Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (REMAP-CAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02735707

Recruitment Status : Recruiting

First Posted : April 13, 2016

Last Update Posted : October 12, 2020

See Contacts and Locations

Sponsor:

Collaborators:

Australian and New Zealand Intensive Care Research Centre

Medical Research Institute of New Zealand

Unity Health

Berry Consultants

Global Coalition for Adaptive Research

University of Pittsburgh Medical Center

Information provided by (Responsible Party):

MJM Bonten, UMC Utrecht

Study Description

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 resulting in critical illness.

REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19.

Condition or disease	Intervention/treatment	Phase
Community-acquired Pneumonia, Influenza, COVID-19	Drug: Fixed-duration Hydrocortisone Drug: Shock-dependent hydrocortisone Drug: Ceftriaxone Drug: Moxifloxacin or Levofloxacin Drug: Piperacillin-tazobactam Drug: Ceftaroline Drug: Amoxicillin-clavulanate Drug: Macrolide administered for 3-5 days Drug: Macrolide administered for up to 14 days Drug: Five-days oseltamivir Drug: Ten-days oseltamivir Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine Drug: Hydroxychloroquine + lopinavir/ritonavir Drug: Interferon-β1a Drug: Anakinra Drug: Fixed-duration higher dose Hydrocortisone Drug: Tocilizumab Drug: Sarilumab Drug: Vitamin C Drug: Therapeutic anticoagulation Drug: Simvastatin Biological: Convalescent plasma Other: Protocolised mechanical ventilation strategy Drug: Eritoran Drug: Apremilast Drug: Aspirin Drug: Clopidogrel Drug: Prasugrel Drug: Ticagrelor	Phase 4

Detailed Description:

Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an intensive care unit (ICU) is associated with substantial mortality.

Patients with pneumonia who are being treated in an ICU will receive therapy that consists of many different treatments, as many as 20 or 30. These treatments act together to treat both the infection and its effects on the body. When treating a patient, doctors choose from many different treatments, most of which are known or believed to be safe and effective. However, doctors don't always know which treatment option is the better one, as individuals or groups of individuals may respond differently. This study aims to help doctors understand which treatments work best.

This clinical study has been designed in a way that allows the information from patients already in the study to help new patients joining the study. Most studies aren't able to do that. REMAP-CAP has been designed to:

Evaluate multiple treatment strategies, at the same time, in the same patient.
Reach platform conclusions when sufficient data is accrued, rather than when a pre-specified sample size is reached
Utilise data that is already accrued to increase the likelihood that patients within the trial are randomised to treatments that are more likely to be beneficial
New questions can be substituted into the trial as initial questions are answered, meaning that the trial can be perpetual or open-ended
Interactions between interventions in different domains can be evaluated

It is reasonable to presume that any pandemic respiratory infection of major significance to public health will manifest as life-threatening respiratory infection including Severe Acute Respiratory illness and severe Community Acquired Pneumonia (CAP) with concomitant admission to hospital, and for some patients, admission to an Intensive Care Unit (ICU). Previous pandemics and more localized outbreaks of respiratory emerging infections have resulted in severe CAP and ICU admission.

