case report form - icnarc

UK REMAP‐CAP Case Report Form V8, dated 20210226 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)


X Y

P H

L S

B R


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


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:


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



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)




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.




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)


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



On specimens collected within 72 hours of hospital admission (check all that apply)

Chlamydophila pneumoniae

Mycoplasma pneumoniae

Respiratory Syncytial Virus

Coronavirus


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


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


2.0 POSITIVE BLOOD CULTURE





Acinetobacter spp

Escherichia coli

Haemophilus influenzae

Burkholderia pseudomallei

Klebsiella spp

Pseudomonas aeruginosa

Staphylococcus aureus

Moraxella catarrhalis


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 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:




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




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



Klebsiella spp






Coagulase negative staphylococci

Corynebacterium, Bacillus spp, Micrococcus, Propionibacterium

Other, specify




On specimens collected within 7 days of hospital admission Y N

Skip to PCR performed on pleural fluid


Yes No









IF YES





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 YES







IF E COLI










On specimens collected within 7 days of hospital admission

Positive lower respiratory tract or lung tissue specimen:

4.0 IMMUNOCOMPROMISED PATIENTS


Y Yes N No N Not tested


Aspergillus

Mucormycosis species

Nocardia species

Cryptococcus species

Non‐TB mycobacteria

Pneumocystis

Tuberculosis

Varicella zoster virus

None of the above




(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


N Not tested

Which organisms were detected: (check all that apply)

IF YES

Acinetobacter spp

Escherichia coli



Klebsiella spp







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



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


Daily Patient Initials

Yes NY No

IF ETT or TT



Extracorporeal carbon dioxide removal (ECCO2R)

IF YES


(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




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


GLOBAL REMAP‐CAP Case Report Form V2.1 dated 20190129 Page 1 of 2 www.remapcap.org



Date

Corresponding PaO2:

FiO2 associated with lowest P:F ratio:

Airway:


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.



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 Y Y Y Y

H

e.g. 01/JUN/2018

e.g. 8:05pm = 20:05hours


, mg

g.

I Intravenous

E Enteral


D D M M M Y Y Y Y

H

e.g. 01/JUN/2018

e.g. 8:05pm = 20:05hours


,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


D D M M M YY Y Y



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


,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


,

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




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


N

N

D D M M M Y Y Y Y mg4 Y Yes N No mg



N

N




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 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




Form 5

PLATFORM



Date & time first dose administered:Agent name:


D D M M M Y Y Y Y

H

e.g. 01/JUN/2018

e.g. 8:05pm = 20:05hours


, 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:


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


,

4.0 IMMUNE MODULATION ADMINISTRATION (New course censored at study day 14 (inclusive))

I Inhaled

ISubcutaneous or intra‐muscular

D


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)




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


, ml

Volume transfused:


mlD D M M M Y Y Y Y

H

e.g. 01/JUN/2018

e.g. 8:05pm = 20:05hours


,

Pandemic convalescent plasma

Intravenous immunoglobulin (non‐pandemic specific)

5.0 IMMUNOMODULATORY AND ANTIBODY ADMINISTRATION (New course censored at study day 14 (inclusive))

D


D

(Check one)

H

e.g. 8:05pm = 20:05hours


H

e.g. 8:05pm = 20:05hours


,

,

Donation number:(Textbox)


mlD D M M M Y Y Y Y

H

e.g. 01/JUN/2018

e.g. 8:05pm = 20:05hours


, D

H

e.g. 8:05pm = 20:05hours


,


mlD D M M M Y Y Y Y

H

e.g. 01/JUN/2018

e.g. 8:05pm = 20:05hours


, D

H

e.g. 8:05pm = 20:05hours


,


mlD D M M M Y Y Y Y

H

e.g. 01/JUN/2018

e.g. 8:05pm = 20:05hours


, D

H

e.g. 8:05pm = 20:05hours


,

Pandemic hyperimmune globulin














D D M M M YY Y Y





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


D D M M M Y Y Y Y

H

e.g. 01/JUN/2018

e.g. 8:05pm = 20:05hours


,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)


D D M M M YY Y Y



Date infusion ceased:Initial prescribed frequency:


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


,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 Y Y Y Y

H

e.g. 01/JUN/2018

e.g. 8:05pm = 20:05hours


,mg/hr

mcg/hr

I Intravenous

HInto haemofilter

Continuous infusion Unfractionated heparin

Argatroban

Bilvalirudin

Abciximab

Eptifibatide

TriofibanIU/hr


D D M M M Y Y Y Y

H

e.g. 01/JUN/2018

e.g. 8:05pm = 20:05hours


,

mcg/hr

I Intravenous

HInto haemofilter


Argatroban

Bilvalirudin

Abciximab

Eptifibatide

TriofibanIU/hr

mg/hr


D D M M M Y Y Y Y

H

e.g. 01/JUN/2018

e.g. 8:05pm = 20:05hours


,

mcg/hr

I Intravenous

HInto haemofilter


Argatroban

Bilvalirudin

Abciximab

Eptifibatide

TriofibanIU/hr

mg/hr

(Check one)


