case report form - icnarc
TRANSCRIPT
UK REMAP‐CAP Case Report Form V8, dated 20210226 Page 1 of 1 www.remapcap.org
CASE REPORT FORM
Participant Study Number
Date & Time Randomised D D M M M Y Y Y Y H : M MH
e.g. 01/JUN/2018 e.g. 8:05pm = 20:05 hours
24 hour clock
Case Report Forms to be completed
Form 3: Microbiology
Form 2: Baseline
Form 6: Discharge
Form 7: Consent
Allocated to A
V8
Form 5: Medication Administration
C
M
I
Form 12: Serious Adverse Event (if applicable)
Form 10: Day 180 (if applicable)
Form 11: Adverse Event (if applicable)
Form 13: Protocol Deviation (if applicable)
Form 9: Day 90 (if applicable)
X Y
P H
L S
B R
Form 8: Day 21 (if applicable)
Form 4: Daily
UK REMAP‐CAP Case Report Form 2, V8 dated 20210226 Page 1 of 4 www.remapcap.org
PLATFORM
Hospital admission source:
Assisted living not in own home
Home / community
Nursing home / chronic care / palliative care
(check one)
4.0 PAST MEDICAL HISTORY
NYChronic respiratory or pharyngeal neuromuscular weakness: Yes No
Diabetes: Not diagnosed with diabetes
Type 1 diabetes
Current gestational diabetes
Type 2 diabetes
Chronic kidney disease:Normal renal function
Abnormal renal function not normally receiving dialysis
Not recorded
Normally receiving dialysis
Participant Study Number
Baseline Patient Initials
(check one)
(check one)
1.0 HOSPITAL & ICU ADMISSION SOURCE
Complete Protocol Deviation CRF
(This hospital admission)
(Prior to this acute illness onset)
Hospital admission date & time: D D M M M Y Y Y Y H
e.g. 01/JUN/2018 e.g. 8:05pm = 20:05hours
: M MH 24 hour clock,
Postpartum at hospital admission:
Height:
2.0 DEMOGRAPHICS
cm inches
kg lbsWeight:
Pregnant at hospital admission:
Gestation in weeks: weeks
3.0 ENVIRONMENTAL RISK FACTORS
History of hazardous alcohol consumption:
Yes NY No N Not recordedCurrent tobacco smoker:
Yes NY No N Not recorded
feet
IF YES
IF NO
Yes NY No
Yes NY No N Not applicable
Skip to section 3
(At or before randomisation)
(Prior to this acute illness onset)
Yes NY No
ICU admission source: Emergency department – same hospital
ICU/HDU – same hospital
Emergency department – other hospital
ICU/HDU – other hospital
Ward – other hospitalWard – same hospital
(check one)
Patient location at baseline: Physical ICU Ward
EDRe‐purposed ICU
If in the Ward or ED, go to section 2(check one)
Patient is a healthcare worker:
UK REMAP‐CAP Case Report Form 2, V8 dated 20210226 Page 2 of 4 www.remapcap.org
NY Yes No
Other APACHE II co‐morbidities:
Respiratory co‐morbidities: Asthma(check all that apply)
Severe respiratory co‐morbidity:
Immunosuppressive treatment: Yes NY No
1
5.0 APACHE II
APACHE II acute physiology score:
Other
Immunosuppressive disease:
Chronic cardiovascular disease
Cirrhosis
Other
(check one)Clinical frailty score:
Well
Very fit
Managing well
2
3 6
7
8
9
Severely frail
Moderately frail
Very severely frail
Terminally ill
(0‐60) APS
If a respiratory co‐morbidity was selected (excluding NONE),answer the next question
(check all that apply)AIDS
Acute leukaemia
Lymphoma
Myeloma
None
6.0 INTERVENTIONS & PHYSIOLOGY AT BASELINE
Participant Study Number
Baseline Patient Initials
Bronchiectasis
Interstitial lung disease
Chronic obstructive pulmonary disease
Primary lung cancer
Hepatic failure
None of the above
Metastatic cancer
None
(check all that apply)
IF A RESPIRATORY CO‐MORBIDITY
Vulnerable4
5 Mildly frail
(This hospital admission, closest
prior to randomisation)
(24 hours prior to randomisation)
Creatinine: µmol/L mg/dL.
Platelet count: Cells x 109 /L
N Not recorded
N Not recorded
Bilirubin: N Not recorded
Lactate: mmol/L.
FiO2 at time of ABG: e.g. room air = 0.21.
N Not recorded
Corresponding PaO2: mmHg kPa.
Corresponding PEEP: cmH2O.
N Not recorded
N Not recorded
Glasgow Coma Scale Score:
µmol/L mg/dL.
mg/dL
Cells/mm3
N Not recorded
P Patient receiving APRV
COVID‐19 vaccination prior to this acute illness:
NY Yes No U Unknown(check one)
UK REMAP‐CAP Case Report Form 2, V8 dated 20210226 Page 3 of 4 www.remapcap.org
Participant Study Number
Baseline Patient Initials
Renal replacement therapy: Yes NY No
Yes NY NoExtracorporeal gas exchange:
Received: Extracorporeal membrane oxygenation (ECMO)
Extracorporeal carbon dioxide removal (ECCO2R)(check all that apply)
Skip to section 7 (if applicable)
IF YES
Extended Cardiovascular SOFA score:(check one)
0 1 2 3 4 4+
Yes NY NoTreatment limitation: Only collect for patients enrolled in the moderate state (not receiving organ support at the time of randomisation)
7.0 PHYSIOLOGY AT BASELINE (PANDEMIC ONLY) (Closest prior to randomisation, within 8 hours of randomisation or two hours after randomisation)
Ferritin: N Not recorded
D‐dimer:
C‐Reactive Protein:
Neutrophil count:
Lymphocyte count: Cells x 109 /L.
Cells x 109 /L.
µg/L or ng/mL
N Not recorded
N Not recorded
N Not recorded
N Not recorded
µg/L or ng/mL µg/mL or mg/L.
Cells/mm3
Cells/mm3
INR or Prothrombin ratio (PR): N Not recorded
Fibrinogen: g/L N Not recorded
.
mg/dL
(INR: preferred; PR: accepted)
.
Temperature: N Not recorded
Heart rate:
Systolic blood pressure:
Respiratory rate:
Bicarbonate: mEq/L.
mmHg
N Not recorded
N Not recorded
N Not recorded
N Not recorded
oC.
bpm
Albumin: g/dL. N Not recorded
8.0 CORTICOSTEROID DOMAIN
Was etomidate administered between hospital admission and randomisation: Yes NY No
mg/L or µg/mL mg/dL..
bpm
ALT:
AST:
Potassium:
IU/L
IU/L
mEq/L or mmol/L.
N Not recorded
N Not recorded
N Not recorded
Troponin:
ng/L or pg/mL N Not recordedng/mL
Test
(check one)
High sensitivity Troponin T Troponin T
Troponin I
Result .
N Not recorded
ng/mL.ng/L or pg/mLUpper reference limit (99th percentile)
High sensitivity Troponin I
oF.
mmol/L.
UK REMAP‐CAP Case Report Form 2, V8 dated 20210226 Page 4 of 4 www.remapcap.org
Participant Study Number
Baseline Patient Initials
PLATFORM PATIENT SUMMARY PAGE (United Kingdom sites only,
not a part of the Baseline eCRF)
END OF BASELINE CRF
ICNARC Case Mix Programme Admission Number:
UNITED KINGDOM SITES ONLY (on Spiral database)
UK REMAP‐CAP Case Report Form 3, V8 dated 20210226 Page 1 of 4 www.remapcap.org
Upper or lower respiratory tract PCR test result:
1.0 CAUSATIVE ORGANISM
On specimens collected within 72 hours of hospital admission
Influenza A
Influenza B
Legionella spp
+ Positive result ‐ Negative result
+ Positive result ‐ Negative result
+ Positive result ‐ Negative result
On specimens collected within 72 hours of hospital admission (check all that apply)
Chlamydophila pneumoniae
Mycoplasma pneumoniae
Respiratory Syncytial Virus
Coronavirus
Participant Study Number
Microbiology Patient Initials
N Not tested
N Not tested
N Not tested
Other upper or lower respiratory tract PCR detected organisms:
Not tested / None of the above positive
Urinary antigen test performed:
Which organisms were detected:
Y Yes N No
Skip to aspergillus question
On specimens collected at any time during this hospital admission
(check all that apply)
Legionella pneumophila serogroup 1
Streptococcus pneumoniae
None of the above
PLATFORM
IF YES
Tuberculosis detected on PCR or culture: Y Yes N NoOn specimens collected at any time during this hospital admission
(On specimens collected within the first 72 hours of this hospital admission, unless otherwise indicated)
Aspergillus isolated from the lower respiratory tract
On specimens collected at any time during this hospital admission
Invasive pulmonary aspergillosis diagnosed and treated with one or more systemic antifungal agentsDiagnosed by the treating clinician at any time during hospital admission
Y Yes N No
Y Yes N No
SARS‐CoV‐2 + Positive result ‐ Negative result N Not tested
On specimens collected during this acute respiratory illness, up until 72 hours after completion of the eligibility assessment
UK REMAP‐CAP Case Report Form 3, V8 dated 20210226 Page 2 of 4 www.remapcap.org
2.0 POSITIVE BLOOD CULTURE
Which organisms were detected:
Participant Study Number
Microbiology Patient Initials
(check all that apply)
Acinetobacter spp
Escherichia coli
Haemophilus influenzae
Burkholderia pseudomallei
Klebsiella spp
Pseudomonas aeruginosa
Staphylococcus aureus
Moraxella catarrhalis
Streptococcus pneumoniae
Streptococcus pyogenes
Coagulase negative staphylococci
Corynebacterium, Bacillus spp, Micrococcus, Propionibacterium
Other, specify
Streptococcus agalactiae
Yes NY No
YesY N No
Reported as resistant to ceftazidime and/or piperacillin‐tazobactam:
Reported as resistant to meropenem and/or imipenem:
PLATFORM
IF ACINETOBACTER SPP
(On specimens collected within the first 72 hours of this hospital admission, unless otherwise indicated)
Reported as resistant to ceftazidime and/or piperacillin‐tazobactam:
Reported as resistant to meropenem and/or imipenem:
Reported as methicillin‐resistant staphylococcus aureus:
Reported as resistant to erythromycin and/or azithromycin:
Reported as resistant to penicillin:
IF PSEUDOMONAS AERUGINOSA
Reported as resistant to moxifloxacin, norfloxacin and/or levofloxacin:
Reported as resistant to ceftriaxone and/or ceftazidime:
Reported as resistant to meropenem and/or imipenem:
Reported as resistant to ceftriaxone and/or ceftazidime:
Reported as resistant to meropenem and/or imipenem:
IF STAPHYLOCOCCUS AUREUS
YesY N No
YesY N No
YesY N No
YesY N No
YesY N No
YesY N No
YesY N No
YesY N No
YesY N No
YesY N No
IF E COLI
IF KLEBSIELLA SPP
IF STREPTOCOCCUS PNEUMONIAE
Positive blood culture result:
On specimens collected within 72 hours of hospital admission Y Yes N No
Skip to Microbiological tests performed on pleural fluid
N Not tested
IF YES
UK REMAP‐CAP Case Report Form 3, V8 dated 20210226 Page 3 of 4 www.remapcap.org
Participant Study Number
Microbiology Patient Initials
Microbiological tests performed on pleural fluid:On specimens collected within 7 days of hospital admission (e.g. culture, PCR)
Skip to Positive lower respiratory tract specimen culture
Positive pleural aspirate culture result:
Which organisms were detected:(check all that apply)
Acinetobacter spp
Escherichia coli
Haemophilus influenzae
Burkholderia pseudomallei
Klebsiella spp
Pseudomonas aeruginosa
Staphylococcus aureus
Moraxella catarrhalis
Streptococcus pneumoniae
Streptococcus pyogenes
Coagulase negative staphylococci
Corynebacterium, Bacillus spp, Micrococcus, Propionibacterium
Other, specify
Streptococcus agalactiae
Reported as resistant to ceftazidime and/or piperacillin‐tazobactam:
Reported as resistant to meropenem and/or imipenem:
On specimens collected within 7 days of hospital admission Y N
Skip to PCR performed on pleural fluid
IF ACINETOBACTER SPP
Yes No
Reported as resistant to ceftazidime and/or piperacillin‐tazobactam:
Reported as resistant to meropenem and/or imipenem:
Reported as methicillin‐resistant staphylococcus aureus:
Reported as resistant to erythromycin and/or azithromycin:
Reported as resistant to penicillin:
Reported as resistant to moxifloxacin, norfloxacin and/or levofloxacin:
Reported as resistant to ceftriaxone and/or ceftazidime:
Reported as resistant to meropenem and/or imipenem:
IF YES
Reported as resistant to ceftriaxone and/or ceftazidime:
Reported as resistant to meropenem and/or imipenem:
IF PSEUDOMONAS AERUGINOSA
IF STAPHYLOCOCCUS AUREUS
IF E COLI
PCR performed on pleural fluid:On specimens collected within 7 days of hospital admission
Y Yes N No Skip to Positive lower respiratory tract specimen culturePositive for Streptococcus pneumoniae:
On specimens collected within 7 days of hospital admission
YesY N
IF YES
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
No
IF KLEBSIELLA SPP
3.0 PLEURAL ASPIRATE
IF STREPTOCOCCUS PNEUMONIAE
IF YES
UK REMAP‐CAP Case Report Form 3, V8 dated 20210226 Page 4 of 4 www.remapcap.org
Participant Study Number
Microbiology Patient Initials
Reported as methicillin‐resistant staphylococcus aureus:
Reported as resistant to erythromycin and/or azithromycin:
Reported as resistant to penicillin:
IF E COLI
IF STREPTOCOCCUS PNEUMONIAE
Reported as resistant to moxifloxacin, norfloxacin and/or levofloxacin:
Reported as resistant to ceftazidime and/or piperacillin‐tazobactam:
Reported as resistant to meropenem and/or imipenem:
Reported as resistant to ceftriaxone and/or ceftazidime:
Reported as resistant to meropenem and/or imipenem:
Reported as resistant to ceftriaxone and/or ceftazidime:
Reported as resistant to meropenem and/or imipenem:
IF STAPHYLOCOCCUS AUREUS
On specimens collected within 7 days of hospital admission
Positive lower respiratory tract or lung tissue specimen:
4.0 IMMUNOCOMPROMISED PATIENTS
Which organisms were detected:
Y Yes N No N Not tested
(check all that apply)
Aspergillus
Mucormycosis species
Nocardia species
Cryptococcus species
Non‐TB mycobacteria
Pneumocystis
Tuberculosis
Varicella zoster virus
None of the above
Reported as resistant to ceftazidime and/or piperacillin‐tazobactam:
Reported as resistant to meropenem and/or imipenem:
IF ACINETOBACTER SPP
(This question will appear on the eCRF if applicable)
IF KLEBSIELLA SPP
IF YES
Positive lower respiratory tract specimen culture: On specimens collected within 72 hours of hospital admission Y Yes N No
Skip to section 2 (if applicable)
N Not tested
Which organisms were detected: (check all that apply)
IF YES
Acinetobacter spp
Escherichia coli
Haemophilus influenzae
Burkholderia pseudomallei
Klebsiella spp
Pseudomonas aeruginosa
Moraxella catarrhalis
Staphylococcus aureus
Streptococcus pneumoniae
Streptococcus agalactiae
Streptococcus pyogenes
None of the above
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
Y NYes No
IF PSEUDOMONAS AERUGINOSA
UK REMAP‐CAP Case Report Form 4, V8 dated 20210226 Page 1 of 2 www.remapcap.org
Collect daily data for the duration of the ICU admission (censored at study day 28). If the patient is allocated to fixed course steroid, collect corticosteroid administration up until D9 while on ward.
