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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]

2015-002340-14

Secondary ID [2]

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

Condition category

Condition code

Infection

Other infectious diseases

Respiratory

Other respiratory disorders / diseases

Infection

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]

Treatment: Drugs

Intervention code [2]

Other interventions

Intervention code [3]

Treatment: Other

Intervention code [4]

Treatment: Surgery

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

All-cause mortality

Timepoint [1]

Day 90

Primary outcome [2]

Days alive and not receiving organ support in ICU

Timepoint [2]

Day 21

Secondary outcome [1]

ICU Mortality

Timepoint [1]

Day 90

Secondary outcome [2]

ICU length of stay

Timepoint [2]

Day 90

Secondary outcome [3]

Hospital length of stay

Timepoint [3]

Day 90

Secondary outcome [4]

Ventilator free days

Timepoint [4]

Day 28

Secondary outcome [5]

Organ failure free days

Timepoint [5]

Day 28

Secondary outcome [6]

All-cause mortality

Timepoint [6]

6 months

Secondary outcome [7]

Health-related Quality of life assessment

Timepoint [7]

6 months

Secondary outcome [8]

Proportion of intubated patients who receive a tracheostomy

Timepoint [8]

Day 28

Secondary outcome [9]

Destination at time of hospital discharge

Timepoint [9]

Free text Day 90

Secondary outcome [10]

Readmission to the index ICU during the index hospitalization

Timepoint [10]

Day 90

Secondary outcome [11]

World Health Organisation 8-point ordinal scale outcome

Timepoint [11]

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?

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]

Canberra Hospital - Canberra

Recruitment hospital [2]

Bankstown-Lidcombe Hospital - Bankstown

Recruitment hospital [3]

Blacktown Hospital - Blacktown

Recruitment hospital [4]

Campbelltown Hospital - Campbelltown

Recruitment hospital [5]

Sutherland Hospital - Caringbah

Recruitment hospital [6]

Concord Hospital - Concord

Recruitment hospital [7]

Dubbo Base Hospital - Dubbo

Recruitment hospital [8]

Northern Beaches Hospital - Frenchs Forest

Recruitment hospital [9]

Nepean Hospital - Kingswood

Recruitment hospital [10]

St. George Hospital - Kogarah

Recruitment hospital [11]

Liverpool Hospital - Liverpool

Recruitment hospital [12]

John Hunter Hospital - Newcastle

Recruitment hospital [13]

Orange Health Service - Orange

Recruitment hospital [14]

St Vincent's Hospital Sydney - Sydney

Recruitment hospital [15]

Prince of Wales Hospital - Sydney

Recruitment hospital [16]

Royal Prince Alfred Hospital - Sydney

Recruitment hospital [17]

Royal North Shore Hospital - Sydney

Recruitment hospital [18]

Wollongong Hospital - Sydney

Recruitment hospital [19]

Wagga Wagga Base Hospital - Wagga Wagga

Recruitment hospital [20]

Westmead Hospital - Westmead

Recruitment hospital [21]

Royal Darwin Hospital, - Darwin

Recruitment hospital [22]

Sunshine Coast University Hospital - Birtinya

Recruitment hospital [23]

The Prince Charles Hospital - Brisbane

Recruitment hospital [24]

Mater Hospital Brisbane - Brisbane

Recruitment hospital [25]

Princess Alexandra Hospital - Brisbane

Recruitment hospital [26]

Caboolture Hospital - Caboolture

Recruitment hospital [27]

Queen Elizabeth II Jubilee Hospital - Coopers Plains

Recruitment hospital [28]

Logan Hospital - Logan

Recruitment hospital [29]

Redcliffe Hospital - Redcliffe

Recruitment hospital [30]

Rockhampton Hospital - Rockhampton

Recruitment hospital [31]

Gold Coast University Hospital - Southport

Recruitment hospital [32]

Toowoomba Hospital - Toowoomba

Recruitment hospital [33]

Townsville Hospital - Townsville

Recruitment hospital [34]

Royal Adelaide Hospital - Adelaide

Recruitment hospital [35]

The Queen Elizabeth Hospital - Adelaide

Recruitment hospital [36]

Lyell McEwin Hospital - Adelaide

Recruitment hospital [37]

Flinders Medical Centre - Bedford Park

Recruitment hospital [38]

Launceston Hospital - Launceston

Recruitment hospital [39]

Ballarat Base Hospital - Ballarat

Recruitment hospital [40]

Bendigo Hospital - Bendigo

Recruitment hospital [41]

Casey Hospital - Berwick

Recruitment hospital [42]

Box Hill Hospital - Box Hill

Recruitment hospital [43]

Monash Medical Centre - Clayton

Recruitment hospital [44]

Dandenong Hospital - Dandenong

Recruitment hospital [45]

Angliss Hospital - Ferntree Gully

Recruitment hospital [46]

Footscray Hospital - Footscray

Recruitment hospital [47]

University Hosptial Geelong - Geelong

Recruitment hospital [48]

The Alfred Hospital - Melbourne

Recruitment hospital [49]

Royal Melbourne Hospital - Melbourne

Recruitment hospital [50]

St Vincent's Hospital Melbourne - Melbourne

Recruitment hospital [51]

Maroondah Hospital - Ringwood East

Recruitment hospital [52]

Sunshine Hospital - Sunshine

Recruitment hospital [53]

Werribee Mercy Hospital - Werribee

Recruitment hospital [54]

St John of God Hospital Midland - Midland

Recruitment hospital [55]

St John of God Hospital Murdoch - Murdoch

Recruitment hospital [56]

Royal Perth Hospital - Perth

Recruitment hospital [57]

Sir Charles Gairdner Hospital - Perth

Recruitment hospital [58]

Fiona Stanley Hospital - Perth

Recruitment hospital [59]

St John of God Subiaco - Subiaco

Recruitment postcode(s) [1]

2605 - Canberra

Recruitment postcode(s) [2]

2200 - Bankstown

Recruitment postcode(s) [3]

