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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02735707




Registration number
NCT02735707
Ethics application status
Date submitted
11/12/2015
Date registered
13/04/2016

Titles & IDs
Public title
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Scientific title
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Secondary ID [1] 0 0
2015-002340-14
Secondary ID [2] 0 0
U1111-1189-1653
Universal Trial Number (UTN)
Trial acronym
REMAP-CAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Community-acquired Pneumonia, Influenza, COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ceftriaxone
Treatment: Drugs - Moxifloxacin or Levofloxacin
Treatment: Drugs - Piperacillin-tazobactam
Treatment: Drugs - Ceftaroline
Treatment: Drugs - Amoxicillin-clavulanate
Treatment: Drugs - Standard course macrolide
Treatment: Drugs - Extended course macrolide
Other interventions - No systemic corticosteroid
Treatment: Drugs - Fixed-duration Hydrocortisone
Treatment: Drugs - Shock-dependent hydrocortisone
Treatment: Drugs - Fixed-duration higher dose Hydrocortisone
Other interventions - No antiviral agent for influenza
Treatment: Drugs - Five-days oseltamivir
Treatment: Drugs - Ten-days oseltamivir
Other interventions - No antiviral agent for COVID-19
Treatment: Drugs - Lopinavir / Ritonavir
Treatment: Drugs - Hydroxychloroquine
Treatment: Drugs - Hydroxychloroquine + lopinavir/ritonavir
Treatment: Drugs - Ivermectin
Other interventions - No immune modulation for COVID-19
Treatment: Drugs - Interferon beta-1a
Treatment: Drugs - Anakinra
Treatment: Drugs - Tocilizumab
Treatment: Drugs - Sarilumab
Treatment: Drugs - Local standard venous thromboprophylaxis
Treatment: Drugs - Therapeutic dose anticoagulation
Treatment: Drugs - Conventional low dose thromboprophylaxis
Treatment: Drugs - Intermediate dose thromboprophylaxis
Treatment: Drugs - Continuation of therapeutic dose anticoagulation
Other interventions - No immunoglobulin
Treatment: Other - Convalescent plasma
Treatment: Other - Delayed administration of convalescent plasma
Other interventions - No vitamin C
Treatment: Drugs - Vitamin C
Other interventions - No antiplatelet
Treatment: Drugs - Aspirin
Treatment: Drugs - P2Y12 inhibitor
Other interventions - No simvastatin
Treatment: Drugs - Simvastatin
Treatment: Drugs - Eritoran
Treatment: Drugs - Apremilast
Treatment: Surgery - Clinician-preferred mechanical ventilation strategy
Treatment: Surgery - Protocolised mechanical ventilation strategy
Other interventions - No renin-angiotensin system inhibitor
Treatment: Drugs - Angiotensin converting enzyme inhibitor
Treatment: Drugs - Angiotensin Receptor Blockers
Treatment: Drugs - ARB + DMX-200
Other interventions - No cysteamine
Treatment: Drugs - Cysteamine
Treatment: Drugs - Fixed-duration dexamethasone
Treatment: Drugs - Baloxavir Marboxil
Treatment: Drugs - Five-days oseltamivir + baloxavir marboxil
Treatment: Drugs - Ten-days oseltamivir + baloxavir marboxil
Other interventions - No endothelial modulator
Treatment: Drugs - Imatinib
Other interventions - No Immune Modulator for Influenza
Treatment: Drugs - Tocilizumab
Treatment: Drugs - Baricitinib
Other interventions - No antiviral agent for COVID-19
Treatment: Drugs - Nirmatrelvir/ritonavir
Treatment: Drugs - Remdesivir
Treatment: Drugs - Nirmatrelvir/ritonavir + remdesivir

Other: Antibiotic Domain - Patients with community-acquired pneumonia admitted to participating intensive care units and requiring empiric antibiotic therapy will be randomised one of five antibiotic interventions.

Note: the ceftaroline + macrolide intervention has been closed to recruitment.

Other: Macrolide Duration Domain - Patients with community-acquired pneumonia admitted to participating intensive care units who have been allocated to a beta-lactam antibiotic intervention in the Antibiotic Domain will be randomised to either a standard course or extended course of macrolide therapy

Other: Corticosteroid Domain - Patients with community acquired pneumonia (CAP) admitted to participating hospitals will be randomised to a steroid use strategy.

Note: this domain is now closed to patients with suspected or proven COVID-19. It remains open to patients with CAP without COVID-19.