Previous pandemics and outbreaks of emerging infectious diseases have outlined the urgent need for evidence, preferably from Randomized Controlled Trials (RCTs), to guide best treatment. However, there are substantial challenges associated with being able to organize such trials when the time of onset of a pandemic and its exact nature are unpredictable. As an adaptive platform trial that enrolls patients during the interpandemic period, REMAP-CAP is ideally positioned to adapt, in the event of a respiratory pandemic, to evaluate existing treatments as well as novel approaches.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	7100 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Actual Study Start Date :	April 11, 2016
Estimated Primary Completion Date :	December 2021
Estimated Study Completion Date :	December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Corticosteroid Domain: fixed-duration Hydrocortisone The patient will receive IV Hydrocortisone 50 mg every 6 hours for up to 7 days.	Drug: Fixed-duration Hydrocortisone 50mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.
No Intervention: Corticosteroid Domain:No systemic corticosteroid (no placebo) The patient will receive no systemic corticosteroid for the treatment of CAP or its direct complications, up until study day 28.
Active Comparator: Corticosteroid Domain: shock dependant Hydrocortisone The patient will receive hydrocortisone (50mg IV every 6 hours) while the patient is in septic shock.	Drug: Shock-dependent hydrocortisone Patient will receive 50mg IV hydrocortisone every 6 hours while the patient is in septic shock
Active Comparator: Antibiotic Domain: Ceftriaxone + Macrolide Ceftriaxone and site preferred macrolide will be administered for empiric antibiotic therapy	Drug: Ceftriaxone The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
Active Comparator: Antibiotic Domain: Moxifloxacin or Levofloxacin Moxifloxacin or levofloxacin will be administered for empiric antibiotic therapy	Drug: Moxifloxacin or Levofloxacin The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
Active Comparator: Antibiotic Domain: Piperacillin-tazobactam + Macrolide Piperacillin-tazobactam and site preferred macrolide will be administered for empiric antibiotic therapy	Drug: Piperacillin-tazobactam The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
Active Comparator: Antibiotic Domain: Ceftaroline + Macrolide Ceftaroline and site preferred macrolide will be administered for empiric antibiotic therapy	Drug: Ceftaroline The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice. Ceftaroline is not available at commencement
Active Comparator: Antibiotic Domain: Amoxicillin-clavulanate + Macrolide Amoxicillin-clavunate and site preferred macrolide will be administered for empiric antibiotic therapy	Drug: Amoxicillin-clavulanate The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
Active Comparator: Macrolide Duration Domain: Standard course macrolide The patient will receive macrolide therapy for 3-5 days. This arm is nested within the Antibiotic Domain.	Drug: Macrolide administered for 3-5 days 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. Other Name: Standard course macrolide
Active Comparator: Macrolide Duration Domain: Extended course macrolide The patient will receive macrolide therapy for up to 14 days. This arm is nested within the Antibiotic Domain.	Drug: Macrolide administered for up to 14 days 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 Name: Extended course macrolide
No Intervention: No antiviral agent active against influenza (no placebo) The patient will receive no antiviral agent active against influenza, including oseltamivir.
Active Comparator: Five-day course of Oseltamivir The patient will receive a five-day course of oseltamivir.	Drug: Five-days oseltamivir Oseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first)
Active Comparator: 10-day course of oseltamivir The patient will receive a ten-day course of oseltamivir.	Drug: Ten-days oseltamivir Oseltamivir administered enterally twice daily for 10 days or until hospital discharge (whichever occurs first)
No Intervention: No antiviral for COVID-19 The patient will receive no antiviral agent intended to be active against SARS-CoV-2 infection.
Active Comparator: Lopinavir/ritonavir for COVID-19 Patients will receive lopinavir/ritonavir (kaletra) 400/100mg enterally every 12 hours intended to be active against SARS-CoV-2 infection.	Drug: 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. Other Name: Kaletra
Active Comparator: Hydroxychloroquine for COVID-19 Patients will receive hydroxychloroquine intended to be active against SARS-CoV-2 infection.	Drug: 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).
Active Comparator: Hydroxychloroquine + lopinavir/ritonavir for COVID-19 Patients will receive both hydroxychloroquine and lopinavir/ritonavir intended to be active against SARS-CoV-2 infection.	Drug: 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).
No Intervention: No immune modulation for COVID-19 Patients will not receive any immune modulating therapy intended to be active against COVID-19.