2148 - Blacktown

Recruitment postcode(s) [4]

2560 - Campbelltown

Recruitment postcode(s) [5]

2229 - Caringbah

Recruitment postcode(s) [6]

2139 - Concord

Recruitment postcode(s) [7]

2830 - Dubbo

Recruitment postcode(s) [8]

2086 - Frenchs Forest

Recruitment postcode(s) [9]

2750 - Kingswood

Recruitment postcode(s) [10]

2217 - Kogarah

Recruitment postcode(s) [11]

2170 - Liverpool

Recruitment postcode(s) [12]

2305 - Newcastle

Recruitment postcode(s) [13]

2800 - Orange

Recruitment postcode(s) [14]

2010 - Sydney

Recruitment postcode(s) [15]

2031 - Sydney

Recruitment postcode(s) [16]

2050 - Sydney

Recruitment postcode(s) [17]

2065 - Sydney

Recruitment postcode(s) [18]

2500 - Sydney

Recruitment postcode(s) [19]

2650 - Wagga Wagga

Recruitment postcode(s) [20]

2145 - Westmead

Recruitment postcode(s) [21]

0810 - Darwin

Recruitment postcode(s) [22]

4575 - Birtinya

Recruitment postcode(s) [23]

4032 - Brisbane

Recruitment postcode(s) [24]

4101 - Brisbane

Recruitment postcode(s) [25]

4102 - Brisbane

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4510 - Caboolture

Recruitment postcode(s) [27]

4110 - Coopers Plains

Recruitment postcode(s) [28]

4129 - Logan

Recruitment postcode(s) [29]

4020 - Redcliffe

Recruitment postcode(s) [30]

4700 - Rockhampton

Recruitment postcode(s) [31]

4215 - Southport

Recruitment postcode(s) [32]

4350 - Toowoomba

Recruitment postcode(s) [33]

4814 - Townsville

Recruitment postcode(s) [34]

5000 - Adelaide

Recruitment postcode(s) [35]

5011 - Adelaide

Recruitment postcode(s) [36]

5112 - Adelaide

Recruitment postcode(s) [37]

5042 - Bedford Park

Recruitment postcode(s) [38]

7250 - Launceston

Recruitment postcode(s) [39]

3350 - Ballarat

Recruitment postcode(s) [40]

3550 - Bendigo

Recruitment postcode(s) [41]

3806 - Berwick

Recruitment postcode(s) [42]

3128 - Box Hill

Recruitment postcode(s) [43]

3168 - Clayton

Recruitment postcode(s) [44]

3175 - Dandenong

Recruitment postcode(s) [45]

3156 - Ferntree Gully

Recruitment postcode(s) [46]

3011 - Footscray

Recruitment postcode(s) [47]

3220 - Geelong

Recruitment postcode(s) [48]

3004 - Melbourne

Recruitment postcode(s) [49]

3050 - Melbourne

Recruitment postcode(s) [50]

3065 - Melbourne

Recruitment postcode(s) [51]

3135 - Ringwood East

Recruitment postcode(s) [52]

3021 - Sunshine

Recruitment postcode(s) [53]

3030 - Werribee

Recruitment postcode(s) [54]

6056 - Midland

Recruitment postcode(s) [55]

6150 - Murdoch

Recruitment postcode(s) [56]

6000 - Perth

Recruitment postcode(s) [57]

6009 - Perth

Recruitment postcode(s) [58]

6150 - Perth

Recruitment postcode(s) [59]

6008 - Subiaco

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Florida

Country [2]

United States of America

State/province [2]

Georgia

Country [3]

United States of America

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Illinois

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United States of America

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Louisiana

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United States of America

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Michigan

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United States of America

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New York

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United States of America

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North Carolina

Country [8]

United States of America

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Ohio

Country [9]

United States of America

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Oregon

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United States of America

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Pennsylvania

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United States of America

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Rhode Island

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Belgium

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Charleroi

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Belgium

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Gent

Country [14]

Belgium

State/province [14]

Namur

Country [15]

Canada

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Alberta

Country [16]

Canada

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British Columbia

Country [17]

Canada

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Manitoba

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Canada

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New Brunswick

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Canada

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Ontario

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Canada

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Quebec

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Canada

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Saskatchewan

Country [22]

Colombia

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Cundinamarca

Country [23]

Croatia

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Požega

Country [24]

Croatia

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Zagreb

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Czechia

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Prague

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Czechia

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Teplice

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Estonia

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Tartu

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Finland

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Helsinki

Country [29]

Finland

State/province [29]

Tampere

Country [30]

France

State/province [30]

Argenteuil

Country [31]

France

State/province [31]

Aurillac

Country [32]

France

State/province [32]

Beauvais

Country [33]

France

State/province [33]

Belfort

Country [34]

France

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Boulogne-Billancourt

Country [35]

France

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Béthune

Country [36]

France

State/province [36]

Dax

Country [37]

France

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Dieppe

Country [38]

France

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Dijon

Country [39]

France

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Eaubonne

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France

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Garches

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France

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La Roche-sur-Yon

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France

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Le Mans

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France

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Limoges

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France

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Melun

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France

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Mont-de-Marsan

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France

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Morlaix

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France

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Orléans

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France

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Paris

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France

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Strasbourg

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France

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Tours

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France

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Étampes

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Germany

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Berlin

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Germany

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Cottbus

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Germany

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Dortmund

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Germany

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Essen

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Germany

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Frankfurt

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Germany

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Hamburg

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Germany

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Jena

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Germany

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Köln

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Germany

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Leipzig

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Germany

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München

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Germany

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Münster

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Germany

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Tübingen

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Germany

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Würzburg

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Hungary

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Nyíregyháza

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Hungary

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Ózd

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India

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Tamil Nadu

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Ireland

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Cork

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Ireland

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Dublin

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Ireland

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Galway

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Ireland

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Waterford

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Israel

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Haifa

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Israel

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Petah-Tikva

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Israel

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Poriyya

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Italy

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Brescia

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Italy

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Milan

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Italy

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Palermo

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Italy

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Reggio Emilia

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Rimini

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Kumamoto

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Japan

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Osaka

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Japan

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Tokyo

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Japan

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Wakayama

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Nepal

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Bharatpur

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Nepal

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Kathmandu

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Netherlands

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Almelo

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Amersfoort

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Netherlands

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Amsterdam

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Netherlands

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Arnhem

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Netherlands

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Den Bosch

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Netherlands

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Den Haag

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Netherlands

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Deventer

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Netherlands

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Ede

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Netherlands

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Eindhoven

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Netherlands

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Groningen

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Netherlands

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Leeuwarden

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Netherlands

State/province [98]