Note: the fixed-course hydrocortisone has been closed to recruitment

Other: Influenza Antiviral Domain - Patients with community-acquired pneumonia admitted to participating hospitals with microbiological testing confirmed influenza infection will be randomised to one of six interventions.

Other: COVID-19 Antiviral Domain - Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to no ivermectin or ivermectin.

Note: an earlier version of this domain evaluated lopinavir-ritonavir, hydroxychloroquine, and combination lopinavir-ritonavir and hydroxychloroquine against a 'no antiviral' control.

This domain is now closed.

Other: COVID-19 Immune Modulation Domain - Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to one of up to five interventions.

Note: this domain is now closed.

Other: Anticoagulation Domain - Patients admitted to participating intensive care units with suspected or microbiological testing confirmed COVID-19 will be randomised to an anticoagulation strategy.

Note: A previous version of this domain evaluated local standard venous thromboprophylaxis against therapeutic dose anticoagulation. This domain is now closed.

Other: Immunoglobulin Domain - Immunosuppressed patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to receive no immunoglobulin for COVID-19, or to receive high-titre convalescent plasma.

Note: an earlier version of this domain was not restricted to immunosuppressed patients.

Other: Vitamin C Domain - Patients admitted to participating hospitals with community-acquired pneumonia will be randomised to receive no vitamin C, or vitamin C.

Note: this domain is now closed.

Other: Simvastatin Domain - Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to receive no simvastatin, or simvastatin.

Note: this domain is now closed.

Other: Antiplatelet Domain - Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to receive no antiplatelet, aspirin, or site-preferred P2Y12 inhibitor.

Note: this domain is now closed.

Other: Mechanical Ventilation Domain - Patients with community-acquired pneumonia admitted to participating intensive care units who are intubated and receiving invasive mechanical ventilation will be randomised to protocolised mechanical ventilation strategy, or clinician-preferred mechanical ventilation strategy

Other: COVID-19 Immune Modulation (2) Domain - Patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to receive one of three interventions.

Note: this domain is now closed.

Other: ACE2 RAS Domain - Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to one of up to five renin-angiotensin system blockade strategies.

Note: this domain is now closed.

Other: Cysteamine Domain - Patients admitted to participating hospitals with severe community-acquired pneumonia, including patients with suspected or proven influenza or COVID-19, will be randomised to receive no cysteamine, or cysteamine.

Note: this domain is now closed.

Other: Endothelial Domain - Patients admitted to participating hospitals with severe community-acquired pneumonia, including patients with suspected or proven influenza or COVID-19, will be randomised to receive no endothelial modulator or enteral imatinib.

Other: Influenza Immune Modulation - Patients with community-acquired pneumonia admitted to participating intensive care units with microbiological testing confirmed influenza infection will be randomised to one of three interventions.

Other: COVID-19 Antiviral (II) Domain - Patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to one of up to four interventions.


Treatment: Drugs: Ceftriaxone
The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.

Treatment: Drugs: Moxifloxacin or Levofloxacin
The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.

Treatment: Drugs: Piperacillin-tazobactam
The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.

Treatment: Drugs: Ceftaroline
The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.

Note: this intervention is now closed.

Treatment: Drugs: Amoxicillin-clavulanate
The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.

Treatment: Drugs: Standard course macrolide
Standard course of macrolide therapy, discontinued between study day 3 and the end of study day 5.

The dosing of and route of administration is not protocolised, the following guidance is provided:

* Initial IV administration of a macrolide is strongly preferred
* The preferred IV macrolide is azithromycin, but IV clarithromycin may be substituted.
* The preferred enteral macrolide is azithromycin, but enteral clarithromycin or roxithromycin may be substituted.

Treatment: Drugs: Extended course macrolide
Extended course of macrolide therapy discontinued at the end of study day 14 or hospital discharge (whichever occurs first).

The dosing of and route of administration is not protocolised, the following guidance is provided:

* Initial IV administration of a macrolide is strongly preferred
* The preferred IV macrolide is azithromycin, but IV clarithromycin may be substituted.
* The preferred enteral macrolide is azithromycin, but enteral clarithromycin or roxithromycin may be substituted.

Other interventions: No systemic corticosteroid
Patients are not to receive any systemic corticosteroids, including hydrocortisone, to study day 28 or hospital discharge (whichever occurs first).

Treatment: Drugs: Fixed-duration Hydrocortisone
50mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.