Active Comparator: Interferon-β1a for COVID-19 Patients will receive Interferon-β1a intended to be active against COVID-19.	Drug: Interferon-β1a IFN-β1a 10 μg will be administered as an intravenous bolus injection via a central or peripheral line. IFN-β1a will be administered once daily for 6 days or until ICU discharge, whichever occurs first. Other Name: IFN-β1a
Active Comparator: Anakinra (interleukin-1 receptor antagonist) for COVID-19 Patients will receive anakinra intended to be active against COVID-19.	Drug: 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 very 6 hours. In patients with renal impairment, anakinra will be administered on alternate days. Other Name: Interleukin-1 receptor antagonist (IL-1Ra)
Active Comparator: Fixed-duration higher dose Hydrocortisone The patient will receive IV Hydrocortisone 100mg every 6 hours for up to 7 days.	Drug: Fixed-duration higher dose Hydrocortisone 100mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.
Active Comparator: Tocilizumab Patients will receive Tocilizumab intended to be active against COVID-19	Drug: 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.
Active Comparator: Sarilumab Patients will receive Sarilumab intended to be active against COVID-19	Drug: Sarilumab Sarilumab will be administered as a single dose of 400mg, via IV infusion through peripheral or central line over a one-hour period.
No Intervention: No Vitamin C Patients will not receive vitamin c (no placebo)
Active Comparator: Vitamin C Patients will receive IV Vitamin C (50mg/kg every 6 hours for 16 doses)	Drug: Vitamin C Vitamin C 50mg/kg administered IV every 6 hours for 16 doses
No Intervention: Standard Care Thromboprophylaxis Patients will receive local standard care thromboprophylaxis for 14 days.
Active Comparator: Therapeutic Anticoagulation Therapeutic anticoagulation with IV unfractionated heparin or subcutaneous low molecular weight heparin.	Drug: Therapeutic anticoagulation Patients will be administered either low molecular weight heparin or unfractionated heparin 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.
No Intervention: No simvastatin Patients will not receive simvastatin for up to 28 days while the patient remains in hospital.
Active Comparator: Simvastatin Patients will receive simvastatin (80mg enterally once daily) for up to 28 days while the patient remains in hospital.	Drug: Simvastatin Simvastatin 80mg administered once daily via enteral route, while the patient remains in hospital up to 28 days after randomisation
No Intervention: No immunoglobulin against SARS-CoV-2 Patients will not receive any preparation of immunoglobulin intended to neutralise SARS-CoV-2 during the index hospitalisation.
Active Comparator: Convalescent plasma Patients will receive at least one, and not more than two, units of convalescent plasma within 48 hours of randomisation.	Biological: Convalescent plasma Patients will recieve at least one and no more than two units of ABO compatible convalescent plasma within 48 hours of randomisation.
No Intervention: Clinician-preferred invasive ventilation Patients will receive invasive mechanical ventilation as determined by the treating clinician.
Active Comparator: Protocolised invasive mechanical ventilation strategy Patient will receive a protocolised invasive mechanical ventilation strategy	Other: Protocolised mechanical ventilation strategy See Domain Specific Appendix for a complete description of protoclised invasive mechanical ventilation strategy.
Active Comparator: Eritoran Patients will receive Eritoran intended to be active against COVID-19	Drug: 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
Active Comparator: Apremilast Patients will receive Apremilast intended to be active against COVID-19	Drug: Apremilast Apremilast administered 30mg twice daily for 14 days or until hospital discharge, whichever occurs first.
No Intervention: No antiplatelet Patients will not receive any antiplatelet agent or NSAID for 14 days while patient remains in hospital
Active Comparator: Aspirin Patients will receive aspirin for up to 14 days while the patient remains in hospital	Drug: Aspirin Aspiring administered at either 75mg or 100mg once per day for 14 days or until hospital discharge, whichever occurs first. Other Name: acetylsalicylic acid
Active Comparator: P2Y12 inhibitor Patients will receive either clopidogrel, prasugrel, or ticagrelor (as per site preference).	Drug: Clopidogrel Clopidogrel administered 75 mg once per day for 14 days or until hospital discharge, whichever occurs first. Drug: 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. If patient's age is more than 75 years, or measured or estimated weight is less than 60kg, an initial loading dose of 60mg will be administered, followed by 5mg per day. Prasugrel will be administered for 14 days or until hospital discharge, whichever occurs first. Drug: Ticagrelor Ticagrelor administered enterally at 60mg twice daily for 14 days or until hospital discharge, whichever occurs first.