Leiden

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Netherlands

State/province [99]

Nijmegen

Country [100]

Netherlands

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Roermond

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Netherlands

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Rotterdam

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Netherlands

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Uden

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Netherlands

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Utrecht

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New Zealand

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Auckland

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New Zealand

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Christchurch

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New Zealand

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Hamilton

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New Zealand

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New Plymouth

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New Zealand

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Rotorua

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New Zealand

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Tauranga

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New Zealand

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Wellington

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New Zealand

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Whangarei

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Pakistan

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Sindh

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Portugal

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Abrantes

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Portugal

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Lisboa

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Romania

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Bucharest

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Saudi Arabia

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Riyadh

Country [117]

Serbia

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Belgrade

Country [118]

Serbia

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Belgrad

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Serbia

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Niš

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Slovenia

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Golnik

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Slovenia

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Maribor

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Spain

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Barcelona

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Spain

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Cadiz

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Spain

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Córdoba

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Spain

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Madrid

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Spain

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Málaga

Country [127]

Spain

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Ourense

Country [128]

Spain

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Santander

Country [129]

Spain

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Tortosa

Country [130]

Spain

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Valencia

Country [131]

Switzerland

State/province [131]

Zürich

Country [132]

United Kingdom

State/province [132]

England

Country [133]

United Kingdom

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Northern Ireland

Country [134]

United Kingdom

State/province [134]

Scotland

Country [135]

United Kingdom

State/province [135]

Wales

Country [136]

United Kingdom

State/province [136]

Belfast

Country [137]

United Kingdom

State/province [137]

Bristol

Country [138]

United Kingdom

State/province [138]

Bury

Country [139]

United Kingdom

State/province [139]

Crewe

Country [140]

United Kingdom

State/province [140]

Dorchester

Country [141]

United Kingdom

State/province [141]

Gloucester

Country [142]

United Kingdom

State/province [142]

Haywards Heath

Country [143]

United Kingdom

State/province [143]

Leeds

Country [144]

United Kingdom

State/province [144]

London

Country [145]

United Kingdom

State/province [145]

Margate

Country [146]

United Kingdom

State/province [146]

Newcastle Upon Tyne

Country [147]

United Kingdom

State/province [147]

North Shields

Country [148]

United Kingdom

State/province [148]

Warwick

Country [149]

United Kingdom

State/province [149]

West Bromwich

Funding & Sponsors

Primary sponsor type

Other

Name

UMC Utrecht

Address

Country

Other collaborator category [1]

Other

Name [1]

Australian and New Zealand Intensive Care Research Centre

Address [1]

Country [1]

Other collaborator category [2]

Other

Name [2]

Medical Research Institute of New Zealand

Address [2]

Country [2]

Other collaborator category [3]

Other

Name [3]

Unity Health

Address [3]

Country [3]

Other collaborator category [4]

Other

Name [4]

Berry Consultants

Address [4]

Country [4]

Other collaborator category [5]

Other

Name [5]

Global Coalition for Adaptive Research

Address [5]

Country [5]

Other collaborator category [6]

Other

Name [6]

University of Pittsburgh Medical Center

Address [6]

Country [6]

Other collaborator category [7]

Other

Name [7]

Intensive Care National Audit & Research Centre

Address [7]

Country [7]

Other collaborator category [8]

Other

Name [8]

St. Marianna University School of Medicine

Address [8]

Country [8]

Other collaborator category [9]

Other

Name [9]

Nat Intensive Care Surveillance - MORU

Address [9]

Country [9]

Other collaborator category [10]

Other

Name [10]

National University Hospital, Singapore

Address [10]

Country [10]

Ethics approval

Ethics application status

Summary

Brief summary

REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia.

The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia.

In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic such as COVID-19.

REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19 in the United States of America.