Note: this intervention is now closed.

Treatment: Drugs: Shock-dependent hydrocortisone
50mg IV hydrocortisone every 6 hours while the patient is in septic shock

Treatment: Drugs: Fixed-duration higher dose Hydrocortisone
100mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.

Note: this intervention was only available to patients with suspected or proven COVID-19 and is now closed.

Other interventions: No antiviral agent for influenza
No antiviral agent intended to be active against influenza infection is to be administered

Treatment: Drugs: Five-days oseltamivir
Oseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first)

Treatment: Drugs: Ten-days oseltamivir
Oseltamivir administered enterally twice daily for 10 days or until hospital discharge (whichever occurs first)

Other interventions: No antiviral agent for COVID-19
No antiviral agent intended to be active against SARS-CoV-2 infection is to be administered

Treatment: Drugs: Lopinavir / Ritonavir
Lopinavir/ritonavir 400/100mg administered enterally, or 5ml 80/20mg per mL solution suspension via gastric tube, every 12 hours. Administered for a minimum of 5 days, including if discharged from ICU prior to end of study day 5. For patients discharged from ICU between study day 6 and study day 14, lopinavir/ritonavir is ceased at ICU discharge. Lopinavir/ritonavir is ceased at the end of study day 14 if the patient remains in ICU.

Note: this intervention is now closed.

Treatment: Drugs: Hydroxychloroquine
Loading dose of 800mg hydroxychloroquine administered enterally every 6 hours until 2 doses have been administered. Subsequently, 400mg hydroxychloroquine will be administered enterally every 12 hours for 12 doses or ICU discharge (whichever occurs first).

Note: this intervention is now closed.

Treatment: Drugs: Hydroxychloroquine + lopinavir/ritonavir
Lopinavir/ritonavir 400/100mg administered enterally, or 5ml 80/20mg per mL solution suspension via gastric tube, every 12 hours. Administered for a minimum of 5 days, including if discharged from ICU prior to end of study day 5. For patients discharged from ICU between study day 6 and study day 14, lopinavir/ritonavir is ceased at ICU discharge. Lopinavir/ritonavir is ceased at the end of study day 14 if the patient remains in ICU.

Loading dose of 800mg hydroxychloroquine administered enterally every 6 hours until 2 doses have been administered. Subsequently, 400mg hydroxychloroquine will be administered enterally every 12 hours for 12 doses or ICU discharge (whichever occurs first).

Note: this intervention is now closed.

Treatment: Drugs: Ivermectin
Ivermectin administered enterally at a dose of 0.2 mg/kg once daily with a maximum daily dose of 24mg/day.

Note: this intervention is now closed.

Other interventions: No immune modulation for COVID-19
No immune modulating agent intended to be active against COVID-19 is to be administered.

Note: this intervention is now closed.

Treatment: Drugs: Interferon beta-1a
IFN-ß1a 10 µg will be administered as an intravenous bolus injection via a central or peripheral line. IFN-ß1a will be administered once daily for 6 days or until ICU discharge, whichever occurs first.

Note: this intervention is now closed.

Treatment: Drugs: Anakinra
A loading dose of 300mg anakinra will be administered as a bolus via central or peripheral line. This is followed by maintenance doses of 100mg of anakinra administered every 6 hours.

In patients with renal impairment, anakinra will be administered on alternate days.

Note: this intervention is now closed.

Treatment: Drugs: Tocilizumab
Tocilizumab will be administered as a single dose of 8mg/kg estimated or measured body weight, with a maximum total dose of 800mg.

Tocilizumab will be administered as an IV infusion via central or peripheral line over a one-hour period.

Note: this intervention is now closed.

Treatment: Drugs: Sarilumab
Sarilumab will be administered as a single dose of 400mg, via IV infusion through peripheral or central line over a one-hour period.

Note: this intervention is now closed.

Treatment: Drugs: Local standard venous thromboprophylaxis
Standard venous thromboprophylaxis that complies with local guidelines or usual practice will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Treatment: Drugs: Therapeutic dose anticoagulation
Patients will be administered either low molecular weight heparin (LMWH) or unfractionated heparin (UFH) to achieve systemic anticoagulation. Either agent may be used and the same patient may be switched between UFH and LMWH at the discretion of the treating clinician.

Note: this intervention is now closed.

Treatment: Drugs: Conventional low dose thromboprophylaxis
Low dose thromboprophylaxis will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first. Dosing is outlined in the relevant protocol documents for this domain.