. e.g. 0.21
D D M M M Y Y Y Y e.g. 18/JUL/2018
1.0 STUDY DAY
Study day
2.0 DAILY TREATMENTS
Renal replacement therapy:
Extended Cardiovascular SOFA score:
YesY
Date
Study days (01‐28)
Corresponding PaO2:
FiO2 associated with lowest P/F ratio:
kPa.
Airway:
High flow nasal prong oxygen therapy:
Non invasive ventilation: Yes NY
TEO Maintaining own Tracheostomy Endotracheal tube
Hours of invasive mechanical ventilation: hours (0‐24)
N Not recordedmmHg
N No
Corresponding PEEP: cmH2O
Participant Study Number
Daily Patient Initials
Yes NY No
IF ETT or TT
Yes NY NoExtracorporeal gas exchange:
Received: Extracorporeal membrane oxygenation (ECMO)
Extracorporeal carbon dioxide removal (ECCO2R)
IF YES
(check all that apply)
(check one)
IF MAINTAINING OWN
PLATFORM
0 1 2 3 4(check one)
4+
No
Patient location on study day Physical ICU Re‐purposed ICU
Patient in ICU during this day Yes NY No
P Patient receiving APRV
UK REMAP‐CAP Case Report Form 4, V8 dated 20210226 Page 2 of 2 www.remapcap.org
Participant Study Number
Daily Patient Initials
CORTICOSTEROID DOMAIN
3.0 CORTICOSTEROID ADMINISTRATION
Was a corticosteroid administered on this study day:
Name of corticosteroid
Total daily dose:
Yes NY No
mg
Hydrocortisone (oral)
Betamethasone
Methylprednisolone
Prednisolone
Prednisone
Triamcinolone
Dexamethasone
Yes NY No
Was this dose administered for the patient’s initial episode of CAP or its complications:
What was the corticosteroid administered for:
IF NO
Hydrocortisone (IV)
IF YES
Skip this section
1.0 STUDY DAY
Study day
2.0 DAILY TREATMENTS
GLOBAL REMAP‐CAP Case Report Form V2.1 dated 20190129 Page 1 of 2 www.remapcap.org
Renal replacement therapy:
Extended Cardiovascular SOFA score:
Date
Corresponding PaO2:
FiO2 associated with lowest P:F ratio:
Airway:
High flow nasal prong oxygen therapy:
Non invasive ventilation:
Hours of invasive mechanical ventilation:
Corresponding PEEP:
Daily
Extracorporeal gas exchange:
Received:
A study day is the same as an ICU chart day
Highest level of airway support received on that study day
Calendar date at the start of that study day
Gas flow rate must be at least 20 litres per minute & FiO2 must be greater than 0.21
If received for at least one continuous hour, includes CPAP, BiPAP and NIPPV
Total hours of IPPV the patient received on that day, if the patient received less than one hour enter 00hrsIf multiple episodes round part hours to the closest hour
Associated with the lowest P:F ratio taken that day while the patient was receiving IPPVIf no ABG, enter highest FiO2 administered while the patient was receiving IPPV
Associated with the lowest P:F ratio taken that day and the FiO2 entered aboveIf the patient has not had an ABG performed check the NOT RECORDED
Refer to the Completion Guidelines for the definition and assistance
If received any form of continuous, Intermittent haemodialysis, Slow Low Efficiency Dialysis or Peritoneal dialysis on that study day
Check all types of extracorporeal gas exchange received on that study day
If received any extracorporeal support, for either oxygenation or carbon dioxide removal at anytime on that study day
Associated with the lowest P:F ratio taken that day and the FiO2 and PaO2 entered aboveIf no ABG was taken enter the PEEP the patient was receiving at the time of the HIGHEST FiO2 recorded above was takenIf the patient did not receive any PEEP (e.g. T‐piece) enter zero (00)
Refer to the Completion Guidelines for more information
Guidance
(Censored at study day 28 (inclusive))
PLATFORM
All treatments must be administered for at least 1‐hour If the ICU Chart only records hourly treatments the treatment must have been recorded for two consecutive hours
(Censored at study day 28 (inclusive))
Patient in ICU during this dayDuring a pandemic if the patient is located in an area that is capable of providing ICU‐level care (NIV with sealed mask, IMV, or vasopressors via continuous infusion), select YES
Patient in ICU during this day
Physical ICU is an area normally designated as any form of ICU. This includes being cared for in an ICU that does does not normally care for medical or respiratory failure patients, such as a surgical ICU, cardiothoracic ICU, or neurosurgical ICU.An area not usually designated as an ICU includes an area of the hospital that was not designated as an ICU prior to the pandemic. Examples may include a High Dependency Unit, a post‐operative recovery room, operating theatre, or general ward area.If a patient is located in both areas on the same study day, select the area in which they spent the longest period of time on that study day.
UK REMAP‐CAP Case Report Form 5, V8 dated 20210226 Page 1 of 12 www.remapcap.org
Participant Study Number
Medication AdministrationPatient Initials
Date last dose administered:Initial prescribed frequency: Prescribed route of administration:
Date & time first dose administered:Antibiotic name:
PLATFORM
1.0 ANTIBIOTIC COURSE ADMINISTRATION (New course censored at study day 14 (inclusive))
(Textbox) (Check one) (Censored at hospital discharge)
Prescribed dose:
(Check one)
D D M M M YY Y Ye.g. 18/JUL/2018
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
, mg
g.
I Intravenous
E Enteral
D D M M M YY Y Ye.g. 18/JUL/2018
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
, mg
g.
I Intravenous
E Enteral
D D M M M YY Y Ye.g. 18/JUL/2018
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,mg
g.
I Intravenous
E Enteral
Form 5
Continuous infusion
Daily
8 hourly
12 hourly
6 hourly
STAT
4 hourly
Intermittent
depending on levels
Continuous infusion
Daily
8 hourly
12 hourly
6 hourly
STAT
4 hourly
Intermittent
depending on levels
Continuous infusion
Daily
8 hourly
12 hourly
6 hourly
STAT
4 hourly
Intermittent
depending on levels
General Guidance Enter all medications administered between arrival at the randomising hospital and the end of study day 14. Enter all statins administered between arrival at the randomising hospital and the end of study day 28. Include medications administered prior to randomisation (e.g. medications administered in ED or on a ward) even if not continued in ICU. If the patient is randomised on a ward and later admitted to ICU collect 14 days of administration while in ICU (only include this for regions randomising to moderate). Where a STAT dose of the same medication is received prior to the administration of a regular course, record as one entry. Administration of corticosteroids within the Corticosteroid Domain should be entered on the daily form.
Enter a new course if:- the same agent was switched from IV to enteral administration (and vice versa)- the medication has been ceased/interrupted for more than 36 hoursDo not enter a new course if:- the initial prescribed frequency was changed- the initial prescribed dose was changed
UK REMAP‐CAP Case Report Form 5, V8 dated 20210226 Page 2 of 12 www.remapcap.org
D D M M M YY Y Y
Participant Study Number
Medication AdministrationPatient Initials
Date last dose administered:Initial prescribed frequency:
Prescribed route of administration:
Date & time first dose administered:Antiviral name:
e.g. 18/JUL/2018
PLATFORM
2.0 ANTIVIRAL ADMINISTRATION (New course censored at study day 14 (inclusive))
Record only selected antiviral medicationsGeneric antiviral names only
(Check one) (Censored at hospital discharge)(Check one)
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,mg
g.
I Intravenous
E Enteral
Continuous infusion
Daily
8 hourly
12 hourly
6 hourly
STAT
4 hourly
Form 5
Intermittent
depending on levels
Oseltamivir
Peramivir
Prescribed dose:
D M M M YY Y Ye.g. 18/JUL/2018
mg
g.
I Intravenous
E Enteral
Continuous infusion
Daily
8 hourly
12 hourly
6 hourly
STAT
4 hourly
Intermittent
depending on levels
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,
Hydroxychloroquine
Lopinavir/ritonavir (Kaletra)
Laninamivir octanoate
Amantadine
Zanamivir
Chloroquine
Remdesivir
Unifenovir (arbidol)
Darunavir/cobicistat
Favipiravir
Rimantadine
Baloxavir
Ribavirin
Oseltamivir
Peramivir
Hydroxychloroquine
Lopinavir/ritonavir (Kaletra)
Laninamivir octanoate
Amantadine
Zanamivir
Chloroquine
Remdesivir
Unifenovir (arbidol)
Darunavir/cobicistat
Favipiravir
Rimantadine
Baloxavir
Ribavirin
D
UK REMAP‐CAP Case Report Form 5, V8 dated 20210226 Page 3 of 12 www.remapcap.org
Participant Study Number
Medication AdministrationPatient Initials
Form 5
PLATFORM
Total dose (crushed tablet):Study Day:Study Date:
D D M M M Y Y Y Y mg
Lopinavir/ritonavir administered:
3.0 ADMINISTRATION OF LOPINAVIR/RITONAVIRThis CRF page is only required if Lopinavir/Ritonavir was administered during first 14 days
If no lopinavir/ritonavir was administered via this route on this study day, enter 0 (zero)
Total dose (swallowed/dissolved/suspension):
1 Y Yes N No mg
D D M M M Y Y Y Y mg2 Y Yes No mg
D D M M M Y Y Y Y mg3 Y Yes No mg
N
N
D D M M M Y Y Y Y mg4 Y Yes N No mg
D D M M M Y Y Y Y mg5 Y Yes No mg
D D M M M Y Y Y Y mg6 Y Yes No mg
N
N
D D M M M Y Y Y Y mg7 Y Yes N No mg
D D M M M Y Y Y Y mg8 Y Yes No mg
D D M M M Y Y Y Y mg9 Y Yes No mg
N
N
D D M M M Y Y Y Y mg10 Y Yes No mgN
D D M M M Y Y Y Y mg11 Y Yes N No mg
D D M M M Y Y Y Y mg13 Y Yes mg
D D M M M Y Y Y Y mg14 Y Yes No mgN
N No
D D M M M Y Y Y Y mg12 mgY Yes N No
UK REMAP‐CAP Case Report Form 5, V8 dated 20210226 Page 4 of 12 www.remapcap.org
Participant Study Number
Medication AdministrationPatient Initials
Form 5
PLATFORM
Date last dose administered:Initial prescribed frequency:
Prescribed route of administration:
Date & time first dose administered:Agent name:
(Check one) (Censored at hospital discharge)(Check one)
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
, mg
g.
I Intravenous
E Enteral
Continuous infusion
Daily
8 hourly
12 hourly
6 hourly
STAT
4 hourly
Intermittent
depending on levels
Interferon‐ß 1a
Interferon‐ß 1b
Interferon‐α
Interferon‐γ
IL1‐Ra (Anakinra (IL1‐Ra))
Tocilizumab
Prescribed dose:
D M M M YY Y Ye.g. 18/JUL/2018
mg
g.