Trial website

https://clinicaltrials.gov/study/NCT02735707

Trial related presentations / publications

REMAP-CAP Writing Committee for the REMAP-CAP Investigators; Bradbury CA, Lawler PR, Stanworth SJ, McVerry BJ, McQuilten Z, Higgins AM, Mouncey PR, Al-Beidh F, Rowan KM, Berry LR, Lorenzi E, Zarychanski R, Arabi YM, Annane D, Beane A, van Bentum-Puijk W, Bhimani Z, Bihari S, Bonten MJM, Brunkhorst FM, Buzgau A, Buxton M, Carrier M, Cheng AC, Cove M, Detry MA, Estcourt LJ, Fitzgerald M, Girard TD, Goligher EC, Goossens H, Haniffa R, Hills T, Huang DT, Horvat CM, Hunt BJ, Ichihara N, Lamontagne F, Leavis HL, Linstrum KM, Litton E, Marshall JC, McAuley DF, McGlothlin A, McGuinness SP, Middeldorp S, Montgomery SK, Morpeth SC, Murthy S, Neal MD, Nichol AD, Parke RL, Parker JC, Reyes LF, Saito H, Santos MS, Saunders CT, Serpa-Neto A, Seymour CW, Shankar-Hari M, Singh V, Tolppa T, Turgeon AF, Turner AM, van de Veerdonk FL, Green C, Lewis RJ, Angus DC, McArthur CJ, Berry S, Derde LPG, Webb SA, Gordon AC. Effect of Antiplatelet Therapy on Survival and Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2022 Apr 5;327(13):1247-1259. doi: 10.1001/jama.2022.2910.
Writing Committee for the REMAP-CAP Investigators; Estcourt LJ, Turgeon AF, McQuilten ZK, McVerry BJ, Al-Beidh F, Annane D, Arabi YM, Arnold DM, Beane A, Begin P, van Bentum-Puijk W, Berry LR, Bhimani Z, Birchall JE, Bonten MJM, Bradbury CA, Brunkhorst FM, Buxton M, Callum JL, Chasse M, Cheng AC, Cove ME, Daly J, Derde L, Detry MA, De Jong M, Evans A, Fergusson DA, Fish M, Fitzgerald M, Foley C, Goossens H, Gordon AC, Gosbell IB, Green C, Haniffa R, Harvala H, Higgins AM, Hills TE, Hoad VC, Horvat C, Huang DT, Hudson CL, Ichihara N, Laing E, Lamikanra AA, Lamontagne F, Lawler PR, Linstrum K, Litton E, Lorenzi E, MacLennan S, Marshall J, McAuley DF, McDyer JF, McGlothlin A, McGuinness S, Miflin G, Montgomery S, Mouncey PR, Murthy S, Nichol A, Parke R, Parker JC, Priddee N, Purcell DFJ, Reyes LF, Richardson P, Robitaille N, Rowan KM, Rynne J, Saito H, Santos M, Saunders CT, Serpa Neto A, Seymour CW, Silversides JA, Tinmouth AA, Triulzi DJ, Turner AM, van de Veerdonk F, Walsh TS, Wood EM, Berry S, Lewis RJ, Menon DK, McArthur C, Zarychanski R, Angus DC, Webb SA, Roberts DJ, Shankar-Hari M. Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2021 Nov 2;326(17):1690-1702. doi: 10.1001/jama.2021.18178.
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
REMAP-CAP Investigators; ACTIV-4a Investigators; ATTACC Investigators; Goligher EC, Bradbury CA, McVerry BJ, Lawler PR, Berger JS, Gong MN, Carrier M, Reynolds HR, Kumar A, Turgeon AF, Kornblith LZ, Kahn SR, Marshall JC, Kim KS, Houston BL, Derde LPG, Cushman M, Tritschler T, Angus DC, Godoy LC, McQuilten Z, Kirwan BA, Farkouh ME, Brooks MM, Lewis RJ, Berry LR, Lorenzi E, Gordon AC, Ahuja T, Al-Beidh F, Annane D, Arabi YM, Aryal D, Baumann Kreuziger L, Beane A, Bhimani Z, Bihari S, Billett HH, Bond L, Bonten M, Brunkhorst F, Buxton M, Buzgau A, Castellucci LA, Chekuri S, Chen JT, Cheng AC, Chkhikvadze T, Coiffard B, Contreras A, Costantini TW, de Brouwer S, Detry MA, Duggal A, Dzavik V, Effron MB, Eng HF, Escobedo J, Estcourt LJ, Everett BM, Fergusson DA, Fitzgerald M, Fowler RA, Froess JD, Fu Z, Galanaud JP, Galen BT, Gandotra S, Girard TD, Goodman AL, Goossens H, Green C, Greenstein YY, Gross PL, Haniffa R, Hegde SM, Hendrickson CM, Higgins AM, Hindenburg AA, Hope AA, Horowitz JM, Horvat CM, Huang DT, Hudock K, Hunt BJ, Husain M, Hyzy RC, Jacobson JR, Jayakumar D, Keller NM, Khan A, Kim Y, Kindzelski A, King AJ, Knudson MM, Kornblith AE, Kutcher ME, Laffan MA, Lamontagne F, Le Gal G, Leeper CM, Leifer ES, Lim G, Gallego Lima F, Linstrum K, Litton E, Lopez-Sendon J, Lother SA, Marten N, Saud Marinez A, Martinez M, Mateos Garcia E, Mavromichalis S, McAuley DF, McDonald EG, McGlothlin A, McGuinness SP, Middeldorp S, Montgomery SK, Mouncey PR, Murthy S, Nair GB, Nair R, Nichol AD, Nicolau JC, Nunez-Garcia B, Park JJ, Park PK, Parke RL, Parker JC, Parnia S, Paul JD, Pompilio M, Quigley JG, Rosenson RS, Rost NS, Rowan K, Santos FO, Santos M, Santos MO, Satterwhite L, Saunders CT, Schreiber J, Schutgens REG, Seymour CW, Siegal DM, Silva DG Jr, Singhal AB, Slutsky AS, Solvason D, Stanworth SJ, Turner AM, van Bentum-Puijk W, van de Veerdonk FL, van Diepen S, Vazquez-Grande G, Wahid L, Wareham V, Widmer RJ, Wilson JG, Yuriditsky E, Zhong Y, Berry SM, McArthur CJ, Neal MD, Hochman JS, Webb SA, Zarychanski R. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19. N Engl J Med. 2021 Aug 26;385(9):777-789. doi: 10.1056/NEJMoa2103417. Epub 2021 Aug 4.