D D M M M YY Y Y






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


D D M M M Y Y Y Y

H

e.g. 01/JUN/2018

e.g. 8:05pm = 20:05hours


,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:


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


,

Thiamine

Vitamin C

Thiamine

D

(Check one)


D D M M M YY Y Y



Date last dose administered:Prescribed daily frequency:



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


,mg E Enteral Daily

8 hourly

12 hourly

6 hourly

4 hourly

Form 5

Simvastatin

Prescribed dose:


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


,

Atorvastatin

D

Rosuvastatin

Pravastatin

Lovastatin

Simvastatin

Atorvastatin

Rosuvastatin

Pravastatin

Lovastatin


D D M M M YY Y Y



Date last dose administered:Prescribed daily frequency:



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


,mg Daily

8 hourly

12 hourly

6 hourly

4 hourly

Form 5

Hydrocortisone

Prescribed dose:


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


,

Betamethasone

D

Dexamethasone

Methylprednisolone

Prednisolone

Prednisone

Triamcinolone

Hydrocortisone

Betamethasone

Dexamethasone

Methylprednisolone

Prednisolone

Prednisone

Triamcinolone

I Intravenous

E Enteral

I Intravenous

E Enteral

(Check one)


D M M M YY Y Y



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


Form 5

Losartan

Olmesartan


D D M M M Y Y Y Y H

e.g. 01/JUN/2018 e.g. 8:05pm = 20:05hours


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 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




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



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





Other

…………………………………..………Specify:

…………………………………..………..………..……………………………………..………..……...……..…

Hyperkalemia





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.


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:



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


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




e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours


e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours

*Date and time of first organ support in ICU this readmission:


e.g. 01/JUN/2018

,e.g 8:05pm = 20:05 hours

*Date and time of last organ support in ICU this readmission:


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


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


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


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:



e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours


e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours



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




e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours


e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours



e.g. 01/JUN/2018

,e.g 8:05pm = 20:05 hours


Patient Initials

Form Discharge

PLATFORM



e.g. 01/JUN/2018

,e.g 8:05pm = 20:05 hours

UUnable to ascertain







e.g. 01/JUN/2018

,e.g 8:05pm = 20:05 hours


IF YESU

Unable 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)


IF YES


IF YES

Status:




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:


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: ……………….…………………………




N Not enrolled in ATTACC

N Not enrolled in ASCOT

N Not enrolled in LOVIT



Patient Initials

Form Discharge

7.0 DOMAIN SECONDARY OUTCOMES

MACROLIDE DURATION DOMAIN + COVID‐19 ANTIVIRAL DOMAIN


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


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:


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:


Vancomycin‐resistant Enterococcus isolated or detected: Yes NY No

Date first positive specimen collected:


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



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



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:


Test:(check one)


Troponin I

Result: .

N Not recorded

ng/mL.ng/L or pg/mLUpper reference limit (99th percentile):


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


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)



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


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


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


COVID‐19 without venous or arterial thromboembolism

RRT

Other

IF OTHER

Specify: ……………………………………..…………………………………………………




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 recorded

N Not recorded


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

of 4 www.remapcap.orgUK REMAP‐CAP Case Report Form 7, V8 dated 20210226

1.0 AGREEMENT EVENT


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


1.0 AGREEMENT EVENT









(check one)

(check one)

N Not applicable

N Not applicable

N Not applicable


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




(check one)

(check one)

N Not applicable

N Not applicable

N Not applicable



(check one)

(check one)

N Not applicable

Permission to contact the patient to complete the follow‐up questionnaires:


(check one)

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(check one)


(check one)

2.0 PATIENT AGREEMENT EVENT





N NoY YesWas the patient capable of providing agreement during this hospital admission:

Was the patient approached to provide agreement:

Reason not approached:





(check one)

(check one)

(check one)

N Not applicable

N Not applicable

N Not applicable


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)

N Not applicable

Permission to contact the patient to complete the follow‐up questionnaires:


(check one)

N Not applicable



N NoY Yes

IF NO

IF YES




(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




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


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





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)




END OF CONSENT CRF

Immunoglobulin Domain Outcome:

Therapeutic Anticoagulation Domain Outcome:

Vitamin C Domain Outcome:

(check one)

(check one)

(check one)




Simvastatin Domain Outcome:(check one)


Antiplatelet Domain Outcome:(check one)


ACE2 RAS Domain Outcome:(check one)




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


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:





(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


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



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:



(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


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:


S Same date as Assessment date



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


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



(check one)

(check one)

Health today scale


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



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)


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



(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


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


Serious Adverse Event Patient Initials

PLATFORM



(IF ANTIBIOTIC DOMAIN)













(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











PLATFORM


(IF COVID‐19 ANTIVIRAL DOMAIN)







(IF COVID‐19 IMMUNE MODULATION THERAPY DOMAIN)







(IF IMMUNOGLOBULIN DOMAIN)







(IF THERAPEUTIC ANTICOAGULATION DOMAIN)







(IF VITAMIN C DOMAIN)







(IF ANTIVIRAL DOMAIN)


D D M M M Y Y Y Y e.g. 18/JUL/2018Onset date:










PLATFORM


(IF ANTIPLATELET DOMAIN)







(IF SIMVASTATIN DOMAIN)







(IF ACE2 RAS DOMAIN)


2.0 ACTION TAKEN



PLATFORM


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


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:


e.g. 8:05pm = 20:05 hours

D D M M M Y Y Y Y

e.g. 18/JUL/2018


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


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)



IF TEMPORARILY OR PERMANENTLY DISCONTINUED MACROLIDE



IF TEMPORARILY OR PERMANENTLY DISCONTINUED ANTIBIOTIC



IF TEMPORARILY OR PERMANENTLY DISCONTINUED ANTIVIRALD D M M M Y Y Y Y

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


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


e.g. 8:05pm = 20:05 hours


e.g. 8:05pm = 20:05 hours

D D M M M Y Y Y Y

e.g. 18/JUL/2018


e.g. 8:05pm = 20:05 hours




IF TEMPORARILY OR PERMANENTLY DISCONTINUED COVID‐19 IMMUNE MODULATION THERAPY



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


e.g. 8:05pm = 20:05 hours


e.g. 8:05pm = 20:05 hours

D D M M M Y Y Y Y

e.g. 18/JUL/2018


e.g. 8:05pm = 20:05 hours




IF TEMPORARILY OR PERMANENTLY DISCONTINUED THERAPEUTIC ANTICOAGULATION



IF TEMPORARILY OR PERMANENTLY DISCONTINUED COVID‐19 ANTIVIRAL

e.g. 18/JUL/2018

IF TEMPORARILY OR PERMANENTLY DISCONTINUED IMMUNOGLOBULIN




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


e.g. 8:05pm = 20:05 hours


2.0 ACTION TAKEN



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


e.g. 8:05pm = 20:05 hours




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


e.g. 8:05pm = 20:05 hours




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


e.g. 8:05pm = 20:05 hours




IF TEMPORARILY OR PERMANENTLY DISCONTINUED ACE2 RAS




Unresolved

Unknown/lost to follow‐up

Resolved

3.0 OUTCOME

Outcome:

Date of death:

Cause:

Location:

Autopsy:


ICU

Ward

Other acute hospital

Report emailed:

Resolution date:

Specify:

(check one)


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


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


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


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)


Influenza was incorrectly entered as suspected or confirmed at time of randomisation


Reason:



Deviation type:


R Received prohibited macrolide therapy

Randomised but ineligible

A

R

Incorrect duration of macrolide therapy



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:


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 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




Reason:




Deviation type: Randomised but ineligible R

Intervention not administered as per protocolA



Hydrocortisone not available

Incorrect dose administered

Specify:(check one)

Specify:(check one)

(check one)



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


O Other, specify

Another corticosteroid was administeredC


Received hydrocortisone when they should not have

Did not receive hydrocortisone when they should have


Reason:





Oseltamivir not administered as per protocolA



Specify:(check one)

Specify:

(check one)

(check one)


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


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


Incorrect duration of therapy administered (premature cessation or continuation beyond the specified time)

Remaining course of Oseltamivir not prescribed at ICU discharge

Other, specify


Reason:








Specify:(check one)

Specify:(check one)

(check one)


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


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 already received more than 36 hours of antiviral treatment for COVID‐19



Reason:








Specify:(check one)

Specify:(check one)

(check one)


Patient was receiving one of the agents included as interventions in this domain as a pre‐hospitalisation usual medication



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


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


Patient was a participant in a trial of immune modulating drugs for COVID‐19 where continuation of study assignment was required



Reason:








Specify:(check one)

Specify:(check one)

(check one)


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


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 already received treatment with antibody therapy with the potential to be active against COVID‐19 prior to randomisation