I Intravenous
E Enteral
Continuous infusion
Daily
8 hourly
12 hourly
6 hourly
STAT
4 hourly
Intermittent
depending on levels
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,
4.0 IMMUNE MODULATION ADMINISTRATION (New course censored at study day 14 (inclusive))
I Inhaled
ISubcutaneous or intra‐muscular
D
D M M M YY Y Ye.g. 18/JUL/2018
D
I Inhaled
ISubcutaneous or intra‐muscular
(Check one)
Sarilumab
Interferon‐ß 1a
Interferon‐ß 1b
Interferon‐α
Interferon‐γ
IL1‐Ra (Anakinra (IL1‐Ra))
Tocilizumab
Sarilumab
(Check one)
UK REMAP‐CAP Case Report Form 5, V8 dated 20210226 Page 5 of 12 www.remapcap.org
Participant Study Number
Medication AdministrationPatient Initials
Form 5
PLATFORM
Date & time infusion ceased:Date & time infusion commenced:Agent name:(Censored at hospital discharge)
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
, ml
Volume transfused:
D M M M YY Y Ye.g. 18/JUL/2018
mlD D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,
Pandemic convalescent plasma
Intravenous immunoglobulin (non‐pandemic specific)
5.0 IMMUNOMODULATORY AND ANTIBODY ADMINISTRATION (New course censored at study day 14 (inclusive))
D
D M M M YY Y Ye.g. 18/JUL/2018
D
(Check one)
H
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
H
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,
,
Donation number:(Textbox)
D M M M YY Y Ye.g. 18/JUL/2018
mlD D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
, D
H
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,
D M M M YY Y Ye.g. 18/JUL/2018
mlD D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
, D
H
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,
D M M M YY Y Ye.g. 18/JUL/2018
mlD D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
, D
H
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,
Pandemic hyperimmune globulin
Pandemic convalescent plasma
Intravenous immunoglobulin (non‐pandemic specific)
Pandemic hyperimmune globulin
Pandemic convalescent plasma
Intravenous immunoglobulin (non‐pandemic specific)
Pandemic hyperimmune globulin
Pandemic convalescent plasma
Intravenous immunoglobulin (non‐pandemic specific)
Pandemic hyperimmune globulin
Pandemic convalescent plasma
Intravenous immunoglobulin (non‐pandemic specific)
Pandemic hyperimmune globulin
UK REMAP‐CAP Case Report Form 5, V8 dated 20210226 Page 6 of 12 www.remapcap.org
D D M M M YY Y Y
Participant Study Number
Medication AdministrationPatient Initials
Date last dose administered:Initial prescribed frequency:
Prescribed route of administration:
Date & time first dose administered:Medication name:
e.g. 18/JUL/2018
PLATFORM
6.0 ANTICOAGULANT / ANTIPLATELET AGENT ADMINISTERED AS STAT OR INTERMITTENT DOSING
Record only selected anticoagulant medicationsGeneric anticoagulant names only
(Check one) (Censored at hospital discharge)(Check one)
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,mg
mcg
I Intravenous
S Subscutaneous
Daily
8 hourly
12 hourly
6 hourly
STAT
4 hourly
Form 5
Intermittent
depending on levels
Unfractionated heparin
Fraxiparine
Prescribed dose:
Enoxaparin
Dalteparin
Tinzaparin
Nadroparin
Apixaban
Argatroban
Rivaroxaban
Edoxaban
Dabigatran
Bilvalirudin
Acetylsalicylic acid (Aspirin)
Fondaparinux
Warfarin
Clopidogrel
Ticlopidine
Ticagrelor
Prasugrel
Dipyridamole
Dipyridamole/aspirin
Abciximab
Eptifibatide
Triofiban
E EnteralIU
(New course censored at study day 14 (inclusive))
(Check one)
UK REMAP‐CAP Case Report Form 5, V8 dated 20210226 Page 7 of 12 www.remapcap.org
D D M M M YY Y Y
Participant Study Number
Medication AdministrationPatient Initials
Date infusion ceased:Initial prescribed frequency:
Prescribed route of administration:
Date & time infusion commenced:Medication name:
e.g. 18/JUL/2018
PLATFORM
6.1 ANTICOAGULANT / ANTIPLATELET AGENT ADMINISTERED AS A CONTINUOUS INFUSION
Record only selected anticoagulant medicationsGeneric anticoagulant names only
(Check one) (Censored at hospital discharge)
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,mg/hr
mcg/hr
I Intravenous
HInto haemofilter
Continuous infusion
Form 5
Unfractionated heparin
Prescribed initial infusion rate:
Argatroban
Bilvalirudin
Abciximab
Eptifibatide
TriofibanIU/hr
(New course censored at study day 14 (inclusive))
D D M M M YY Y Ye.g. 18/JUL/2018
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,mg/hr
mcg/hr
I Intravenous
HInto haemofilter
Continuous infusion Unfractionated heparin
Argatroban
Bilvalirudin
Abciximab
Eptifibatide
TriofibanIU/hr
D D M M M YY Y Ye.g. 18/JUL/2018
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,
mcg/hr
I Intravenous
HInto haemofilter
Continuous infusion Unfractionated heparin
Argatroban
Bilvalirudin
Abciximab
Eptifibatide
TriofibanIU/hr
mg/hr
D D M M M YY Y Ye.g. 18/JUL/2018
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,
mcg/hr
I Intravenous
HInto haemofilter
Continuous infusion Unfractionated heparin
Argatroban
Bilvalirudin
Abciximab
Eptifibatide
TriofibanIU/hr
mg/hr
(Check one)
UK REMAP‐CAP Case Report Form 5, V8 dated 20210226 Page 8 of 12 www.remapcap.org
D D M M M YY Y Y
Participant Study Number
Medication AdministrationPatient Initials
Date last dose administered:Initial prescribed frequency:
Prescribed route of administration:
Date & time first dose administered:Medication name:
e.g. 18/JUL/2018
PLATFORM
7.0 VITAMIN C (New course censored at study day 14 (inclusive))
Record only selected antiviral medicationsGeneric antiviral names only
(Check one) (Censored at hospital discharge)(Check one)
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,mg
g.
I Intravenous
E Enteral
Continuous infusion
Daily
8 hourly
12 hourly
6 hourly
STAT
4 hourly
Form 5
Intermittent
depending on levels
Vitamin C
Prescribed dose:
D M M M YY Y Ye.g. 18/JUL/2018
mg
g.
I Intravenous
E Enteral
Continuous infusion
Daily
8 hourly
12 hourly
6 hourly
STAT
4 hourly
Intermittent
depending on levels
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,
Thiamine
Vitamin C
Thiamine
D
(Check one)
UK REMAP‐CAP Case Report Form 5, V8 dated 20210226 Page 9 of 12 www.remapcap.org
D D M M M YY Y Y
Participant Study Number
Medication AdministrationPatient Initials
Date last dose administered:Prescribed daily frequency:
Prescribed route of administration:
Date & time first dose administered:Medication name:
e.g. 18/JUL/2018
PLATFORM
8.0 STATIN ADMINISTRATION (New course censored at study day 28 (inclusive))
Record only selected medicationsGeneric statin names only (Censored at hospital discharge)(Check one)
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,mg E Enteral Daily
8 hourly
12 hourly
6 hourly
4 hourly
Form 5
Simvastatin
Prescribed dose:
D M M M YY Y Ye.g. 18/JUL/2018
mg E Enteral Daily
8 hourly
12 hourly
6 hourly
4 hourly
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,
Atorvastatin
D
Rosuvastatin
Pravastatin
Lovastatin
Simvastatin
Atorvastatin
Rosuvastatin
Pravastatin
Lovastatin
UK REMAP‐CAP Case Report Form 5, V8 dated 20210226 Page 10 of 12 www.remapcap.org
D D M M M YY Y Y
Participant Study Number
Medication AdministrationPatient Initials
Date last dose administered:Prescribed daily frequency:
Prescribed route of administration:
Date & time first dose administered:Medication name:
e.g. 18/JUL/2018
PLATFORM
9.0 CORTICOSTEROID ADMINISTRATION (New course censored at study day 14 (inclusive)). Pandemic only.
Record only selected medicationsGeneric steroid names only (Censored at hospital discharge)(Check one)
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,mg Daily
8 hourly
12 hourly
6 hourly
4 hourly
Form 5
Hydrocortisone
Prescribed dose:
D M M M YY Y Ye.g. 18/JUL/2018
mg Daily
8 hourly
12 hourly
6 hourly
4 hourly
D D M M M Y Y Y Y
H
e.g. 01/JUN/2018
e.g. 8:05pm = 20:05hours
: M MH 24 hour clock
,
Betamethasone
D
Dexamethasone
Methylprednisolone
Prednisolone
Prednisone
Triamcinolone
Hydrocortisone
Betamethasone
Dexamethasone
Methylprednisolone
Prednisolone
Prednisone
Triamcinolone
I Intravenous
E Enteral
I Intravenous
E Enteral
(Check one)
UK REMAP‐CAP Case Report Form 5, V8 dated 20210226 Page 11 of 12 www.remapcap.org
D M M M YY Y Y
Participant Study Number
Medication AdministrationPatient Initials
Date course ceased:Date & time course commenced:Medication name:
e.g. 18/JUL/2018
PLATFORM
10.0 RENIN‐ANGIOTENSIN SYSTEM MODULATOR ADMINISTRATION (Required for patients randomised to ACE2 RAS domain)
Record only selected RAS medicationsGeneric names only (Censored at hospital discharge)
D D M M M Y Y Y Y H
e.g. 01/JUN/2018 e.g. 8:05pm = 20:05hours
: M MH 24 hour clock,
Form 5
Losartan
Olmesartan
D M M M YY Y Ye.g. 18/JUL/2018
D D M M M Y Y Y Y H
e.g. 01/JUN/2018 e.g. 8:05pm = 20:05hours
: M MH 24 hour clock,
Valsartan
Candesartan
Irbesartan
Telmisartan
Ramipril
Captopril
Lisinopril
Perindopril
Enalapril
Trandolapril
DMX‐200
D
D
Losartan
Olmesartan
Valsartan
Candesartan
Irbesartan
Telmisartan
Ramipril
Captopril
Lisinopril
Perindopril
Enalapril
Trandolapril
DMX‐200
D M M M YY Y Ye.g. 18/JUL/2018
D D M M M Y Y Y Y H
e.g. 01/JUN/2018 e.g. 8:05pm = 20:05hours
: M MH 24 hour clock, DLosartan
Olmesartan
Valsartan
Candesartan
Irbesartan
Telmisartan
Ramipril
Captopril
Lisinopril
Perindopril
Enalapril
Trandolapril
DMX‐200
UK REMAP‐CAP Case Report Form 5, V8 dated 20210226 Page 12 of 12 www.remapcap.org
Participant Study Number
Medication AdministrationPatient Initials
Form 5
PLATFORM
Was the medication withheld at any time on this study day:
Study Day:Study Date:
D D M M M Y Y Y Y
11.0 RENIN‐ANGIOTENSIN SYSTEM MODULATOR – DAILY ADMINISTRATION (Required for patients randomised to ACE2 RAS domain)
Total dose administered:
mg
D D M M M Y Y Y Y mg
D D M M M Y Y Y Y mg
Total dose administered on each study day
Y Yes N No
Reason for withholding medication
Hyperkalemia
Significant renal impairment or deterioriating renal function
Significant exposure to nephrotoxic agents
Clinically‐relevant hypotension
Angioedema (ACEi intervention only)
Other
…………………………………..………Specify:
(check one)
…………………………………..………..………..……………………………………..………..……...……..…
Hyperkalemia
Significant renal impairment or deterioriating renal function
Significant exposure to nephrotoxic agents
Clinically‐relevant hypotension
Angioedema (ACEi intervention only)
Other
…………………………………..………Specify:
…………………………………..………..………..……………………………………..………..……...……..…
Hyperkalemia
Significant renal impairment or deterioriating renal function
Significant exposure to nephrotoxic agents
Clinically‐relevant hypotension
Angioedema (ACEi intervention only)
Other
…………………………………..………Specify:
…………………………………..………..………..……………………………………..………..……...……..…
e.g. 01/JUN/2018
e.g. 01/JUN/2018
e.g. 01/JUN/2018
IF YES
Y Yes N No IF YES
Y Yes N No IF YES
Losartan
Olmesartan
Valsartan
Candesartan
Irbesartan
Telmisartan
Ramipril
Captopril
Lisinopril
Perindopril
Enalapril
Trandolapril
DMX‐200
Choose one RAS modulator agent per sheet and record daily data collection for each study day (up to study day 28 max) between the start and end of the course.
UK REMAP‐CAP Case Report Form 6, V8 dated 20210226 Page 1 of 7 www.remapcap.org
1.0 ICU DISCHARGE
A Alive D Deceased
ICU discharge date & time:
Status:
2.0 ICU READMISSION
ICU readmission: Yes NY No Skip to section 3
ICU readmission date & time:
ICU discharge date & time:
Participant Study Number
Discharge Patient Initials
IF YESD D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
(check one)
PLATFORM
(First ICU discharge)
(ICU readmissions)
*Date and time of last organ support in ICU: D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
NNever Received
*Date and time of first organ support in ICU this readmission: D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
2nd ICU readmission: Yes NY No Skip to section 3
ICU readmission date & time:
ICU discharge date & time:
IF YESD D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
*Date and time of first organ support in ICU this readmission:
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
*Date and time of last organ support in ICU this readmission:
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
*Date and time of last organ support in ICU this readmission: D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
Did the patient receive organ support during this ICU admission Yes NY No
IF YES
Did the patient receive organ support during this ICU admission Yes NY No
IF YES
Discharge
3.0 HOSPITAL DISCHARGE (Censored at hospital discharge)
Hospital discharge date & time:
Dialysis at hospital discharge: Yes NY No
Last creatinine: µmol/L mg/dL.