ATTACC Investigators; ACTIV-4a Investigators; REMAP-CAP Investigators; Lawler PR, Goligher EC, Berger JS, Neal MD, McVerry BJ, Nicolau JC, Gong MN, Carrier M, Rosenson RS, Reynolds HR, Turgeon AF, Escobedo J, Huang DT, Bradbury CA, Houston BL, Kornblith LZ, Kumar A, Kahn SR, Cushman M, McQuilten Z, Slutsky AS, Kim KS, Gordon AC, Kirwan BA, Brooks MM, Higgins AM, Lewis RJ, Lorenzi E, Berry SM, Berry LR, Aday AW, Al-Beidh F, Annane D, Arabi YM, Aryal D, Baumann Kreuziger L, Beane A, Bhimani Z, Bihari S, Billett HH, Bond L, Bonten M, Brunkhorst F, Buxton M, Buzgau A, Castellucci LA, Chekuri S, Chen JT, Cheng AC, Chkhikvadze T, Coiffard B, Costantini TW, de Brouwer S, Derde LPG, Detry MA, Duggal A, Dzavik V, Effron MB, Estcourt LJ, Everett BM, Fergusson DA, Fitzgerald M, Fowler RA, Galanaud JP, Galen BT, Gandotra S, Garcia-Madrona S, Girard TD, Godoy LC, Goodman AL, Goossens H, Green C, Greenstein YY, Gross PL, Hamburg NM, Haniffa R, Hanna G, Hanna N, Hegde SM, Hendrickson CM, Hite RD, Hindenburg AA, Hope AA, Horowitz JM, Horvat CM, Hudock K, Hunt BJ, Husain M, Hyzy RC, Iyer VN, Jacobson JR, Jayakumar D, Keller NM, Khan A, Kim Y, Kindzelski AL, King AJ, Knudson MM, Kornblith AE, Krishnan V, Kutcher ME, Laffan MA, Lamontagne F, Le Gal G, Leeper CM, Leifer ES, Lim G, Lima FG, Linstrum K, Litton E, Lopez-Sendon J, Lopez-Sendon Moreno JL, Lother SA, Malhotra S, Marcos M, Saud Marinez A, Marshall JC, Marten N, Matthay MA, McAuley DF, McDonald EG, McGlothlin A, McGuinness SP, Middeldorp S, Montgomery SK, Moore SC, Morillo Guerrero R, Mouncey PR, Murthy S, Nair GB, Nair R, Nichol AD, Nunez-Garcia B, Pandey A, Park PK, Parke RL, Parker JC, Parnia S, Paul JD, Perez Gonzalez YS, Pompilio M, Prekker ME, Quigley JG, Rost NS, Rowan K, Santos FO, Santos M, Olombrada Santos M, Satterwhite L, Saunders CT, Schutgens REG, Seymour CW, Siegal DM, Silva DG Jr, Shankar-Hari M, Sheehan JP, Singhal AB, Solvason D, Stanworth SJ, Tritschler T, Turner AM, van Bentum-Puijk W, van de Veerdonk FL, van Diepen S, Vazquez-Grande G, Wahid L, Wareham V, Wells BJ, Widmer RJ, Wilson JG, Yuriditsky E, Zampieri FG, Angus DC, McArthur CJ, Webb SA, Farkouh ME, Hochman JS, Zarychanski R. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19. N Engl J Med. 2021 Aug 26;385(9):790-802. doi: 10.1056/NEJMoa2105911. Epub 2021 Aug 4.
Arabi YM, Gordon AC, Derde LPG, Nichol AD, Murthy S, Beidh FA, Annane D, Swaidan LA, Beane A, Beasley R, Berry LR, Bhimani Z, Bonten MJM, Bradbury CA, Brunkhorst FM, Buxton M, Buzgau A, Cheng A, De Jong M, Detry MA, Duffy EJ, Estcourt LJ, Fitzgerald M, Fowler R, Girard TD, Goligher EC, Goossens H, Haniffa R, Higgins AM, Hills TE, Horvat CM, Huang DT, King AJ, Lamontagne F, Lawler PR, Lewis R, Linstrum K, Litton E, Lorenzi E, Malakouti S, McAuley DF, McGlothlin A, Mcguinness S, McVerry BJ, Montgomery SK, Morpeth SC, Mouncey PR, Orr K, Parke R, Parker JC, Patanwala AE, Rowan KM, Santos MS, Saunders CT, Seymour CW, Shankar-Hari M, Tong SYC, Turgeon AF, Turner AM, Van de Veerdonk FL, Zarychanski R, Green C, Berry S, Marshall JC, McArthur C, Angus DC, Webb SA; REMAP-CAP Investigators. Lopinavir-ritonavir and hydroxychloroquine for critically ill patients with COVID-19: REMAP-CAP randomized controlled trial. Intensive Care Med. 2021 Aug;47(8):867-886. doi: 10.1007/s00134-021-06448-5. Epub 2021 Jul 12.
REMAP-CAP Investigators; Gordon AC, Mouncey PR, Al-Beidh F, Rowan KM, Nichol AD, Arabi YM, Annane D, Beane A, van Bentum-Puijk W, Berry LR, Bhimani Z, Bonten MJM, Bradbury CA, Brunkhorst FM, Buzgau A, Cheng AC, Detry MA, Duffy EJ, Estcourt LJ, Fitzgerald M, Goossens H, Haniffa R, Higgins AM, Hills TE, Horvat CM, Lamontagne F, Lawler PR, Leavis HL, Linstrum KM, Litton E, Lorenzi E, Marshall JC, Mayr FB, McAuley DF, McGlothlin A, McGuinness SP, McVerry BJ, Montgomery SK, Morpeth SC, Murthy S, Orr K, Parke RL, Parker JC, Patanwala AE, Pettila V, Rademaker E, Santos MS, Saunders CT, Seymour CW, Shankar-Hari M, Sligl WI, Turgeon AF, Turner AM, van de Veerdonk FL, Zarychanski R, Green C, Lewis RJ, Angus DC, McArthur CJ, Berry S, Webb SA, Derde LPG. Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19. N Engl J Med. 2021 Apr 22;384(16):1491-1502. doi: 10.1056/NEJMoa2100433. Epub 2021 Feb 25.
