tein IIB/​IIIA inhibitors

Complicated phase

• ➕ Throm­bos­is pro­phy­lax­is /​ anti­co­agu­la­tion /​ plate­let aggreg­a­tion inhibition
  • • + Hep­ar­in, sub­thera­peut­ic dose (but high­er than pro­phy­lact­ic dose)
    • + Low molecu­lar weight hep­ar­in, sub­thera­peut­ic dose (but high­er than pro­phy­lact­ic dose)
    • + Argatroban
    • + Aspir­in
    • + ADP recept­or inhib­it­ors (Clop­ido­grel, Can­grelor, Ticagrelor)
    • + Gly­copro­tein IIB/​IIIA inhibitors

Critical phase

• ➕ Throm­bos­is pro­phy­lax­is /​ anti­co­agu­la­tion /​ plate­let aggreg­a­tion inhibition
  • • + Hep­ar­in, sub­thera­peut­ic dose (but high­er than pro­phy­lact­ic dose)
    • + Low molecu­lar weight hep­ar­in, sub­thera­peut­ic dose (but high­er than pro­phy­lact­ic dose)
    • + Argatroban
    • + Aspir­in
    • + ADP recept­or inhib­it­ors (Clop­ido­grel, Can­grelor, Ticagrelor)
    • + Gly­copro­tein IIB/​IIIA inhibitors

2020-05-11

Baseline I

• 💥Where did the patient stay before SARS-CoV­‑2 detection?
• 💥 How did the patient come to your facility?
• ➕ Chest CT results 
  • • + Chest x‑ray res­ults, please spe­cify (short descrip­tion: no copy & paste)

Uncomplicated phase

• ➕ Chest CT results 
  • • + Chest x‑ray res­ults, please specify (short descrip­tion: no copy & paste)

Complicated phase

• ➕ Chest CT results 
  • • + Chest x‑ray res­ults, please spe­cify (short descrip­tion: no copy & paste)

Critical phase

• ➕ Chest CT results 
  • • + Chest x‑ray res­ults, please spe­cify (short descrip­tion: no copy & paste)

Recovery phase:

• ➕ Chest CT results 
  • • + Chest x‑ray res­ults, please spe­cify (short descrip­tion: no copy & paste)

Diabetes

• 💥 Has insulin treat­ment been used before SARS-CoV­‑2 detection?
• 💥 Has the insulin scheme been changed at the time of SARS-CoV­‑2 detec­tion (+/- 48 h)?
• 💥 Which oral anti­dia­bet­ic treat­ment has been used before SARS-CoV­‑2 detection?

2020-05-09

Complicated phase

• 🔁 Com­plic­a­tions

Critical phase

• 🔁 Com­plic­a­tions

2020-05-08

Baseline I

• ➕ Treat­ments received
  • • + Vit­am­in D

Complicated phase

• ➕ Symp­toms /​ find­ings of com­plic­ated phase
  • • + Need for new oxy­gen sup­ple­ment­a­tion (based on clin­ic­al impres­sion or test results)
    • + Clin­ic­ally meaning­ful increase of pri­or oxy­gen home therapy

Critical phase

• ➕ Symp­toms /​ find­ings of crit­ic­al phase
  • • + Need for unplanned mech­an­ic­al ventilation
    • + Pro­longation (> 24 h) of planned mech­an­ic­al ventilation

Oncology

• 💥 Dia­gnos­is date of hem­at­o­lo­gic­al /​ onco­lo­gic­al disease

Immunosuppressive drugs

• ➕ Anti­bod­ies
  • • + Other, please specify
• ➕ Chemo­thera­peut­ics
  • • + Oth­er, please specify
• ➕ Inhib­it­ors
  • • + Other, please specify
• ➕ Oth­er immun­sup­press­ive regimens
  • • + > 100 mg /​ d pred­niso­lone equivalent
    • + Oth­er, please specify

2020-05-07

Baseline II

• 💥 4x Activ­ated par­tial throm­boplastin time (aPTT)
• 💥 4x INR

2020-05-06

Baseline II

• ➕ 5x PCR: Sites of vir­o­lo­gic­al testing
  • • + Earlobe capil­lary blood
• 💥 TSH
• 💥 CK (Cre­at­ine kinase)
• 💥 5x CK‑MB in ref­er­ence to above indic­ated CK

2020-05-05

Oncology

• 💥 Please spe­cify the under­ly­ing NHL
• 🔁 Under­ly­ing disease
• ➕ Status at detec­tion of SARS-CoV­‑2
  • • + Remission