IF NO
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
Skip to Hospital discharge date & time
N Not recorded
* = Only required for Pandemic Infection Suspected or Confirmed Patients
UK REMAP‐CAP Case Report Form 6, V8 dated 20210226 Page 2 of 7 www.remapcap.org
Discharge
3.0 HOSPITAL DISCHARGE
Ultimate hospital discharge date: D D M M M Y Y Y Y
e.g. 01/JUN/2018
S Still in hospital on study day 90
(Censored at hospital discharge)
Status at ultimate hospital A Alive D Deceased U Unable to ascertain
IF TRANSFER TO ANOTHER ACUTE HOSPITAL
*Was patient admitted to ICU during this hospital admission:
Yes NY No
ICU admission date & time:
ICU discharge date & time:
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
*Date and time of first organ support in ICU this readmission:
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
If No, Skip to 4.0 Co‐enrolment
Readmission: Yes NY No If No, Skip to 4.0 Co‐enrolment
ICU readmission date & time:
ICU discharge date & time:
IF YESD D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
*Date and time of first organ support in ICU this readmission:
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
Participant Study Number
Patient Initials
Form Discharge
PLATFORM
*Date and time of last organ support in ICU this readmission:
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
UUnable to ascertain
UUnable to ascertain
UUnable to ascertain
UUnable to ascertain
UUnable to ascertain
*Date and time of last organ support in ICU this readmission:
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
UUnable to ascertain
IF YESU
Unable to ascertain
UUnable to ascertain
Destination:
Nursing home or long‐term care facililty
Home Rehabilitation hospital(check one)
A Alive D Deceased
Transfer to another acute hospital
IF ALIVE
Skip to Domain‐Specific section(s)(check one)
Did the patient receive organ support during this ICU admission Yes NY No
IF YES
Did the patient receive organ support during this ICU admission Yes NY No
IF YES
Status:
* = Only required for Pandemic Infection Suspected or Confirmed Patients
UK REMAP‐CAP Case Report Form 6, V8 dated 20210226 Page 3 of 7 www.remapcap.org
Participant Study Number
Patient Initials
Form Discharge
4.0 CO‐ENROLMENT
Co‐enrolled in another study: Yes NY No Skip to 5.0 Platform endpoints
IF YES
5.0 PLATFORM ENDPOINTS (Censored at hospital discharge)
Has PCR testing for SARS‐CoV‐2 been completed: Yes NY No
+ Positive ‐ Negative
SARS‐CoV‐2 PCR test results:
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
+ Positive ‐ Negative D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
+ Positive ‐ Negative D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
IF YES
between start and end of study day 14 after first randomisation
Hospitalised, no supplemental oxygen
Invasive mechanical ventilation plus additional organ support (inotrope/vasopressor infusion, renal replacement therapy)
ECMO
Hospitalised, low‐flow oxygen by mask or nasal prongs
Non‐invasive ventilation or high‐flow oxygen
Deceased Unknown
Invasive mechanical ventilation
Select the highest level of organ support on Day 14 after first randomisation:
between start and end of study day 14 after last randomisation
Hospitalised, no supplemental oxygen
Invasive mechanical ventilation plus additional organ support (inotrope/vasopressor infusion, renal replacement therapy)
ECMO
Hospitalised, low‐flow oxygen by mask or nasal prongs
Non‐invasive ventilation or high‐flow oxygen
Deceased Unknown
Invasive mechanical ventilation
Select the highest level of organ support on Day 14 after last randomisation:
Only required for Pandemic Infection Suspected or Confirmed Patients who are alive and in hospital at study day 14
(check one)
(check one)
ATTACC study ID: ……………………………………………………
ASCOT study ID: ………………………………………………………
LOVIT study ID: ………………………………………………………
Other co‐enrolment study name: ……………….…………………………
Other co‐enrolment study name: ……………….…………………………
Other co‐enrolment study name: ……………….…………………………
Other co‐enrolment study name: ……………….…………………………
N Not enrolled in ATTACC
N Not enrolled in ASCOT
N Not enrolled in LOVIT
UK REMAP‐CAP Case Report Form 6, V8 dated 20210226 Page 4 of 7 www.remapcap.org
Participant Study Number
Patient Initials
Form Discharge
7.0 DOMAIN SECONDARY OUTCOMES
MACROLIDE DURATION DOMAIN + COVID‐19 ANTIVIRAL DOMAIN
(Censored at hospital discharge)
Extended‐ Spectrum Beta‐Lactamases producing Escherichia coli and/or Klebsiella spp isolated or detected:
Yes NY No
DDate first positive specimen collected: D M M M Y Y Y Y e.g. 01/JUN/2018
History of this organism during previous hospital admissions: Yes NY No
Skip to CRE/CPE isolated or detected
Carbapenem‐resistant gram‐negative organism isolated or detected: Yes NY No
DDate first positive specimen collected:
D M M M Y Y Y Y e.g. 01/JUN/2018
History of this organism during previous hospital admissions: Yes NY No
Skip to section 6(if applicable)
IF YES
IF YES
Yes N NoDocumented serious ventricular arrhythmia:
Yes NY NoPatient died while not on continuous cardiac monitoring:
Death was unexpected and sudden:
Y
Yes NY No
IF YES
IF NO
Date & time of serious ventricular arrhythmia:
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
IF YES
ANTIBIOTIC DOMAIN
6.0 MULTI‐RESISTANT ORGANISMS (Censored at hospital discharge)
Yes NY NoClostridium difficile toxin detected on a faecal specimen:
Methicillin‐resistant Staphylococcus aureus isolated or detected: Yes NY No
IF YES Date first positive specimen collected:
Date first positive specimen collected:
History of this organism during previous hospital admissions: Yes NY No
Vancomycin‐resistant Enterococcus isolated or detected: Yes NY No
Date first positive specimen collected:
History of this organism during previous hospital admissions: Yes NY No
Skip to MRSA isolated or detected
Skip to VRE isolated or detected
Skip to ESBL isolated or detected
D D M M M Y Y Y Y e.g. 01/JUN/2018
D D M M M Y Y Y Y e.g. 01/JUN/2018
D D M M M Y Y Y Y e.g. 01/JUN/2018
IF YES
IF YES
CORTICOSTEROID DOMAIN8.0 ETOMIDATE ADMINISTRATION (Censored at the end of Day 8)
Etomidate administered between randomisation in the Corticosteroid domain and the end of study day 8:
Yes N NoY
UK REMAP‐CAP Case Report Form 6, V8 dated 20210226 Page 5 of 7 www.remapcap.org
Participant Study Number
Patient Initials
Form Discharge
Number of units of red blood cells transfused:between first randomisation and end of study day 15
Yes NY NoClinically diagnosed acute myocardial infarction:
Date & time of myocardial infarction: D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hoursbetween first randomisation and hospital
discharge
IF YES
THERAPEUTIC ANTICOAGULATION / ANTIPLATELET / IMMUNOGLOBULIN
9.0 DOMAIN‐SPECIFIC ENDPOINTS (Censored at hospital discharge)
If a patient is randomised into the Therapeutic Anticoagulation and Immunoglobulin domains at two different timepoints additional peak troponin tests, major bleeding episodes and RBC tranfusion episodes can be added in the supplementary form and the eCRF.
Peak troponin‐test method:
ng/L or pg/mL N Not recordedng/mL
Test:(check one)
High sensitivity Troponin T Troponin T
Troponin I
Result: .
N Not recorded
ng/mL.ng/L or pg/mLUpper reference limit (99th percentile):
High sensitivity Troponin I
between first randomisation and hospital discharge
Yes N NoMajor bleeding: Y
IF YES
Major bleeding description of event(s): ……………………………………………………………………………………………………...
………………………………………………………………………………………….…………………………………………………………….……………
……………….………………………………………………………………………………………….………………………………………………………..
……………….………………………………………………………………………………………….………………………………………………………..
Date & time of major bleeding event: D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hoursbetween first randomisation and 15 days
after last randomisation
Which one or more of these criteria were met:
Fatal bleeding
Blood loss causing a fall in haemoglobin ≥ 2g/dL
Symptomatic or clinically manifest bleeding in a critical area or organ
(check all that apply)
Blood loss leading to transfusion of ≥ 2 units of red cells or whole blood
Yes NY NoConfirmed deep vein thrombosis: DVT requires confirmation on ultrasound or CT
Date & time of deep vein thombosis: D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hoursbetween first randomisation and hospital
discharge
IF YES
Only required for patients randomised to V3 anticoagulation domain (and antiplatelet going forward)
UK REMAP‐CAP Case Report Form 6, V8 dated 20210226 Page 6 of 7 www.remapcap.org
Participant Study Number
Patient Initials
Form Discharge
Confirmed ischaemic stroke: Yes NY No
Other confirmed thrombotic event:
Critical ischaemia of limb(s)
Mesenteric ischaemia Other(check one)
None
IF OTHER
Other, specify ………………………………………..……………………………………………………………………………………..................................
………………………………………………………………………………………….…………………………………………………………….…………………………..
……………………….………………………………………………………………………………………….………………………………………...……………………..
…………………………….………………………………………………………………………………………….…………………………………...……………………..
Date & time of ischaemic stroke: D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hoursbetween first randomisation and
hospital discharge
IF YES
Date & time of thrombotic event:D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hoursbetween first randomisation and
hospital discharge
IF ANY OPTION OTHER THAN NONE
Confirmed pulmonary emboli: Yes NY No
Date & time of pulmonary emboli: D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hoursbetween first randomisation and
hospital discharge
IF YES
PE requires confirmation on ultrasound or CT
Therapeutic dose anticoagulation commenced for a new clinical indication:
Yes NY No
IF YES
Commencement date:D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
between randomisation and hospital discharge
Indication:
Atrial Fibrillation
Venous thromboembolism
ECMO
Arterial thromboembolism
(check all that apply)
COVID‐19 without venous or arterial thromboembolism
RRT
Other
IF OTHER
Specify: ……………………………………..…………………………………………………
Only required for patients randomised to V3 anticoagulation domain (and antiplatelet going forward)
UK REMAP‐CAP Case Report Form 6, V8 dated 20210226 Page 7 of 7 www.remapcap.org
Participant Study Number
Patient Initials
Form Discharge
END OF DISCHARGE CRF
ACE2 RAS DOMAIN
10.0 DOMAIN‐SPECIFIC ENDPOINTS (Censored at hospital discharge)
Did the patient receive renal replacement therapy: Yes NY No
between randomisation to ACE2 domain and hospital discharge
Peak creatinine in first 7 days after randomisation:
Peak creatinine in first 14 days after randomisation:
Peak ALT in first 14 days after randomisation:
Peak AST in first 14 days after randomisation:
Peak bilirubin in first 14 days after randomisation:
Clinically relevant hypotension while admitted to a ward:
between randomisation and 168h after randomisation to ACE2 domain
N Not recordedµmol/L mg/dL.
Between randomisation and 336h after randomisation to ACE2 domain:
N Not recordedµmol/L mg/dL.
N Not recorded
N Not recorded
N Not recordedµmol/L mg/dL.