Outcome Measures

Primary Outcome Measures :

All-cause mortality [ Time Frame: Day 90 ]
Days alive and not receiving organ support in ICU [ Time Frame: Day 21 ]
Primary end-point for patients with suspected or proven COVID-19 pandemic infection

Secondary Outcome Measures :

ICU Mortality [ Time Frame: Day 90 ]
ICU length of stay [ Time Frame: Day 90 ]
Hospital length of stay [ Time Frame: Day 90 ]
Ventilator free days [ Time Frame: Day 28 ]
Organ failure free days [ Time Frame: Day 28 ]
All-cause mortality [ Time Frame: 6 months ]
Health-related Quality of life assessment [ Time Frame: 6 months ]
EQ5D-5L and WHODAS 2.0 (not completed in all regions)
Proportion of intubated patients who receive a tracheostomy [ Time Frame: Day 28 ]
Destination at time of hospital discharge [ Time Frame: Free text Day 90 ]
Characterised as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital
Readmission to the index ICU during the index hospitalization [ Time Frame: Day 90 ]
World Health Organisation 8-point ordinal scale outcome [ Time Frame: Hospital discharge ]

Other Outcome Measures:

Occurrence of multi-resistant organism colonisation/infection [ Time Frame: Day 90, censored at hospital discharge ]
Antibiotic Domain specific outcome
Occurrence clostridium difficile [ Time Frame: Day 90, censored at hospital discharge ]
Antibiotic Domain specific outcome
Occurrence of serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death [ Time Frame: Day 90, censored at hospital discharge ]
Macrolide Duration domain specific outcome, and COVID-19 Antiviral Domain specific outcome.
Change from baseline influenza virus levels in upper and lower respiratory tract specimens [ Time Frame: Day 3, up to Day 7 ]
Antiviral Domain specific outcome. Only required at selected sites.
Serial detection of SARS-CoV-2 in upper or lower respiratory tract specimens (using only specimens collected for routine clinical testing) [ Time Frame: Day 90, censored at hospital discharge ]
COVID-19 Antiviral Domain and COVID-19 Immune Modulation Domain specific endpoint

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

REMAP-CAP PLATFORM INCLUSION CRITERIA:

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)
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:

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
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
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

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
Patient is expected to be discharged from hospital today or tomorrow
More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to suspected or proven pandemic infection.
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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735707

Contacts

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Contact: Cameron Green		info@remapcap.org
Contact: Wilma Van Bentum-Puijk, MSc	+31 (0) 88 755 5555	prepare_icu@umcutrecht.nl

