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


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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