Yes NY Nobetween randomisation and 336h after randomisation to ACE2 domain while not in ICU
IU/L
IU/L
Did the patient develop angioedema: Yes NY Nobetween randomisation to ACE2 domain and end of study day 12
Was treatment for angiodema instituted:
IF YES
Initiation of new treatment for angioedema
No intervention
Ceased ACEi administration
If ‘No intervention’ is selected, other options don’t apply
Page 1 of 4 www.remapcap.orgUK REMAP‐CAP Case Report Form 7, V8 dated 20210226
1.0 AGREEMENT EVENT
Participant Study Number
Consent Patient Initials
PLATFORM (At any time in accordance with your
regions ethical requirements)
Who was approached to provide agreement:
p
Pr Professional legal representative
Personal legal representative
Date & time approached:
IF PROFESSIONAL LEGAL REPRESENTATIVE
Antibiotic Domain Outcome: D DeclinedA Agreement N No outcome
Macrolide Duration Domain Outcome: D DeclinedA Agreement N No outcome
Corticosteroid Domain Outcome: D DeclinedA Agreement N No outcome
(check one)
(check one)
(check one)
N Not applicable
N Not applicable
N Not applicable
Date & time of agreement decision:
P Patient
D D M M M Y Y Y Y H
e.g. 01/JUN/2018 e.g. 8:05pm = 20:05hours
: MH, M
D D M M M Y Y Y Y H
e.g. 01/JUN/2018 e.g. 8:05pm = 20:05hours
: MH, M
Agreement decision:
Permission to use data from the patient’s medical record:
D DeclinedA Agreement N No outcome
(check one)
N Not applicable
Reason for non‐agreement: N Not applicable
IF DECLINED ANY OF THE ABOVE
Skip to Section 2.0 Patient agreement event
Antiviral Domain Outcome: D DeclinedA Agreement N No outcome
COVID‐19 Antiviral Domain Outcome: D DeclinedA Agreement N No outcome
COVID‐19 Immune Mod Domain Outcome: D DeclinedA Agreement N No outcome
(check one)
(check one)
(check one)
N Not applicable
N Not applicable
N Not applicable
Immunoglobulin Domain Outcome: D DeclinedA Agreement N No outcome(check one)
N Not applicable
Therapeutic Anticoagulation Domain Outcome:
D DeclinedA Agreement N No outcome(check one)
N Not applicable
Vitamin C Domain Outcome: D DeclinedA Agreement N No outcome(check one)
N Not applicable
Simvastatin Domain Outcome: D DeclinedA Agreement N No outcome(check one)
N Not applicable
Antiplatelet Domain Outcome: D DeclinedA Agreement N No outcome(check one)
N Not applicable
ACE2 RAS Domain Outcome: D DeclinedA Agreement N No outcome(check one)
N Not applicable
Page 2 of 4 www.remapcap.orgUK REMAP‐CAP Case Report Form 7, V8 dated 20210226
1.0 AGREEMENT EVENT
Participant Study Number
Consent Patient Initials
PLATFORM (At any time in accordance with your
regions ethical requirements)
Date & time approached:
Antibiotic Domain Outcome: D DeclinedA Agreement N No outcome
Macrolide Duration Domain Outcome: D DeclinedA Agreement N No outcome
Corticosteroid Domain Outcome: D DeclinedA Agreement N No outcome
(check one)
(check one)
N Not applicable
N Not applicable
N Not applicable
Date & time of agreement decision:
D D M M M Y Y Y Y H
e.g. 01/JUN/2018 e.g. 8:05pm = 20:05hours
: MH, M
D D M M M Y Y Y Y H
e.g. 01/JUN/2018 e.g. 8:05pm = 20:05hours
: MH, M
Agreement decision:
(check one)
Did the personal legal representative provide agreement: N NoY Yes N Not applicable
IF YES
(check one)
Skip to Section 2.0
Antiviral Domain Outcome: D DeclinedA Agreement N No outcome
COVID‐19 Antiviral Domain Outcome: D DeclinedA Agreement N No outcome
COVID‐19 Immune Mod Domain Outcome: D DeclinedA Agreement N No outcome
(check one)
(check one)
N Not applicable
N Not applicable
N Not applicable
Permission to use data from the patient’s medical record:
D DeclinedA Agreement N No outcome
(check one)
(check one)
N Not applicable
Permission to contact the patient to complete the follow‐up questionnaires:
D DeclinedA Agreement N No outcome
(check one)
N Not applicable
Reason for non‐agreement: N Not applicable
Immunoglobulin Domain Outcome: D DeclinedA Agreement N No outcome N Not applicable(check one)
Therapeutic Anticoagulation Domain Outcome: D DeclinedA Agreement N No outcome N Not applicable(check one)
Vitamin C Domain Outcome: D DeclinedA Agreement N No outcome N Not applicable(check one)
Simvastatin Domain Outcome: D DeclinedA Agreement N No outcome N Not applicable(check one)
IF DECLINED ANY OF THE ABOVE
Antiplatelet Domain Outcome: D DeclinedA Agreement N No outcome N Not applicable(check one)
ACE2 RAS Domain Outcome: D DeclinedA Agreement N No outcome N Not applicable(check one)
Page 3 of 4 www.remapcap.orgUK REMAP‐CAP Case Report Form 7, V8 dated 20210226
(check one)
2.0 PATIENT AGREEMENT EVENT
Participant Study Number
Consent Patient Initials
PLATFORM (At any time in accordance with your
regions ethical requirements)
N NoY YesWas the patient capable of providing agreement during this hospital admission:
Was the patient approached to provide agreement:
Reason not approached:
Date & time approached:
Antibiotic Domain Outcome: D DeclinedA Agreement N No outcome
Macrolide Duration Domain Outcome: D DeclinedA Agreement N No outcome
Corticosteroid Domain Outcome: D DeclinedA Agreement N No outcome
(check one)
(check one)
(check one)
N Not applicable
N Not applicable
N Not applicable
Date & time of agreement decision:
D D M M M Y Y Y Y H
e.g. 01/JUN/2018 e.g. 8:05pm = 20:05hours
: MH, M
D D M M M Y Y Y Y H
e.g. 01/JUN/2018 e.g. 8:05pm = 20:05hours
: MH, M
Agreement decision:
Permission to use data from the patient’s medical record:
D DeclinedA Agreement N No outcome
(check one)
N Not applicable
Permission to contact the patient to complete the follow‐up questionnaires:
D DeclinedA Agreement N No outcome
(check one)
N Not applicable
Reason for non‐agreement: N Not applicable
IF DECLINED ANY OF THE ABOVE
N NoY Yes
IF NO
IF YES
Antiviral Domain Outcome: D DeclinedA Agreement N No outcome
COVID‐19 Antiviral Domain Outcome: D DeclinedA Agreement N No outcome
COVID‐19 Immune Mod Domain Outcome: D DeclinedA Agreement N No outcome
(check one)
(check one)
(check one)
N Not applicable
N Not applicable
N Not applicable
Immunoglobulin Domain Outcome: D DeclinedA Agreement N No outcome N Not applicable(check one)
Therapeutic Anticoagulation Domain Outcome: D DeclinedA Agreement N No outcome N Not applicable(check one)
Vitamin C Domain Outcome: D DeclinedA Agreement N No outcome N Not applicable(check one)
Simvastatin Domain Outcome: D DeclinedA Agreement N No outcome N Not applicable(check one)
Antiplatelet Domain Outcome: D DeclinedA Agreement N No outcome N Not applicable
(check one)
ACE2 RAS Domain Outcome: D DeclinedA Agreement N No outcome N Not applicable
Page 4 of 4 www.remapcap.orgUK REMAP‐CAP Case Report Form 7, V8 dated 20210226
Participant Study Number
Consent Patient Initials
PLATFORM
Date agreement revoked: D D M M M Y Y Y Y e.g. 01/JUN/2018
3.0 AGREEMENT REVOKED(At any time in accordance with your
regions ethical requirements)
Agreement revoked by:
Revoke decision:
Antibiotic Domain Outcome:
Macrolide Duration Domain Outcome:
Corticosteroid Domain Outcome:
(check one)
(check one)
(check one)
Permission to use data from the patient’s medical record:(check one)
Permission to contact the patient to complete the follow‐up questionnaires:(check one)
Reason agreement revoked: N Not applicable
N No changeR Revoked
N No changeR Revoked
N No changeR Revoked
N No changeR Revoked
N No changeR Revoked
Pr Professional legal representative
p Personal legal representative
P Patient
Antiviral Domain Outcome:
COVID‐19 Antiviral Domain Outcome:
COVID‐19 Immune Mod Domain Outcome:
(check one)
(check one)
(check one)
N No changeR Revoked
N No changeR Revoked
N No changeR Revoked
END OF CONSENT CRF
Immunoglobulin Domain Outcome:
Therapeutic Anticoagulation Domain Outcome:
Vitamin C Domain Outcome:
(check one)
(check one)
(check one)
N No changeR Revoked
N No changeR Revoked
N No changeR Revoked
Simvastatin Domain Outcome:(check one)
N No changeR Revoked
Antiplatelet Domain Outcome:(check one)
N No changeR Revoked
ACE2 RAS Domain Outcome:(check one)
N No changeR Revoked
UK REMAP‐CAP Case Report Form 8, V8 dated 20210226 Page 1 of 1 www.remapcap.org
Participant Study Number
Day 21 Patient Initials
1.0 PATIENT STATUS
ICU status:
PLATFORM (PANDEMIC ONLY)(Only complete for patients randomised to one of the COVID‐19 Domains.
Can only be completed from the end of study day 22 onwards)
N No Y Yes
Still in ICU Discharged from ICU
Was the patient discharged and readmitted to ICU prior to the end of study day 22:
Please enter date and time of any admission to and discharge from ICU into Form 6 – Discharge.
Hospital status: Still in hospital Discharged from hospital
D D M M M Y Y Y Y e.g. 18/JUL/2018Assessment date:
END OF D21 CRF
If discharged from ICU enter details in Form 6 – Discharge.
If discharged from hospital enter details in Form 6 – Discharge.
Never admitted to ICU
UK REMAP‐CAP Case Report Form 9, V8 dated 20210226 Page 1 of 1 www.remapcap.org
1.0 VITAL STATUS
Status: D DeceasedA Alive
Date of death: D D M M M Y Y Y Y e.g. 18/JUL/2018
U Unable to ascertain
Date last known alive:
D D M M M Y Y Y Y e.g. 18/JUL/2018Assessment date:
Participant Study Number
Day 90 Patient Initials
D D M M M Y Y Y Y e.g. 18/JUL/2018
(check one)
PLATFORM (Complete as close to but not
on or before study day 90)
SOURCE DOCUMENT
Source:
Follow‐up completed by:
Signature:
P Phone callM Medical Record O Other
IF DECEASED
IF UNABLE TO ASERTAIN
UK REMAP‐CAP Case Report Form 10, V8 dated 20210226 Page 1 of 5 www.remapcap.org
1.0 VITAL STATUS
Home
Nursing home or long‐term care facility
Location on study day 180:
Additional information:
Rehabilitation hospital
Acute care hospital
Hospital ICU
Other, specify
Participant Study Number
Day 180 Patient Initials
Status: D DeceasedA Alive
Date of death: D D M M M Y Y Y Y e.g. 18/JUL/2018
U Unable to ascertain
Date last known alive:
D D M M M Y Y Y Y e.g. 18/JUL/2018Assessment date:
D D M M M Y Y Y Y e.g. 18/JUL/2018
(check one)
(check one)
PLATFORM
2.0 SOURCE DOCUMENT
Source:
Follow‐up completed by:
Signature:
P Phone callM Medical Record O Other
IF ALIVE
IF UNABLE TO ASCERTAIN
(Complete as close to but not on or before study day 180)
IF DECEASED
UK REMAP‐CAP Case Report Form 10, V8 dated 20210226 Page 2 of 5 www.remapcap.org
Language or competence barrier
Unable to contact patient or suitable proxy
Declined to answer subsequent questions
Other, specify
Yes
2.0 D180 SURVEYS
Date completed:
Was the EQSD‐5L completed:
D D M M M Y Y Y Y e.g. 18/JUL/2018
S Same date as Assessment date
Participant Study Number
Day 180 Patient Initials
Reason unable to proceed:(check one)
IF NO
NY No
PLATFORM FOLLOW‐UP QUESTIONNAIRES(Complete on all patients who were alive on study day 180)
Please select ONE option that best describes the patients health TODAY
Mobility: I have no problems with walking around
I have slight problems with walking around
I have moderate problems with walking around
I have severe problems with walking around
I am unable to walk around
Personal care: I have no problems with washing or dressing myself
I have slight problems with washing or dressing myself
I have moderate problems with washing or dressing myself
I have severe problems with washing or dressing myself
I am unable to wash or dress myself
(check one)
(check one)
Usual activities I have no problems doing my usual activities
I have slight problems doing my usual activities
I have moderate problems doing my usual activities
I have severe problems doing my usual activities
I am unable to do my usual activities
(check one)
3.0 EQ5D‐5L
Person interviewed: Patient PP Proxy
Do they live with the patient? Yes NY NoIF PROXY
Were any of the survey tools completed: Yes
Skip to date completed
NY No
UK REMAP‐CAP Case Report Form 10, V8 dated 20210226 Page 3 of 5 www.remapcap.org
Please select ONE option that best describes the patients health TODAY
Pain/discomfort I have no pain or discomfort
I have slight pain or discomfort
I have moderate pain or discomfort
I have severe pain or discomfort
I am extreme pain or discomfort
Anxiety/depression: I am not anxious or depressed
I am slightly anxious or depressed
I am moderately anxious or depressed
I am severely anxious or depressed
I am extremely anxious or depressed
We would like to know how good or bad your health is TODAY:
On a scale from 0 to 100 100 means the BEST health you can imagine 0 means the WORST health you can imagine Mark an X on the scale to indicate how your health is TODAY Now, please write the number you marked on the scale in the box
below
The best health you can imagine
YOUR HEALTH TODAY:
The worst health you can imagine
Participant Study Number
Day 180 Patient Initials
(check one)
(check one)
Health today scale
UK REMAP‐CAP Case Report Form 10, V8 dated 20210226 Page 4 of 5 www.remapcap.org
4.0 WHODAS 2.0
Was the WHODAS Completed:
Standing for long periods such as 30 minutes?
Yes NY No
How many years in all did you spend studying in school, college or university: years
In the past 30 days, how much difficulty did you have doing the following activities:
1 2 3 4 5
NONE MILD MODERATE SEVERE EXTREME OR CANNOT DO
1 2 3 4 5
1 2 3 4 5
1 2 3 4 5
1 2 3 4 5
Taking care of your household responsibilities?
Learning a new task, for example learning how to get to a new place?
How much of a problem did you have joining in community activities (for example, festivities, religious or other activities) in the same way as anyone else can?
How much have you been emotionally affected by your health problems?
For each question check one
What is your current marital status: Never married
Currently married
Separated
CohabitingDivorced
Widowed
Which describes your main work status best:
Paid work
Self‐employed
Non‐paid work
Unemployed (health reason)
Keeping house/homemaker
Retired
Student
Unemployed (other reason)
Other, specify
Participant Study Number
Day 180 Patient Initials
For each question check one
In the past 30 days, how much difficulty did you have in:
Concentrating on doing something for ten minutes? 1 2 3 4 5
NONE MILD MODERATE SEVERE EXTREME OR CANNOT DO
1 2 3 4 5
1 2 3 4 5
1 2 3 4 5
1 2 3 4 5
Walking a long distance such as a kilometre?