UPMC REMAP-COVID Group, on behalf of the REMAP-CAP Investigators. Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system-lessons learned and recommendations. Trials. 2021 Jan 28;22(1):100. doi: 10.1186/s13063-020-04997-6. Erratum In: Trials. 2021 Feb 16;22(1):145. doi: 10.1186/s13063-021-05109-8.
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Angus DC, Derde L, Al-Beidh F, Annane D, Arabi Y, Beane A, van Bentum-Puijk W, Berry L, Bhimani Z, Bonten M, Bradbury C, Brunkhorst F, Buxton M, Buzgau A, Cheng AC, de Jong M, Detry M, Estcourt L, Fitzgerald M, Goossens H, Green C, Haniffa R, Higgins AM, Horvat C, Hullegie SJ, Kruger P, Lamontagne F, Lawler PR, Linstrum K, Litton E, Lorenzi E, Marshall J, McAuley D, McGlothin A, McGuinness S, McVerry B, Montgomery S, Mouncey P, Murthy S, Nichol A, Parke R, Parker J, Rowan K, Sanil A, Santos M, Saunders C, Seymour C, Turner A, van de Veerdonk F, Venkatesh B, Zarychanski R, Berry S, Lewis RJ, McArthur C, Webb SA, Gordon AC; Writing Committee for the REMAP-CAP Investigators; Al-Beidh F, Angus D, Annane D, Arabi Y, van Bentum-Puijk W, Berry S, Beane A, Bhimani Z, Bonten M, Bradbury C, Brunkhorst F, Buxton M, Cheng A, De Jong M, Derde L, Estcourt L, Goossens H, Gordon A, Green C, Haniffa R, Lamontagne F, Lawler P, Litton E, Marshall J, McArthur C, McAuley D, McGuinness S, McVerry B, Montgomery S, Mouncey P, Murthy S, Nichol A, Parke R, Rowan K, Seymour C, Turner A, van de Veerdonk F, Webb S, Zarychanski R, Campbell L, Forbes A, Gattas D, Heritier S, Higgins L, Kruger P, Peake S, Presneill J, Seppelt I, Trapani T, Young P, Bagshaw S, Daneman N, Ferguson N, Misak C, Santos M, Hullegie S, Pletz M, Rohde G, Rowan K, Alexander B, Basile K, Girard T, Horvat C, Huang D, Linstrum K, Vates J, Beasley R, Fowler R, McGloughlin S, Morpeth S, Paterson D, Venkatesh B, Uyeki T, Baillie K, Duffy E, Fowler R, Hills T, Orr K, Patanwala A, Tong S, Netea M, Bihari S, Carrier M, Fergusson D, Goligher E, Haidar G, Hunt B, Kumar A, Laffan M, Lawless P, Lother S, McCallum P, Middeldopr S, McQuilten Z, Neal M, Pasi J, Schutgens R, Stanworth S, Turgeon A, Weissman A, Adhikari N, Anstey M, Brant E, de Man A, Lamonagne F, Masse MH, Udy A, Arnold D, Begin P, Charlewood R, Chasse M, Coyne M, Cooper J, Daly J, Gosbell I, Harvala-Simmonds H, Hills T, MacLennan S, Menon D, McDyer J, Pridee N, Roberts D, Shankar-Hari M, Thomas H, Tinmouth A, Triulzi D, Walsh T, Wood E, Calfee C, O'Kane C, Shyamsundar M, Sinha P, Thompson T, Young I, Bihari S, Hodgson C, Laffey J, McAuley D, Orford N, Neto A, Detry M, Fitzgerald M, Lewis R, McGlothlin A, Sanil A, Saunders C, Berry L, Lorenzi E, Miller E, Singh V, Zammit C, van Bentum Puijk W, Bouwman W, Mangindaan Y, Parker L, Peters S, Rietveld I, Raymakers K, Ganpat R, Brillinger N, Markgraf R, Ainscough K, Brickell K, Anjum A, Lane JB, Richards-Belle A, Saull M, Wiley D, Bion J, Connor J, Gates S, Manax V, van der Poll T, Reynolds J, van Beurden M, Effelaar E, Schotsman J, Boyd C, Harland C, Shearer A, Wren J, Clermont G, Garrard W, Kalchthaler K, King A, Ricketts D, Malakoutis S, Marroquin O, Music E, Quinn K, Cate H, Pearson K, Collins J, Hanson J, Williams P, Jackson S, Asghar A, Dyas S, Sutu M, Murphy S, Williamson D, Mguni N, Potter A, Porter D, Goodwin J, Rook C, Harrison S, Williams H, Campbell H, Lomme K, Williamson J, Sheffield J, van't Hoff W, McCracken P, Young M, Board J, Mart E, Knott C, Smith J, Boschert C, Affleck J, Ramanan M, D'Souza R, Pateman K, Shakih A, Cheung W, Kol M, Wong H, Shah A, Wagh A, Simpson J, Duke G, Chan P, Cartner B, Hunter S, Laver R, Shrestha T, Regli A, Pellicano A, McCullough J, Tallott M, Kumar N, Panwar R, Brinkerhoff G, Koppen C, Cazzola F, Brain M, Mineall S, Fischer R, Biradar V, Soar N, White H, Estensen K, Morrison L, Smith J, Cooper M, Health M, Shehabi Y, Al-Bassam W, Hulley A, Whitehead C, Lowrey J, Gresha R, Walsham J, Meyer J, Harward M, Venz E, Williams P, Kurenda C, Smith K, Smith M, Garcia R, Barge D, Byrne D, Byrne K, Driscoll A, Fortune L, Janin P, Yarad E, Hammond N, Bass F, Ashelford A, Waterson S, Wedd S, McNamara R, Buhr H, Coles J, Schweikert S, Wibrow B, Rauniyar R, Myers E, Fysh E, Dawda A, Mevavala B, Litton E, Ferrier J, Nair P, Buscher H, Reynolds C, Santamaria J, Barbazza L, Homes J, Smith R, Murray L, Brailsford J, Forbes L, Maguire T, Mariappa V, Smith J, Simpson