Treatment: Drugs: Intermediate dose thromboprophylaxis
Intermediate dose thromboprophylaxis will be administered for 14 days following randomisation or until hospital discharge, whichever occurs first. Dosing is outlined in the relevant protocol documents for this domain.

Treatment: Drugs: Continuation of therapeutic dose anticoagulation
Patients already receiving therapeutic dose anticoagulation at the time of randomisation to this intervention will be administered either unfractionated heparin by IV infusion or low-molecular weight heparin to achieve systemic anticoagulation according to local practice for acute VTE treatment for 14 days following randomisation or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Other interventions: No immunoglobulin
No immunoglobulin intended to be active against SARS-CoV-2 infection is to be administered.

Treatment: Other: Convalescent plasma
Patients will receive at least one and no more than two units of ABO compatible convalescent plasma within 48 hours of randomisation.

Treatment: Other: Delayed administration of convalescent plasma
Note: this intervention is now closed.

Other interventions: No vitamin C
No high dose intravenous vitamin C is to be administered

Note: this intervention is now closed.

Treatment: Drugs: Vitamin C
Intravenous Vitamin C 50mg/kg administered every 6 hours for 16 doses

Note: this intervention is now closed.

Other interventions: No antiplatelet
No antiplatelet agent or NSAID to be administered.

Note: this intervention is now closed.

Treatment: Drugs: Aspirin
Aspirin administered at either 75mg or 100mg once per day for 14 days or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Treatment: Drugs: P2Y12 inhibitor
Site-selected P2Y12 inhibitor:

* Clopidogrel: administered 75 mg once per day for 14 days or until hospital discharge, whichever occurs first.
* Prasugrel: If patient is aged less than 75 years and measured or estimated weight if 60kg or more, and initial loading dose of prasugrel 60 mg will be administered, followed by maintenance dose of 10 mg per day.
* Ticagrelor: administered enterally at 60mg twice daily for 14 days or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Other interventions: No simvastatin
No simvastatin intended to be active against COVID-19 is to be administered

Note: this intervention is now closed.

Treatment: Drugs: Simvastatin
Simvastatin 80mg administered once daily via enteral route, while the patient remains in hospital up to 28 days after randomisation

Note: this intervention is now closed.

Treatment: Drugs: Eritoran
Eritoran initiated with a 26.24 mg loading dose (6.56 mg/h IV for 4 hours), followed by a second 13.12 mg loading dose (6.56 mg/h IV for 2 hours) at 12 hours after initiation. Patients will then receive twenty-six 6.56 mg maintenance doses (3.28 mg/h IV for 2 hours) every 12 hours thereafter (total of 14 days). Dosing will be stopped if the patient is discharged from hospital

Note: this intervention is now closed.

Treatment: Drugs: Apremilast
Apremilast administered 30mg twice daily for 14 days or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Treatment: Surgery: Clinician-preferred mechanical ventilation strategy
Clinician-preferred ventilation strategy, including mode of ventilation and all ventilatory parameters

Treatment: Surgery: Protocolised mechanical ventilation strategy
Invasive mechanical ventilation strategy delivered as outlined in relevant protocol documents for this domain.

Other interventions: No renin-angiotensin system inhibitor
No RAS inhibitor (i.e. no ACEi or ARB) is to be administered up to the end of study day 10.

Note: this intervention is now closed.

Treatment: Drugs: Angiotensin converting enzyme inhibitor
Site-preferred ACEi agent administered as directed by the treating clinician for 10 days or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Treatment: Drugs: Angiotensin Receptor Blockers
Site-preferred ARB agent administered as directed by the treating clinician for 10 days or until hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Treatment: Drugs: ARB + DMX-200
Site-preferred ARB agent administered in combination with DMX-200 for 10 days or until hospital discharge, whichever occurs first.

ARB administered as directed by the treating clinician. DMX-200 administered enterally at a dose of 120mg twice daily.

Note: this intervention is now closed.

Other interventions: No cysteamine
No cysteamine to be administered until the end of study day 10 or hospital discharge, whichever occurs first.

Note: this intervention is now closed.

Treatment: Drugs: Cysteamine
Cysteamine administered every 8 hours at a dose of 5 mg/kg estimated or measured body weight (maximum dose of 500mg), for ten days or until ICU discharge, whichever occurs first.

Note: this intervention is now closed.