Washing your whole body?
Getting dressed?
Dealing with people you do not know?
Or equivalent
Maintaining a friendship? 1 2 3 4 5
1 2 3 4 5Your day‐to‐day work/school?
(check one)
(check one)
(Complete on all patients who were alive on study day 180)
UK REMAP‐CAP Case Report Form 10, V8 dated 20210226 Page 5 of 5 www.remapcap.org
Overall, in the past 30 days, how many days were these difficulties present?
In the past 30 days, for how many days were you totally unable to carry out your usual activities or work because of any health condition?
In the past 30 days, not counting the days that you were totally unable, for how many days did you cut back or reduce your usual activities or work because of any health condition?
days
days
days
5.0 BASELINE
Before your ICU admission which describes your main work status best?
Paid work
Self‐employed
Non‐paid work Unemployed (other reason)
Retired
Unemployed (health reason)
Student Other, please specify
Keeping house/homemaker
NYIn the month before your ICU admission were you receiving any treatment for anxiety or depression? Yes No
Participant Study Number
Day 180 Patient Initials
(check one)
(Complete on all patients who were alive on study day 180)
6.0 ETHICS
If you had been able to give consent yourself before we signed you up to the study, would you have agreed to participate in the trial?
Prior to the hospital admission had you ever discussed your participation in research with the person who made the decision for you to participate in the trial?
How acceptable would it be to you if a doctor not involved in the study gave consent for you to be included in the trial instead of a family member?
N Not acceptable A Acceptable U Unsure U Prefer not to answer
When you were admitted to the Intensive Care Unit, you were signed up to take part in REMAP‐CAPThe following questions will help us understand your views on the way we signed you up to the REMAP‐CAP study
As you were unable to make a decision yourself about taking part, a relative or someone similar made that decision for you
Imagine this study had happened during a public health emergency, such as a severe flu outbreak
N NoY Yes U Unsure U Prefer not to answer
N NoY Yes U Unsure U Prefer not to answer
Person interviewed: Patient PP Proxy Nil further on this CRF
(check one)
(check one)
(check one)
N Not applicable
N Not applicable
(This section will appear on the eCRF if applicable)
Form
11
UK REMAP‐CAP Case Report Form 12, V8 dated 20210226 Page 1 of 6 www.remapcap.org
Death
Congenital anomaly
Life threatening
Permanently disabled
Prolongation of (current) hospitalisation or re‐hospitalisation
Diagnosis:
Report type: Initial report FI Follow‐up report F Final report
SAE type:
Medically important
SAE description:
Suspected intervention: Antibiotic MA Macrolide
C Corticosteroid
Unlikely to be related to intervention/participation
Not related to intervention/participation
Possibly related to intervention/participation
Probably related to intervention/participation
Definitely related to intervention/participation
Suspected relationship:(check one)
(check one)
1.0 SERIOUS ADVERSE EVENT DETAILS
General participation G
Participant Study Number
Serious Adverse Event Patient Initials
PLATFORM
(Censored at hospital discharge)
(check all that apply)
(IF ANTIBIOTIC DOMAIN)
Unlikely to be related to intervention/participation
Not related to intervention/participation
Possibly related to intervention/participation
Probably related to intervention/participation
Definitely related to intervention/participation
Suspected relationship:(check one)
Unlikely to be related to intervention/participation
Not related to intervention/participation
Possibly related to intervention/participation
Probably related to intervention/participation
Definitely related to intervention/participation
Suspected relationship:(check one)
(IF MACROLIDE DURATION DOMAIN)
(IF CORTICOSTEROID DOMAIN)
I Antiviral X COVID‐19 Antiviral
Y COVID‐19 Immune modulation therapy P Immunoglobulin
H Therapeutic Anticoagulation L Vitamin C S Simvastatin
B Antiplatelet R ACE2 RAS
UK REMAP‐CAP Case Report Form 12, V8 dated 20210226 Page 2 of 6 www.remapcap.org
Unlikely to be related to intervention/participation
Not related to intervention/participation
Possibly related to intervention/participation
Probably related to intervention/participation
Definitely related to intervention/participation
Suspected relationship:(check one)
1.0 SERIOUS ADVERSE EVENT DETAILS
Participant Study Number
Serious Adverse Event Patient Initials
PLATFORM
(Censored at hospital discharge)
(IF COVID‐19 ANTIVIRAL DOMAIN)
Unlikely to be related to intervention/participation
Not related to intervention/participation
Possibly related to intervention/participation
Probably related to intervention/participation
Definitely related to intervention/participation
Suspected relationship:(check one)
(IF COVID‐19 IMMUNE MODULATION THERAPY DOMAIN)
Unlikely to be related to intervention/participation
Not related to intervention/participation
Possibly related to intervention/participation
Probably related to intervention/participation
Definitely related to intervention/participation
Suspected relationship:(check one)
(IF IMMUNOGLOBULIN DOMAIN)
Unlikely to be related to intervention/participation
Not related to intervention/participation
Possibly related to intervention/participation
Probably related to intervention/participation
Definitely related to intervention/participation
Suspected relationship:(check one)
(IF THERAPEUTIC ANTICOAGULATION DOMAIN)
Unlikely to be related to intervention/participation
Not related to intervention/participation
Possibly related to intervention/participation
Probably related to intervention/participation
Definitely related to intervention/participation
Suspected relationship:(check one)
(IF VITAMIN C DOMAIN)
Unlikely to be related to intervention/participation
Not related to intervention/participation
Possibly related to intervention/participation
Probably related to intervention/participation
Definitely related to intervention/participation
Suspected relationship:(check one)
(IF ANTIVIRAL DOMAIN)
UK REMAP‐CAP Case Report Form 12, V8 dated 20210226 Page 3 of 6 www.remapcap.org
D D M M M Y Y Y Y e.g. 18/JUL/2018Onset date:
Unlikely to be related to intervention/participation
Not related to intervention/participation
Possibly related to intervention/participation
Probably related to intervention/participation
Definitely related to intervention/participation
Suspected relationship:(check one)
1.0 SERIOUS ADVERSE EVENT DETAILS
Participant Study Number
Serious Adverse Event Patient Initials
PLATFORM
(Censored at hospital discharge)
(IF ANTIPLATELET DOMAIN)
Unlikely to be related to intervention/participation
Not related to intervention/participation
Possibly related to intervention/participation
Probably related to intervention/participation
Definitely related to intervention/participation
Suspected relationship:(check one)
(IF SIMVASTATIN DOMAIN)
Unlikely to be related to intervention/participation
Not related to intervention/participation
Possibly related to intervention/participation
Probably related to intervention/participation
Definitely related to intervention/participation
Suspected relationship:(check one)
(IF ACE2 RAS DOMAIN)
UK REMAP‐CAP Case Report Form 12, V8 dated 20210226 Page 4 of 6 www.remapcap.org
2.0 ACTION TAKEN
Participant Study Number
Serious Adverse Event Patient Initials
PLATFORM
(Censored at hospital discharge)
e.g. 18/JUL/2018 e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y
e.g. 18/JUL/2018
Date & time intervention started:
Date & time intervention stopped:
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
IF TEMPORARILY OR PERMANENTLY DISCONTINUED CORTICOSTEROID
Action taken: No action taken TN Temporarily discontinued intervention P Permanently discontinued intervention
D D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y :H H M M 24 hour clock
(check one)
Date & time intervention started:
Date & time intervention stopped:
IF TEMPORARILY OR PERMANENTLY DISCONTINUED MACROLIDE
Date & time intervention started:
Date & time intervention stopped:
IF TEMPORARILY OR PERMANENTLY DISCONTINUED ANTIBIOTIC
Date & time intervention started:
Date & time intervention stopped:
IF TEMPORARILY OR PERMANENTLY DISCONTINUED ANTIVIRALD D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
e.g. 18/JUL/2018 e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y :H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y :H H M M 24 hour clock
Date & time intervention started:
Date & time intervention stopped:
IF TEMPORARILY OR PERMANENTLY DISCONTINUED COVID‐19 IMMUNE MODULATION THERAPY
Date & time intervention started:
Date & time intervention stopped:
e.g. 18/JUL/2018 e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y :H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y :H H M M 24 hour clock
Date & time intervention started:
Date & time intervention stopped:
IF TEMPORARILY OR PERMANENTLY DISCONTINUED THERAPEUTIC ANTICOAGULATION
Date & time intervention started:
Date & time intervention stopped:
IF TEMPORARILY OR PERMANENTLY DISCONTINUED COVID‐19 ANTIVIRAL
e.g. 18/JUL/2018
IF TEMPORARILY OR PERMANENTLY DISCONTINUED IMMUNOGLOBULIN
UK REMAP‐CAP Case Report Form 12, V8 dated 20210226 Page 5 of 6 www.remapcap.org
Participant Study Number
Serious Adverse Event Patient Initials
e.g. 18/JUL/2018 e.g. 8:05pm = 20:05 hours
Treatment:
D D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y :H H M M 24 hour clock
2.0 ACTION TAKEN
Date & time intervention started:
Date & time intervention stopped:
IF TEMPORARILY OR PERMANENTLY DISCONTINUED VITAMN C
e.g. 18/JUL/2018 e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y :H H M M 24 hour clock
Date & time intervention started:
Date & time intervention stopped:
IF TEMPORARILY OR PERMANENTLY DISCONTINUED SIMVASTATIN
e.g. 18/JUL/2018 e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y :H H M M 24 hour clock
Date & time intervention started:
Date & time intervention stopped:
IF TEMPORARILY OR PERMANENTLY DISCONTINUED ANTIPLATELET
e.g. 18/JUL/2018 e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y
e.g. 18/JUL/2018
:H H M M 24 hour clock
e.g. 8:05pm = 20:05 hours
D D M M M Y Y Y Y :H H M M 24 hour clock
Date & time intervention started:
Date & time intervention stopped:
IF TEMPORARILY OR PERMANENTLY DISCONTINUED ACE2 RAS
UK REMAP‐CAP Case Report Form 12, V8 dated 20210226 Page 6 of 6 www.remapcap.org
Participant Study Number
Serious Adverse Event Patient Initials
Unresolved
Unknown/lost to follow‐up
Resolved
3.0 OUTCOME
Outcome:
Date of death:
Cause:
Location:
Autopsy:
D D M M M Y Y Y Y e.g. 18/JUL/2018
ICU
Ward
Other acute hospital
Report emailed:
Resolution date:
Specify:
(check one)
D D M M M Y Y Y Y e.g. 18/JUL/2018
Resolution date: D D M M M Y Y Y Y e.g. 18/JUL/2018
IF YES
Yes NY No
Yes NY No
Home
Nursing home or Long‐term care facility
IF RESOLVED WITH SEQUELAE
(Follow‐up SAE until resolved)
IF DEATH
IF RESOLVED
Resolved with sequelae
Death
Rehabilitation hospital
UK REMAP‐CAP Case Report Form 13, V8 dated 20210226 Page 1 of 12 www.remapcap.org
Patient was an inpatient in a healthcare facility within the last 30 days
Patient was not an adult in your jurisdiction
Community‐acquired pneumonia was not the primary diagnosis at randomisation
Death was deemed to be imminent and inevitable
Platform eligibility deviation:(check all that apply)
D D M M M Y Y Y Y e.g. 18/JUL/2018Deviation date:
Patient was not receiving the required organ support at randomisation
2.0 PROTOCOL DOMAIN‐SPECIFIC DEVIATION
D D M M M Y Y Y Y e.g. 18/JUL/2018Deviation date:
Reason:
Patient is a resident of a nursing home or long‐term care facility
Patient was hospitalised for 48 hours or longer prior to ICU admission
Patient was randomised in REMAP‐CAP in the previous 90 days
Deviation type:(check one)
Randomised but ineligible
A
R
Allocated study antibiotic not administered as per protocol
Received prohibited empiric antibiotic therapy R
Participant Study Number
Protocol Deviation Patient Initials
Specify:(check one)
Specify:(check one)
O Other, specify
Other, specify
What were the consequences or actions taken:
Patient had a known contraindication at the time of randomisation
Patient received IV antibiotics for more than 48 hours prior to randomisation
Other, specify
Patient was in ICU for more than 24 hours prior to randomisation
Standard empiric antibiotic therapy was known to be inappropriate at time of randomisation
Other, specify
Allocated study antibiotic not available
Allocated study antibiotic not prescribed
1.0 PROTOCOL DEVIATION
PLATFORM
ANTIBIOTIC DOMAIN
IF ALLOCATED STUDY ANTIBIOTIC NOT ADMINISTERED AS PER PROTOCOL
IF RANDOMISED BUT INELIGIBLE
(Censored at ICU discharge)
(Censored at ICU discharge)
Influenza was incorrectly entered as suspected or confirmed at time of randomisation
UK REMAP‐CAP Case Report Form 13, V8 dated 20210226 Page 2 of 12 www.remapcap.org
Reason:
What were the consequences or actions taken:
3.0 PROTOCOL DOMAIN‐SPECIFIC DEVIATION
Deviation type:
D D M M M Y Y Y Y e.g. 18/JUL/2018Deviation date:
R Received prohibited macrolide therapy
Randomised but ineligible
A
R
Incorrect duration of macrolide therapy
Participant Study Number
Protocol Deviation Patient Initials
Protocol macrolide not available
Other, specify
(check one)
Specify:(check one)
Specify:(check one)
Administration of prohibited antibiotic:
IF RECEIVED PROHIBITED EMPIRIC ANTIBIOTIC THERAPY
Reason:
What were the consequences or actions taken:
Allocated to extended duration and received less than 14 days (censored at ICU discharge)
Allocated to standard duration and received less than 3 days
Other, specify
Allocated to standard duration and received a macrolide on study day 6
Allocated to extended duration and received more than 14 days
O Other, specify
Specify:
(check one)
Other, specify
Patient had a known contraindication at the time of randomisation
Patient was not allocated to a beta‐lactam in the Antibiotic Domain
IF INCORRECT DURATION OF MACROLIDE THERAPY
IF RECEIVED PROHIBITED MACROLIDE THERAPY
MACROLIDE DURATION DOMAIN
IF RANDOMISED BUT INELIGIBLE
(Censored at ICU discharge)
UK REMAP‐CAP Case Report Form 13, V8 dated 20210226 Page 3 of 12 www.remapcap.org
Reason:
What were the consequences or actions taken:
D D M M M Y Y Y Y e.g. 18/JUL/2018Deviation date:
4.0 PROTOCOL DOMAIN‐SPECIFIC DEVIATION
Deviation type: Randomised but ineligible R
Intervention not administered as per protocolA
Participant Study Number
Protocol Deviation Patient Initials
Hydrocortisone not available
Incorrect dose administered
Specify:(check one)
Specify:(check one)
(check one)
IF RANDOMISED BUT INELIGIBLE
Patient had a known contraindication at the time of randomisation
Systemic corticosteroids required for a known indication other than CAP at time of randomisation
