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.

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Change Log

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


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

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