Treatment: Drugs: Fixed-duration dexamethasone
6 mg of IV or enteral dexamethasone will be administered daily for up to 10 days while in hospital.

Treatment: Drugs: Baloxavir Marboxil
Baloxavir marboxil administered on days 1 and 4 post-randomisation.

Treatment: Drugs: Five-days oseltamivir + baloxavir marboxil
Oseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first), in addition to baloxavir marboxil administered on days 1 and 4 post-randomisation.

Treatment: Drugs: Ten-days oseltamivir + baloxavir marboxil
Oseltamivir administered enterally twice daily for 10 days or until hospital discharge (whichever occurs first), in addition to baloxavir marboxil administered on days 1 and 4 post-randomisation.

Other interventions: No endothelial modulator
No endothelial modulator (imatinib or another tyrosine kinase inhibitor targeting the same pathway as imatinib) is to be administered.

Treatment: Drugs: Imatinib
Enteral imatinib will be administered as a single 800mg loading dose (study day 1) followed by 400mg daily until study day 14 or discharge.

Other interventions: No Immune Modulator for Influenza
No immune modulating agent intended to be active against influenza is to be administered.

Treatment: Drugs: Tocilizumab
Tocilizumab will be administered as a single dose of 8mg/kg estimated or measured body weight, with a maximum total dose of 800mg. In children weighing less than 30kg, tocilizumab dose will be 12mg/kg.

Tocilizumab will be administered as an IV infusion via central or peripheral line over a one-hour period.

Treatment: Drugs: Baricitinib
Baricitinib will be administered at a dose that is determined by age and renal function, for up to 10 days or hospital discharge (whichever occurs first).

Other interventions: No antiviral agent for COVID-19
No antiviral agent intended to be active against SARS-CoV-2 infection is to be administered

Treatment: Drugs: Nirmatrelvir/ritonavir
Nirmatrelvir-ritonavir will be administered at a dose that is dependent on renal function, for five days.

Treatment: Drugs: Remdesivir
Remdesivir is administered at 200 mg on day one followed by 100 mg daily for a further four doses (i.e., for five doses in total) or until hospital discharge, whichever occurs first.

Treatment: Drugs: Nirmatrelvir/ritonavir + remdesivir
Nirmatrelvir-ritonavir will be administered at a dose that is dependent on renal function, for five days. Remdesivir is administered at 200 mg on day one followed by 100 mg daily for a further four doses (i.e., for five doses in total) or until hospital discharge, whichever occurs first.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Other
Intervention code [4] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality
Timepoint [1] 0 0
Day 90
Primary outcome [2] 0 0
Days alive and not receiving organ support in ICU
Timepoint [2] 0 0
Day 21
Secondary outcome [1] 0 0
ICU Mortality
Timepoint [1] 0 0
Day 90
Secondary outcome [2] 0 0
ICU length of stay
Timepoint [2] 0 0
Day 90
Secondary outcome [3] 0 0
Hospital length of stay
Timepoint [3] 0 0
Day 90
Secondary outcome [4] 0 0
Ventilator free days
Timepoint [4] 0 0
Day 28
Secondary outcome [5] 0 0
Organ failure free days
Timepoint [5] 0 0
Day 28
Secondary outcome [6] 0 0
All-cause mortality
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Health-related Quality of life assessment
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Proportion of intubated patients who receive a tracheostomy
Timepoint [8] 0 0
Day 28
Secondary outcome [9] 0 0
Destination at time of hospital discharge
Timepoint [9] 0 0
Free text Day 90
Secondary outcome [10] 0 0
Readmission to the index ICU during the index hospitalization
Timepoint [10] 0 0
Day 90
Secondary outcome [11] 0 0
World Health Organisation 8-point ordinal scale outcome
Timepoint [11] 0 0
Hospital discharge

Eligibility
Key inclusion criteria
REMAP-CAP PLATFORM INCLUSION CRITERIA:

1. Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission with:

1. symptoms or signs or both that are consistent with lower respiratory tract infection AND
2. Radiological evidence of new onset consolidation (in patients with pre-existing radiological changes, evidence of new infiltrate)
2. Up to 48 hours after ICU admission, receiving organ support with one or more of:

1. Non-invasive or Invasive ventilatory support;
2. Receiving infusion of vasopressor or inotropes or both

PLATFORM EXCLUSION CRITERIA:

1. Healthcare-associated pneumonia:

1. Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days
2. Resident of a nursing home or long term care facility
2. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment
3. Previous participation in this REMAP within the last 90 days