Other, specify
IF INTERVENTION NOT ADMINISTERED AS PER PROTOCOL
Incorrect frequency administered
Remaining course of hydrocortisone not prescribed at ICU discharge
Other, specify
CORTICOSTEROID DOMAIN
O Other, specify
Another corticosteroid was administeredC
(Censored at ICU discharge)
Received hydrocortisone when they should not have
Did not receive hydrocortisone when they should have
UK REMAP‐CAP Case Report Form 13, V8 dated 20210226 Page 4 of 12 www.remapcap.org
Reason:
What were the consequences or actions taken:
D D M M M Y Y Y Y e.g. 18/JUL/2018Deviation date:
4.0 PROTOCOL DOMAIN‐SPECIFIC DEVIATION
Deviation type: Randomised but ineligible R
Oseltamivir not administered as per protocolA
Participant Study Number
Protocol Deviation Patient Initials
Specify:(check one)
Specify:
(check one)
(check one)
IF RANDOMISED BUT INELIGIBLE
There was an intention to prescribe an antiviral active againts influenza other than Oseltamivir at the time of randomisation
Patient received two or more doses of Oseltamivir prior to randomisation
Patient had a known contraindication at the time of randomisation
IF OSELTAMIVIR NOT ADMINISTERED AS PER PROTOCOL
Interruption of more than 36 hours within the course (for 5‐day and 10‐day intervention)
Oseltamivir not available
Other, specify
ANTIVIRAL DOMAIN
O Other, specify
Administration of another antiviral active against influenzaC
Received Oseltamivir and another antiviral active against influenza
Did not receive Oseltamivir and received a different antiviral active against influenza
Specify:(check one)
Other, specify
IF ADMINISTRATION OF ANOTHER ANTIVIRAL ACTIVE AGAINST INFLUENZA
(Censored at ICU discharge)
Incorrect duration of therapy administered (premature cessation or continuation beyond the specified time)
Remaining course of Oseltamivir not prescribed at ICU discharge
Other, specify
UK REMAP‐CAP Case Report Form 13, V8 dated 20210226 Page 5 of 12 www.remapcap.org
Reason:
What were the consequences or actions taken:
D D M M M Y Y Y Y e.g. 18/JUL/2018Deviation date:
5.0 PROTOCOL DOMAIN‐SPECIFIC DEVIATION
Deviation type: Randomised but ineligible R
Intervention not administered as per protocolA
Participant Study Number
Protocol Deviation Patient Initials
Specify:(check one)
Specify:(check one)
(check one)
IF RANDOMISED BUT INELIGIBLE
Patient was participant in a trial of antivirals intended to be active against COVID‐19 where continuation of the study assignment was required
Microbiological testing for SARS‐CoV‐2 infection of upper or lower respiratory tract secretions not completed during hospital admission
Patient was receiving one of the COVID‐19 antivirals as a pre‐hospitalisation usual medication
No administration of an allocated antiviral
Other, specify
COVID‐19 ANTIVIRAL DOMAIN
O Other, specify
Received prohibited antiviral active against SARS‐CoV‐2C
Patient was administered a non‐assigned antiviral intended to be active against SARS‐CoV‐2Specify:(check one)
Other, specify
IF RECEIVED PROHIBITED ANTIVIRAL ACTIVE AGAINST SARS‐COV‐2
(Censored at ICU discharge)
Two or more sequential doses of lopinavir/ritonavir were missed
Other, specify
Two or more sequential doses of hydroxychloroquine were missed
At randomisation the patient had laboratory confirmed MERS‐CoV infection
Patient had a known contraindication at the time of randomisation
IF INTERVENTION NOT ADMINISTERED AS PER PROTOCOL
Patient had already received more than 36 hours of antiviral treatment for COVID‐19
Incorrect dose administered
UK REMAP‐CAP Case Report Form 13, V8 dated 20210226 Page 6 of 12 www.remapcap.org
Reason:
What were the consequences or actions taken:
D D M M M Y Y Y Y e.g. 18/JUL/2018Deviation date:
6.0 PROTOCOL DOMAIN‐SPECIFIC DEVIATION
Deviation type: Randomised but ineligible R
Intervention not administered as per protocolA
Participant Study Number
Protocol Deviation Patient Initials
Specify:(check one)
Specify:(check one)
(check one)
IF RANDOMISED BUT INELIGIBLE
Patient was receiving one of the agents included as interventions in this domain as a pre‐hospitalisation usual medication
Microbiological testing for SARS‐CoV‐2 infection of upper or lower respiratory tract secretions not completed during hospital admission
Patient had a known contraindication at the time of randomisation
No administration of an immune modulating agent intended to be active against SARS‐CoV‐2
Two or more sequential doses of Interferon beta‐1a were missed
Other, specify
COVID‐19 IMMUNE MODULATION THERAPY DOMAIN
O Other, specify
Received prohibited immune modulation agent for COVID‐19C
Patient was administered a non‐assigned immune modulating agent for COVID‐19Specify:(check one)
Other, specify
IF RECEIVED PROHIBITED IMMUNE MODULATION AGENT FOR COVID‐19
(Censored at ICU discharge)
Two or more sequential doses of tocilizumab were missed
Two or more sequential doses of sarilumab were missed
Other, specify
Two or more sequential doses of anakinra were missed
Patient had received one of the agents included as interventions in this domain during this hospitalisation
Patient had a known condition or was receiving treatment resulting in ongoing immune suppression at the time of randomisation
IF INTERVENTION NOT ADMINISTERED AS PER PROTOCOL
Patient was a participant in a trial of immune modulating drugs for COVID‐19 where continuation of study assignment was required
Incorrect dose administered
UK REMAP‐CAP Case Report Form 13, V8 dated 20210226 Page 7 of 12 www.remapcap.org
Reason:
What were the consequences or actions taken:
D D M M M Y Y Y Y e.g. 18/JUL/2018Deviation date:
7.0 PROTOCOL DOMAIN‐SPECIFIC DEVIATION
Deviation type: Randomised but ineligible R
Intervention not administered as per protocolA
Participant Study Number
Protocol Deviation Patient Initials
Specify:(check one)
Specify:(check one)
(check one)
IF RANDOMISED BUT INELIGIBLE
Patient was a participant in a trial of antibody therapy intended to be active against COVID‐19 where continuation of study assignment was required
Patient did not have confirmed COVID‐19 infection
No administration of convalescent plasma
Three or more units of convalescent plasma administered
Other, specify
COVID‐19 IMMUNOGLOBULIN DOMAIN
O Other, specify
Received prohibited antibody therapyC
Administered non‐assigned convalescent plasma for COVID‐19Specify:(check one)
Other, specify
IF RECEIVED PROHIBITED THERAPY
(Censored at ICU discharge)
Incorrect convalescent plasma administered
Allocated convalescent plasma not administered within 48 hours of randomisation
Other, specify
Two units of convalescent plasma administered within less than 12 hours of each other
Patient had a known contraindication at the time of randomisation
IF INTERVENTION NOT ADMINISTERED AS PER PROTOCOL
Patient had already received treatment with antibody therapy with the potential to be active against COVID‐19 prior to randomisation
Incorrect dose administered
UK REMAP‐CAP Case Report Form 13, V8 dated 20210226 Page 8 of 12 www.remapcap.org
Reason:
What were the consequences or actions taken:
D D M M M Y Y Y Y e.g. 18/JUL/2018Deviation date:
8.0 PROTOCOL DOMAIN‐SPECIFIC DEVIATION
Deviation type: Randomised but ineligible R
Intervention not administered as per protocolA
Participant Study Number
Protocol Deviation Patient Initials
Specify:(check one)
Specify:(check one)
(check one)
IF RANDOMISED BUT INELIGIBLE
Patient was a participant in a trial of therapeutic anticoagulation for COVID‐19 where continuation of study assignment was required
Microbiological testing for SARS‐CoV‐2 infection of upper or lower respiratory tract secretions not completed during hospital admission
No administration of therapeutic anticoagulation
Local standard pharmacological thromboprophylaxis not administered
Other, specify
COVID‐19 THERAPEUTIC ANTICOAGULATION DOMAIN
O Other, specify
Received prohibited therapeutic anticoagulationC
Administered non‐assigned therapeutic anticoagulationSpecify:(check one)
Other, specify
IF RECEIVED PROHIBITED THERAPY
(Censored at ICU discharge)
Other, specify
Patient had a known contraindication at the time of randomisation
IF INTERVENTION NOT ADMINISTERED AS PER PROTOCOL
Therapeutic anticoagulation already present at the time of randomisation
Therapeutic anticoagulation ceased for more than 24 hours
New agent commenced that is active against platelet formation
UK REMAP‐CAP Case Report Form 13, V8 dated 20210226 Page 9 of 12 www.remapcap.org
Reason:
What were the consequences or actions taken:
D D M M M Y Y Y Y e.g. 18/JUL/2018Deviation date:
9.0 PROTOCOL DOMAIN‐SPECIFIC DEVIATION
Deviation type: Randomised but ineligible R
Intervention not administered as per protocolA
Participant Study Number
Protocol Deviation Patient Initials
Specify:(check one)
Specify:(check one)
(check one)
IF RANDOMISED BUT INELIGIBLE
Patient had a known contraindication at the time of randomisation
Patient had received any IV vitamin C prior to randomisation during this hospitalisation
No administration of vitamin C
Missed two or more consecutive doses of vitamin C
Other, specify
VITAMIN C DOMAIN
O Other, specify
Received prohibited therapyC
Administered non‐assigned vitamin CSpecify:(check one)
Other, specify
IF RECEIVED PROHIBITED THERAPY
(Censored at ICU discharge)
Other, specify
IF INTERVENTION NOT ADMINISTERED AS PER PROTOCOL
Patient was a participant in a trial of vitamin C where continuation of study assignment was required
Incorrect dose administered
Missed more than a total of four doses of vitamin C
UK REMAP‐CAP Case Report Form 13, V8 dated 20210226 Page 10 of 12 www.remapcap.org
Reason:
What were the consequences or actions taken:
D D M M M Y Y Y Y e.g. 18/JUL/2018Deviation date:
10.0 PROTOCOL DOMAIN‐SPECIFIC DEVIATION
Deviation type: Randomised but ineligible R
Intervention not administered as per protocolA
Participant Study Number
Protocol Deviation Patient Initials
Specify:(check one)
Specify:(check one)
(check one)
IF RANDOMISED BUT INELIGIBLE
Creatinine more the 200 μmol/L (2.26 mg/dL) and not receiving renal replacement therapy
Known severe liver disease
No administration of allocated simvastatin
Missed two or more consecutive doses of simvastatin
Other, specify
COVID‐19 SIMVASTATIN DOMAIN
O Other, specify
Received prohibited therapyC
Patient was administered a non‐assigned statin for treatment of confirmed or suspected COVID‐19
Specify:(check one)
Other, specify
(Censored at ICU discharge)
Other, specify
IF INTERVENTION NOT ADMINISTERED AS PER PROTOCOL
Hypersensitivity to simvastatin
Incorrect dose administered
At the time of eligibility assessment was being treated with a medicine that could not be co‐administered with simvastatin
Patient had a known contraindication at the time of randomisation
At the time of eligibility assessment was being treated with a statin
Known to be pregnant or breastfeeding at the time of eligibility assessment
IF RECEIVED PROHIBITED THERAPY
Patient allocated to simvastatin intervention and received lopinavir/ritonavir
UK REMAP‐CAP Case Report Form 13, V8 dated 20210226 Page 11 of 12 www.remapcap.org
Reason:
What were the consequences or actions taken:
D D M M M Y Y Y Y e.g. 18/JUL/2018Deviation date:
11.0 PROTOCOL DOMAIN‐SPECIFIC DEVIATION
Deviation type: Randomised but ineligible R
Intervention not administered as per protocolA
Participant Study Number
Protocol Deviation Patient Initials
Specify:(check one)
Specify:(check one)
(check one)
IF RANDOMISED BUT INELIGIBLE
Patient was a participant in a trial of antiplatelet therapy for COVID‐19 where continuation of study assignment was required
Microbiological testing for SARS‐CoV‐2 infection of upper or lower respiratory tract secretions not completed during hospital admission
No administration of antiplatelet therapy
Other, specify
COVID‐19 ANTIPLATELET DOMAIN
O Other, specify
Received prohibited antiplatelet therapyC
Administered non‐assigned antiplatelet therapySpecify:(check one)
Other, specify
(Censored at ICU discharge)
Other, specify
Patient had a known contraindication at the time of randomisation (including clinical or laboratory bleeding risk, Creatinine Clearance < 30 ml/min, or receiving renal replacement therapy or ECMO)
IF INTERVENTION NOT ADMINISTERED AS PER PROTOCOL
Antiplatelet or NSAID therapy already commenced at the time of randomisation
Incorrect dose administered
Incorrect duration of antiplatelet therapy administered
Received concomitant lopinavir/ritonavir with ticagrelor or clopidogrel
IF RECEIVED PROHIBITED THERAPY
UK REMAP‐CAP Case Report Form 13, V8 dated 20210226 Page 12 of 12 www.remapcap.org
Reason:
What were the consequences or actions taken:
D D M M M Y Y Y Y e.g. 18/JUL/2018Deviation date:
12.0 PROTOCOL DOMAIN‐SPECIFIC DEVIATION
Deviation type: Randomised but ineligible R
Intervention not administered as per protocolA
Participant Study Number
Protocol Deviation Patient Initials
Specify:(check one)
Specify:(check one)
(check one)
IF RANDOMISED BUT INELIGIBLE
Patient was receiving one of the ACE2 RAS agents included as interventions in this domain as a pre‐hospitalisation usual medication
Patient was a participant in a trial of ACE2 RAS agent for COVID‐19 where continuation of study assignment was required
Patient had an alanine aminotranferase or aspartate aminotransferase more than 5 times the upper limit of normal and received ARB + DMX‐200
Other, specify
COVID‐19 ACE2 RAS DOMAIN
O Other, specify
Received prohibited renin‐angiotensin modulation therapyC
Administered non‐assigned renin‐angiotensin modulation therapySpecify:(check one)
Other, specify
(Censored at ICU discharge)
Other, specify
Known hypersensitivity to ACEi or ARB, including angioedema
IF INTERVENTION NOT ADMINISTERED AS PER PROTOCOL
Patient had known viral hepatitis and received ARB + DMX‐200
Patient had hypersensitivity to repagermanium and received ARB + DMX‐200
IF RECEIVED PROHIBITED THERAPY
Patient had a known contraindication at the time of randomisation
Known severe liver disease at the time of randomisation
Known severe renal artery stenosis at the time of randomisation
Renal impairment with creatinine clearance < 30 ml/min or receiving renal replacement therapy
UK REMAP‐CAP Case Report Form 2, V8 dated 20210226 Page 1 of 2 www.remapcap.org
Participant Study Number
Supplementary Baseline Patient Initials
PLATFORM
ICU admission source: Emergency department – same hospital
ICU/HDU – same hospital
Emergency department – other hospital
ICU/HDU – other hospital
Ward – other hospitalWard – same hospital
(check one)
1.0 ICU ADMISSION SOURCE (This hospital admission)
Patient location at baseline: Physical ICU
Re‐purposed ICU
Ward
ED
2.0 APACHE II
APACHE II acute physiology score: (0‐60) APS
3.0 INTERVENTIONS & PHYSIOLOGY AT BASELINE (This hospital admission, closest
prior to randomisation)
(24 hours prior to randomisation)
Creatinine: µmol/L
Platelet count: Cells x 109 /L
N Not recorded
N Not recorded
Bilirubin: N Not recorded
Lactate: mmol/L.