S, Maiden M, Bone A, Horton M, Salerno T, Sterba M, Geng W, Depuydt P, De Waele J, De Bus L, Fierens J, Bracke S, Reeve B, Dechert W, Chasse M, Carrier FM, Boumahni D, Benettaib F, Ghamraoui A, Bellemare D, Cloutier E, Francoeur C, Lamontagne F, D'Aragon F, Carbonneau E, Leblond J, Vazquez-Grande G, Marten N, Wilson M, Albert M, Serri K, Cavayas A, Duplaix M, Williams V, Rochwerg B, Karachi T, Oczkowski S, Centofanti J, Millen T, Duan E, Tsang J, Patterson L, English S, Watpool I, Porteous R, Miezitis S, McIntyre L, Brochard L, Burns K, Sandhu G, Khalid I, Binnie A, Powell E, McMillan A, Luk T, Aref N, Andric Z, Cviljevic S, Dimoti R, Zapalac M, Mirkovic G, Barsic B, Kutlesa M, Kotarski V, Vujaklija Brajkovic A, Babel J, Sever H, Dragija L, Kusan I, Vaara S, Pettila L, Heinonen J, Kuitunen A, Karlsson S, Vahtera A, Kiiski H, Ristimaki S, Azaiz A, Charron C, Godement M, Geri G, Vieillard-Baron A, Pourcine F, Monchi M, Luis D, Mercier R, Sagnier A, Verrier N, Caplin C, Siami S, Aparicio C, Vautier S, Jeblaoui A, Fartoukh M, Courtin L, Labbe V, Leparco C, Muller G, Nay MA, Kamel T, Benzekri D, Jacquier S, Mercier E, Chartier D, Salmon C, Dequin P, Schneider F, Morel G, L'Hotellier S, Badie J, Berdaguer FD, Malfroy S, Mezher C, Bourgoin C, Megarbane B, Voicu S, Deye N, Malissin I, Sutterlin L, Guitton C, Darreau C, Landais M, Chudeau N, Robert A, Moine P, Heming N, Maxime V, Bossard I, Nicholier TB, Colin G, Zinzoni V, Maquigneau N, Finn A, Kress G, Hoff U, Friedrich Hinrichs C, Nee J, Pletz M, Hagel S, Ankert J, Kolanos S, Bloos F, Petros S, Pasieka B, Kunz K, Appelt P, Schutze B, Kluge S, Nierhaus A, Jarczak D, Roedl K, Weismann D, Frey A, Klinikum Neukolln V, Reill L, Distler M, Maselli A, Belteczki J, Magyar I, Fazekas A, Kovacs S, Szoke V, Szigligeti G, Leszkoven J, Collins D, Breen P, Frohlich S, Whelan R, McNicholas B, Scully M, Casey S, Kernan M, Doran P, O'Dywer M, Smyth M, Hayes L, Hoiting O, Peters M, Rengers E, Evers M, Prinssen A, Bosch Ziekenhuis J, Simons K, Rozendaal W, Polderman F, de Jager P, Moviat M, Paling A, Salet A, Rademaker E, Peters AL, de Jonge E, Wigbers J, Guilder E, Butler M, Cowdrey KA, Newby L, Chen Y, Simmonds C, McConnochie R, Ritzema Carter J, Henderson S, Van Der Heyden K, Mehrtens J, Williams T, Kazemi A, Song R, Lai V, Girijadevi D, Everitt R, Russell R, Hacking D, Buehner U, Williams E, Browne T, Grimwade K, Goodson J, Keet O, Callender O, Martynoga R, Trask K, Butler A, Schischka L, Young C, Lesona E, Olatunji S, Robertson Y, Jose N, Amaro dos Santos Catorze T, de Lima Pereira TNA, Neves Pessoa LM, Castro Ferreira RM, Pereira Sousa Bastos JM, Aysel Florescu S, Stanciu D, Zaharia MF, Kosa AG, Codreanu D, Marabi Y, Al Qasim E, Moneer Hagazy M, Al Swaidan L, Arishi H, Munoz-Bermudez R, Marin-Corral J, Salazar Degracia A, Parrilla Gomez F, Mateo Lopez MI, Rodriguez Fernandez J, Carcel Fernandez S, Carmona Flores R, Leon Lopez R, de la Fuente Martos C, Allan A, Polgarova P, Farahi N, McWilliam S, Hawcutt D, Rad L, O'Malley L, Whitbread J, Kelsall O, Wild L, Thrush J, Wood H, Austin K, Donnelly A, Kelly M, O'Kane S, McClintock D, Warnock M, Johnston P, Gallagher LJ, Mc Goldrick C, Mc Master M, Strzelecka A, Jha R, Kalogirou M, Ellis C, Krishnamurthy V, Deelchand V, Silversides J, McGuigan P, Ward K, O'Neill A, Finn S, Phillips B, Mullan D, Oritz-Ruiz de Gordoa L, Thomas M, Sweet K, Grimmer L, Johnson R, Pinnell J, Robinson M, Gledhill L, Wood T, Morgan M, Cole J, Hill H, Davies M, Antcliffe D, Templeton M, Rojo R, Coghlan P, Smee J, Mackay E, Cort J, Whileman A, Spencer T, Spittle N, Kasipandian V, Patel A, Allibone S, Genetu RM, Ramali M, Ghosh A, Bamford P, London E, Cawley K, Faulkner M, Jeffrey H, Smith T, Brewer C, Gregory J, Limb J, Cowton A, O'Brien J, Nikitas N, Wells C, Lankester L, Pulletz M, Williams P, Birch J, Wiseman S, Horton S, Alegria A, Turki S, Elsefi T, Crisp N, Allen L, McCullagh I, Robinson P, Hays C, Babio-Galan M, Stevenson H, Khare D, Pinder M, Selvamoni S, Gopinath A, Pugh R, Menzies D, Mackay C, Allan E, Davies G, Puxty K, McCue C, Cathcart S, Hickey N, Ireland J, Yusuff H, Isgro G, Brightling C, Bourne M, Craner M, Watters M, Prout R, Davies L, Pegler S, Kyeremeh L, Arbane G, Wilson K, Gomm L, Francia F, Brett S, Sousa Arias S, Elin Hall R, Budd J, Small C, Birch J, Collins E, Henning J, Bonner S, Hugill K, Cirstea E, Wilkinson D, Karlikowski M, Sutherland H, Wilhelmsen