REMAP-COVID PLATFORM INCLUSION CRITERIA

1. Adult patients (= 18 years) admitted to hospital with acute illness due to suspected or proven pandemic infection.

REMAP-COVID PLATFORM EXCLUSION CRITERIA

1. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment
2. Patient is expected to be discharged from hospital today or tomorrow
3. More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to suspected or proven pandemic infection.
4. Previous participation in this REMAP within the last 90 days

DOMAIN-SPECIFIC ELIGIBLE CRITERIA:

Each domain may have additional eligibility criteria. Refer to the study website for more information (www.remapcap.org).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2028
Actual
Sample size
Target
20000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [4] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [5] 0 0
Sutherland Hospital - Caringbah
Recruitment hospital [6] 0 0
Concord Hospital - Concord
Recruitment hospital [7] 0 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [8] 0 0
Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [9] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [10] 0 0
St. George Hospital - Kogarah
Recruitment hospital [11] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [12] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [13] 0 0
Orange Health Service - Orange
Recruitment hospital [14] 0 0
St Vincent's Hospital Sydney - Sydney
Recruitment hospital [15] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [16] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [17] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [18] 0 0
Wollongong Hospital - Sydney
Recruitment hospital [19] 0 0
Wagga Wagga Base Hospital - Wagga Wagga
Recruitment hospital [20] 0 0
Westmead Hospital - Westmead
Recruitment hospital [21] 0 0
Royal Darwin Hospital, - Darwin
Recruitment hospital [22] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [23] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [24] 0 0
Mater Hospital Brisbane - Brisbane
Recruitment hospital [25] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [26] 0 0
Caboolture Hospital - Caboolture
Recruitment hospital [27] 0 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [28] 0 0
Logan Hospital - Logan
Recruitment hospital [29] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [30] 0 0
Rockhampton Hospital - Rockhampton
Recruitment hospital [31] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [32] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [33] 0 0
Townsville Hospital - Townsville
Recruitment hospital [34] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [35] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [36] 0 0
Lyell McEwin Hospital - Adelaide
Recruitment hospital [37] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [38] 0 0
Launceston Hospital - Launceston
Recruitment hospital [39] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [40] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [41] 0 0
Casey Hospital - Berwick
Recruitment hospital [42] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [43] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [44] 0 0
Dandenong Hospital - Dandenong
Recruitment hospital [45] 0 0
Angliss Hospital - Ferntree Gully
Recruitment hospital [46] 0 0
Footscray Hospital - Footscray
Recruitment hospital [47] 0 0
University Hosptial Geelong - Geelong
Recruitment hospital [48] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [49] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [50] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment hospital [51] 0 0
Maroondah Hospital - Ringwood East
Recruitment hospital [52] 0 0
Sunshine Hospital - Sunshine
Recruitment hospital [53] 0 0
Werribee Mercy Hospital - Werribee
Recruitment hospital [54] 0 0
St John of God Hospital Midland - Midland
Recruitment hospital [55] 0 0
St John of God Hospital Murdoch - Murdoch
Recruitment hospital [56] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [57] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [58] 0 0
Fiona Stanley Hospital - Perth
Recruitment hospital [59] 0 0
St John of God Subiaco - Subiaco
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2200 - Bankstown
Recruitment postcode(s) [3] 0 0
2148 - Blacktown
Recruitment postcode(s) [4] 0 0
2560 - Campbelltown
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Funding & Sponsors
Primary sponsor type
Other
Name
UMC Utrecht
Address
Country
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Other
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Australian and New Zealand Intensive Care Research Centre
Address [1] 0 0
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Other
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Medical Research Institute of New Zealand
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Other
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Unity Health
Address [3] 0 0
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Other
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Berry Consultants
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Other
Name [5] 0 0
Global Coalition for Adaptive Research
Address [5] 0 0
Country [5] 0 0
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Other
Name [6] 0 0
University of Pittsburgh Medical Center
Address [6] 0 0
Country [6] 0 0
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Other
Name [7] 0 0
Intensive Care National Audit & Research Centre
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Other
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St. Marianna University School of Medicine
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Other
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Nat Intensive Care Surveillance - MORU
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
National University Hospital, Singapore
Address [10] 0 0
Country [10] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steve Webb, Prof
Address 0 0
Monash University, Study Chair REMAP-CAP Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cameron Green, MSc
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
info@remapcap.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02735707