FiO2 at time of ABG: e.g. room air = 0.21.
N Not recorded
Corresponding PaO2: mmHg kPa.
Corresponding PEEP: cmH2O.
N Not recorded
N Not recorded
Glasgow Coma Scale Score:
µmol/L mg/dL.
mg/dL
Cells/mm3
N Not recorded
mg/dL.
Renal replacement therapy: Yes NY No
Yes NY NoExtracorporeal gas exchange:
Received:Extracorporeal membrane oxygenation (ECMO)
Extracorporeal carbon dioxide removal (ECCO2R)
(check all that apply)
Skip to section 7 (if applicable)
IF YES
Extended Cardiovascular SOFA score:(check one)
0 1 2 3 4 4+
(check one)
P Patient receiving APRV
UK REMAP‐CAP Case Report Form 2, V8 dated 20210226 Page 2 of 2 www.remapcap.org
Participant Study Number
Supplementary Baseline Patient Initials
4.0 PHYSIOLOGY AT BASELINE (PANDEMIC ONLY) (Closest prior to randomisation, within 8 hours of randomisation or two hours after randomisation)
Ferritin: N Not recorded
D‐dimer:
C‐Reactive Protein:
Neutrophil count:
Lymphocyte count: Cells x 109 /L.
Cells x 109 /L.
mg/L or µg/mL
µg/L or ng/mL
N Not recorded
N Not recorded
N Not recorded
N Not recorded
µg/L or ng/mL
Troponin:
ng/L or pg/mL N Not recorded
µg/mL or mg/L.
mg/dL.
Cells/mm3
Cells/mm3
ng/mL
Test
(check one)
High sensitivity Troponin T Troponin T
Troponin I
Result .
N Not recorded
ng/mL.ng/L or pg/mLUpper reference limit (99th percentile)
.
High sensitivity Troponin I
INR or Prothrombin ratio (PR): N Not recorded
Fibrinogen: g/L N Not recorded
.
mg/dL
(INR: preferred; PR: accepted)
.
Temperature: N Not recorded
Heart rate:
Systolic blood pressure:
Respiratory rate:
Bicarbonate: mEq/L.
mmHg
N Not recorded
N Not recorded
N Not recorded
N Not recorded
oC.oF.
bpm
Albumin: g/dL. N Not recorded
mmol/L.
bpm
. e.g. 0.21
D D M M M Y Y Y Y e.g. 18/JUL/2018
1.0 STUDY DAY
Study day
2.0 DAILY TREATMENTS
Renal replacement therapy:
Extended Cardiovascular SOFA score:
YesY
Date
Study days (01‐28)
Corresponding PaO2:
FiO2 associated with lowest P/F ratio:
kPa.
Airway:
High flow nasal prong oxygen therapy:
Non invasive ventilation:
TEO Maintaining own Tracheostomy Endotracheal tube
Hours of invasive mechanical ventilation: hours (0‐24)
N Not recordedmmHg
N No
Corresponding PEEP: cmH2O
Participant Study Number
Supplementary Daily Patient Initials
Yes NY NoExtracorporeal gas exchange:
Received: Extracorporeal membrane oxygenation (ECMO)
Extracorporeal carbon dioxide removal (ECCO2R)
IF YES
(check all that apply)
(check one)
IF MAINTAINING OWN
PLATFORM
0 1 2 3 4(check one)
Patient location on study day Physical ICU Re‐purposed ICU
Patient in ICU during this day Yes NY No
Collect daily data for the duration of the ICU admission (censored at study day 28). If the patient is allocated to fixed course steroid, collect corticosteroid administration up until D9 while on ward.
Yes NY
Yes NY No
No
(Supplementary to FORM 4 Daily)
UK REMAP‐CAP Case Report Form 4, V8 dated 20210226 Page 1 of 3 www.remapcap.org
IF ETT or TT
P Patient receiving APRV
4+
CORTICOSTEROID DOMAIN
Participant Study Number
Supplementary Daily Patient Initials
4.0 HYDROCORTISONE ADMINISTRATION
Was another corticosteroid administered:
Name of corticosteroid:
Total daily dose:
Yes NY No
mg
IF YES
Study day: (01‐28)
Hydrocortisone (oral)
Betamethasone
Methylprednisolone
Prednisolone
Prednisone
Triamcinolone
DexamethasoneHydrocortisone (IV)
Yes NY NoWas this dose administered for the patient’s initial episode of CAP or its complications:
What was the corticosteroid administered for:
IF NO
Was another corticosteroid administered:
Name of corticosteroid:
Total daily dose:
Yes NY No
mg
IF YES
Study day: (01‐28)
Hydrocortisone (oral)
Betamethasone
Methylprednisolone
Prednisolone
Prednisone
Triamcinolone
DexamethasoneHydrocortisone (IV)
Yes NY NoWas this dose administered for the patient’s initial episode of CAP or its complications:
What was the corticosteroid administered for:
IF NO
3.0 CORTICOSTEROID ADMINISTRATION
Was a corticosteroid administered on this study day:
Name of corticosteroid
Total daily dose:
Yes NY No
mg
Hydrocortisone (oral)
Betamethasone
Methylprednisolone
Prednisolone
Prednisone
Triamcinolone
Dexamethasone
Yes NY No
Was this dose administered for the patient’s initial episode of CAP or its complications:IF NO
Hydrocortisone (IV)
IF YES
Skip this section
UK REMAP‐CAP Case Report Form 4, V8 dated 20210226 Page 2 of 3 www.remapcap.org
Participant Study Number
Supplementary Daily Patient Initials
Was another corticosteroid administered:
Name of corticosteroid:
Total daily dose:
Yes NY No
mg
IF YES
Study day: (01‐28)
Hydrocortisone (oral)
Betamethasone
Methylprednisolone
Prednisolone
Prednisone
Triamcinolone
DexamethasoneHydrocortisone (IV)
Yes NY NoWas this dose administered for the patient’s initial episode of CAP or its complications:
What was the corticosteroid administered for:
IF NO
Was another corticosteroid administered:
Name of corticosteroid:
Total daily dose:
Yes NY No
mg
IF YES
Study day: (01‐28)
Hydrocortisone (oral)
Betamethasone
Methylprednisolone
Prednisolone
Prednisone
Triamcinolone
DexamethasoneHydrocortisone (IV)
Yes NY NoWas this dose administered for the patient’s initial episode of CAP or its complications:
What was the corticosteroid administered for:
IF NO
Was another corticosteroid administered:
Name of corticosteroid:
Total daily dose:
Yes NY No
mg
IF YES
Study day: (01‐28)
Hydrocortisone (oral)
Betamethasone
Methylprednisolone
Prednisolone
Prednisone
Triamcinolone
DexamethasoneHydrocortisone (IV)
Yes NY NoWas this dose administered for the patient’s initial episode of CAP or its complications:
What was the corticosteroid administered for:
IF NO
UK REMAP‐CAP Case Report Form 4, V8 dated 20210226 Page 3 of 3 www.remapcap.org
2.0 ICU READMISSION
PLATFORM
Participant Study Number
Supplementary Discharge Patient Initials
(Supplementary to FORM 6 Discharge)
3rd ICU readmission: Yes NY No Skip to section 3
ICU readmission date & time:
ICU discharge date & time:
IF YES D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
*Date and time of first organ support in ICU this readmission:
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
4th ICU readmission: Yes NY No Skip to section 3
ICU readmission date & time:
ICU discharge date & time:
IF YESD D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours
*Date and time of first organ support in ICU this readmission:
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
*Date and time of last organ support in ICU this readmission:
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
*Date and time of last organ support in ICU this readmission:
D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018
,e.g 8:05pm = 20:05 hours
Did the patient receive organ support during this ICU admission NY No
IF YES
Did the patient receive organ support during this ICU admission Yes NY No
Yes
IF YES
UK REMAP‐CAP Case Report Form 6, V8 dated 20210226 Page 1 of 2 www.remapcap.org
* = Only required for Pandemic Infection Suspected or Confirmed Patients
If a patient is randomised into the Therapeutic Anticoagulation and Immunoglobulin domains at two different timepoints multiple peak troponin tests, major bleeding episodes and RBC tranfusion episodes can be added to the eCRF.
Participant Study Number
Supplementary Discharge Patient Initials
THERAPEUTIC ANTICOAGULATION / ANTIPLATELET/ IMMUNOGLOBULIN 9.0 DOMAIN‐SPECIFIC ENDPOINTS (Censored at hospital discharge)
2nd Peak troponin‐test method:
ng/L or pg/mL N Not recordedng/mL
Test:(check one)
High sensitivity Troponin T Troponin T
Troponin I
Result: .
N Not recorded
ng/mL.ng/L or pg/mLUpper reference limit (99th percentile):
High sensitivity Troponin I
between last randomisation and hospital discharge
UK REMAP‐CAP Case Report Form 6, V8 dated 20210226 Page 2 of 2 www.remapcap.org
2nd Number of units of red blood cells transfused:between first randomisation and 15 days after last randomisation
Yes N No2nd Major bleeding: Y
IF YES
Major bleeding description of event(s): ……………………………………………………………………………………………………...
………………………………………………………………………………………….…………………………………………………………….……………
……………….………………………………………………………………………………………….………………………………………………………..
…………………………….………………………………………………………………………………………….…………………………………………..
Major bleeding event date & time: D D M M M Y Y Y Y H 24 hour clock: M MH
e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hoursbetween first randomisation and 15 days
after last randomisation
Which one or more of these criteria were met:
Fatal bleeding
Blood loss causing a fall in haemoglobin ≥ 2g/dL
Symptomatic or clinically manifest bleeding in a critical area or organ
(check all that apply)
Blood loss leading to transfusion of ≥ 2 units of red cells or whole blood
Only required for patients randomised to V3 anticoagulation domain (and antiplatelet going forward)