E, Woods J, North J, Sundaran D, Hollos L, Coburn S, Walsh J, Turns M, Hopkins P, Smith J, Noble H, Depante MT, Clarey E, Laha S, Verlander M, Williams A, Huckle A, Hall A, Cooke J, Gardiner-Hill C, Maloney C, Qureshi H, Flint N, Nicholson S, Southin S, Nicholson A, Borgatta B, Turner-Bone I, Reddy A, Wilding L, Chamara Warnapura L, Agno Sathianathan R, Golden D, Hart C, Jones J, Bannard-Smith J, Henry J, Birchall K, Pomeroy F, Quayle R, Makowski A, Misztal B, Ahmed I, KyereDiabour T, Naiker K, Stewart R, Mwaura E, Mew L, Wren L, Willams F, Innes R, Doble P, Hutter J, Shovelton C, Plumb B, Szakmany T, Hamlyn V, Hawkins N, Lewis S, Dell A, Gopal S, Ganguly S, Smallwood A, Harris N, Metherell S, Lazaro JM, Newman T, Fletcher S, Nortje J, Fottrell-Gould D, Randell G, Zaman M, Elmahi E, Jones A, Hall K, Mills G, Ryalls K, Bowler H, Sall J, Bourne R, Borrill Z, Duncan T, Lamb T, Shaw J, Fox C, Moreno Cuesta J, Xavier K, Purohit D, Elhassan M, Bakthavatsalam D, Rowland M, Hutton P, Bashyal A, Davidson N, Hird C, Chhablani M, Phalod G, Kirkby A, Archer S, Netherton K, Reschreiter H, Camsooksai J, Patch S, Jenkins S, Pogson D, Rose S, Daly Z, Brimfield L, Claridge H, Parekh D, Bergin C, Bates M, Dasgin J, McGhee C, Sim M, Hay SK, Henderson S, Phull MK, Zaidi A, Pogreban T, Rosaroso LP, Harvey D, Lowe B, Meredith M, Ryan L, Hormis A, Walker R, Collier D, Kimpton S, Oakley S, Rooney K, Rodden N, Hughes E, Thomson N, McGlynn D, Walden A, Jacques N, Coles H, Tilney E, Vowell E, Schuster-Bruce M, Pitts S, Miln R, Purandare L, Vamplew L, Spivey M, Bean S, Burt K, Moore L, Day C, Gibson C, Gordon E, Zitter L, Keenan S, Baker E, Cherian S, Cutler S, Roynon-Reed A, Harrington K, Raithatha A, Bauchmuller K, Ahmad N, Grecu I, Trodd D, Martin J, Wrey Brown C, Arias AM, Craven T, Hope D, Singleton J, Clark S, Rae N, Welters I, Hamilton DO, Williams K, Waugh V, Shaw D, Puthucheary Z, Martin T, Santos F, Uddin R, Somerville A, Tatham KC, Jhanji S, Black E, Dela Rosa A, Howle R, Tully R, Drummond A, Dearden J, Philbin J, Munt S, Vuylsteke A, Chan C, Victor S, Matsa R, Gellamucho M, Creagh-Brown B, Tooley J, Montague L, De Beaux F, Bullman L, Kersiake I, Demetriou C, Mitchard S, Ramos L, White K, Donnison P, Johns M, Casey R, Mattocks L, Salisbury S, Dark P, Claxton A, McLachlan D, Slevin K, Lee S, Hulme J, Joseph S, Kinney F, Senya HJ, Oborska A, Kayani A, Hadebe B, Orath Prabakaran R, Nichols L, Thomas M, Worner R, Faulkner B, Gendall E, Hayes K, Hamilton-Davies C, Chan C, Mfuko C, Abbass H, Mandadapu V, Leaver S, Forton D, Patel K, Paramasivam E, Powell M, Gould R, Wilby E, Howcroft C, Banach D, Fernandez de Pinedo Artaraz Z, Cabreros L, White I, Croft M, Holland N, Pereira R, Zaki A, Johnson D, Jackson M, Garrard H, Juhaz V, Roy A, Rostron A, Woods L, Cornell S, Pillai S, Harford R, Rees T, Ivatt H, Sundara Raman A, Davey M, Lee K, Barber R, Chablani M, Brohi F, Jagannathan V, Clark M, Purvis S, Wetherill B, Dushianthan A, Cusack R, de Courcy-Golder K, Smith S, Jackson S, Attwood B, Parsons P, Page V, Zhao XB, Oza D, Rhodes J, Anderson T, Morris S, Xia Le Tai C, Thomas A, Keen A, Digby S, Cowley N, Wild L, Southern D, Reddy H, Campbell A, Watkins C, Smuts S, Touma O, Barnes N, Alexander P, Felton T, Ferguson S, Sellers K, Bradley-Potts J, Yates D, Birkinshaw I, Kell K, Marshall N, Carr-Knott L, Summers C. Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial. JAMA. 2020 Oct 6;324(13):1317-1329. doi: 10.1001/jama.2020.17022.
Angus DC, Berry S, Lewis RJ, Al-Beidh F, Arabi Y, van Bentum-Puijk W, Bhimani Z, Bonten M, Broglio K, Brunkhorst F, Cheng AC, Chiche JD, De Jong M, Detry M, Goossens H, Gordon A, Green C, Higgins AM, Hullegie SJ, Kruger P, Lamontagne F, Litton E, Marshall J, McGlothlin A, McGuinness S, Mouncey P, Murthy S, Nichol A, O'Neill GK, Parke R, Parker J, Rohde G, Rowan K, Turner A, Young P, Derde L, McArthur C, Webb SA. The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design. Ann Am Thorac Soc. 2020 Jul;17(7):879-891. doi: 10.1513/AnnalsATS.202003-192SD.

Public notes

Contacts

Principal investigator

Name

Steve Webb, Prof

Address

Monash University, Study Chair REMAP-CAP Australia

Country

Phone

Fax

Contact person for public queries

Name

Cameron Green, MSc

Address

Country

Phone

Fax

[email protected]

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

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