Reason:








Specify:(check one)

Specify:(check one)

(check one)


Patient was a participant in a trial of therapeutic anticoagulation for COVID‐19 where continuation of study assignment was required


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



Other, specify



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


Reason:








Specify:(check one)

Specify:(check one)

(check one)



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



Other, specify


Patient was a participant in a trial of vitamin C where continuation of study assignment was required


Missed more than a total of four doses of vitamin C


Reason:








Specify:(check one)

Specify:(check one)

(check one)


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


Other, specify


Hypersensitivity to simvastatin


At the time of eligibility assessment was being treated with a medicine that could not be co‐administered with simvastatin


At the time of eligibility assessment was being treated with a statin

Known to be pregnant or breastfeeding at the time of eligibility assessment


Patient allocated to simvastatin intervention and received lopinavir/ritonavir


Reason:








Specify:(check one)

Specify:(check one)

(check one)


Patient was a participant in a trial of antiplatelet therapy for COVID‐19 where continuation of study assignment was required


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


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)


Antiplatelet or NSAID therapy already commenced at the time of randomisation


Incorrect duration of antiplatelet therapy administered

Received concomitant lopinavir/ritonavir with ticagrelor or clopidogrel



Reason:








Specify:(check one)

Specify:(check one)

(check one)


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


Other, specify

Known hypersensitivity to ACEi or ARB, including angioedema


Patient had known viral hepatitis and received ARB + DMX‐200

Patient had hypersensitivity to repagermanium and received ARB + DMX‐200



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



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


Received:Extracorporeal membrane oxygenation (ECMO)




IF YES

Extended Cardiovascular SOFA score:(check one)

0 1 2 3 4 4+

(check one)




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)


Troponin I

Result .

N Not recorded

ng/mL.ng/L or pg/mLUpper reference limit (99th percentile)

.


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


1.0 STUDY DAY

Study day




YesY

Date

Study days (01‐28)

Corresponding PaO2:

FiO2 associated with lowest P/F ratio:

kPa.

Airway:


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


Supplementary Daily Patient Initials




IF YES


(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)


IF ETT or TT


4+




4.0 HYDROCORTISONE ADMINISTRATION

Was another corticosteroid administered:

Name of corticosteroid:

Total daily dose:

Yes NY No

mg

IF YES

Study day: (01‐28)


Betamethasone

Methylprednisolone

Prednisolone

Prednisone

Triamcinolone

DexamethasoneHydrocortisone (IV)

Yes NY NoWas this dose administered for the patient’s initial episode of CAP or its complications:


IF NO



Total daily dose:

Yes NY No

mg

IF YES



Betamethasone

Methylprednisolone

Prednisolone

Prednisone

Triamcinolone




IF NO

3.0 CORTICOSTEROID ADMINISTRATION

Was a corticosteroid administered on this study day:

Name of corticosteroid

Total daily dose:

Yes NY No

mg


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






Total daily dose:

Yes NY No

mg

IF YES



Betamethasone

Methylprednisolone

Prednisolone

Prednisone

Triamcinolone




IF NO



Total daily dose:

Yes NY No

mg

IF YES



Betamethasone

Methylprednisolone

Prednisolone

Prednisone

Triamcinolone




IF NO



Total daily dose:

Yes NY No

mg

IF YES



Betamethasone

Methylprednisolone

Prednisolone

Prednisone

Triamcinolone




IF NO


2.0 ICU READMISSION

PLATFORM


Supplementary Discharge Patient Initials

(Supplementary to FORM 6 Discharge)

3rd ICU readmission: Yes NY No Skip to section 3



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


e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours



e.g. 01/JUN/2018

,e.g 8:05pm = 20:05 hours

4th ICU readmission: Yes NY No Skip to section 3




e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours


e.g. 01/JUN/2018 ,e.g 8:05pm = 20:05 hours



e.g. 01/JUN/2018

,e.g 8:05pm = 20:05 hours



e.g. 01/JUN/2018

,e.g 8:05pm = 20:05 hours



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


Yes

IF YES



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.


Supplementary Discharge Patient Initials

THERAPEUTIC ANTICOAGULATION / ANTIPLATELET/ IMMUNOGLOBULIN 9.0 DOMAIN‐SPECIFIC ENDPOINTS (Censored at hospital discharge)

2nd Peak troponin‐test method:


Test:(check one)


Troponin I

Result: .

N Not recorded

ng/mL.ng/L or pg/mLUpper reference limit (99th percentile):


between last randomisation and hospital discharge


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


Blood loss leading to transfusion of ≥ 2 units of red cells or whole blood


case report form - icnarc

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