Locations

Show 90 study locations

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United States, Pennsylvania
University of Pittsburgh Medical Centre	Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Stephanie Mongomery stephaniemontgomery@pitt.edu
Australia, New South Wales
St Vincent's Hospital Sydney	Recruiting
Sydney, New South Wales, Australia, 2010
Royal Prince Alfred Hospital	Not yet recruiting
Sydney, New South Wales, Australia, 2050
Royal North Shore Hospital	Recruiting
Sydney, New South Wales, Australia, 2065
Nepean Hospital	Recruiting
Sydney, New South Wales, Australia, 2747
Wollongong Hospital	Recruiting
Sydney, New South Wales, Australia, 8808
Australia, Northern Territory
Royal Darwin Hospital,	Not yet recruiting
Darwin, Northern Territory, Australia, 0810
Australia, Queensland
Sunshine Coast University Hospital	Not yet recruiting
Birtinya, Queensland, Australia, 4575
Princess Alexandra Hospital	Recruiting
Brisbane, Queensland, Australia, 4102
Logan Hospital	Not yet recruiting
Brisbane, Queensland, Australia, 4131
Toowoomba Hospital	Recruiting
Toowoomba, Queensland, Australia, 4350
Australia, South Australia
The Queen Elizabeth Hospital	Recruiting
Adelaide, South Australia, Australia, 5011
Australia, Victoria
Bendigo Hospital	Recruiting
Bendigo, Victoria, Australia, 3550
University Hosptial Geelong	Recruiting
Geelong, Victoria, Australia, 3220
The Alfred Hospital	Recruiting
Melbourne, Victoria, Australia, 3004
Royal Melbourne Hospital	Recruiting
Melbourne, Victoria, Australia, 3050
St Vincent's Hospital Melbourne	Recruiting
Melbourne, Victoria, Australia, 3065
Australia, Western Australia
Royal Perth Hospital	Recruiting
Perth, Western Australia, Australia, 6000
Sir Charles Gairdner Hospital	Recruiting
Perth, Western Australia, Australia, 6009
St John of God Hospital Midland	Recruiting
Perth, Western Australia, Australia, 6056
Fiona Stanley Hospital	Recruiting
Perth, Western Australia, Australia, 6150
St John of God Hospital Murdoch	Not yet recruiting
Perth, Western Australia, Australia, 6150
Belgium
AZ Sint-Jan	Not yet recruiting
Brugge, Belgium, 8000
Contact: Marc Bourgeois, MD
CHU de Charleroi - Hôpital Civil Marie Curie	Not yet recruiting
Charleroi, Belgium, 6042
Contact: Patrick Biston, MD
Universitair Ziekenhuis Antwerp	Not yet recruiting
Edegem, Belgium, 2650
Contact: Philippe Jorens, Prof.
Universitair Ziekenhuis Gent	Recruiting
Gent, Belgium, 9000
Contact: Pieter Depuydt, Prof. Pieter.Depuydt@UGent.be
Canada
St. Joseph's Healthcare Hamilton	Recruiting
Hamilton, Canada
Contact: Deborah Cook, MD
Centre Hospitalier de l'Université de Sherbrooke	Recruiting
Sherbrooke, Canada
Contact: Francois Lamontagne, MD
St. Michael's Hospital Unity Health Toronto	Recruiting
Toronto, Canada
Contact: John Marshall, MD
Croatia
General County Hospital Požega	Recruiting
Požega, Croatia, 34000
Contact: Zdravko Andrić, MD
University Hospital Centre Zagreb	Recruiting
Zagreb, Croatia, 10000
Contact: Ana Vujaklija Brajković, MD
University Hospital for Infectious Diseases	Recruiting
Zagreb, Croatia, 10000
Contact: Bruno Barsić, MD
Germany
Charité - Universitätsmedizin Berlin - Infektiologie und Pneumologie	Not yet recruiting
Berlin, Germany, 10117
Contact: Martin Witzenrath, Prof. Dr.
Charité - Universitätsmedizin Berlin - Nephrologie	Not yet recruiting
Berlin, Germany, 10117
Contact: André Finn, MD
Vivantes Klinikum Neukölln	Not yet recruiting
Berlin, Germany, 12351
Contact: Lorenz Reill, MD
Universitätsklinikum Köln	Not yet recruiting
Cologne, Germany, 50937
Contact: Lars Pester
Universitätsklinikum Frankfurt	Not yet recruiting
Frankfurt, Germany, 60590
Contact: Gernot Rohde, Prof. Dr.
University Medical Center Hamburg-Eppendorf (UKE)	Not yet recruiting
Hamburg, Germany, 20251
Contact: Stefan Klug, Prof. Dr.
Medizinische Hochschule Hannover	Not yet recruiting
Hannover, Germany, 30625
Contact: Sascha David, MD
Universitätsklinikum Jena	Recruiting
Jena, Germany, 07747
Contact: Mathias W. Pletz, Prof. Dr. mathias.pletz@med.uni-jena.de
Universitätsklinikum Leipzig	Recruiting
Leipzig, Germany, 04103
Contact: Sirak Petros, Prof. Dr. Sirak.Petros@uniklinik-leipzig.de
Universitäts Klinikum Tübingen	Not yet recruiting
Tübingen, Germany, 72076
Contact: Siri Göpel, MD
Universitätsklinikum Würzburg	Not yet recruiting
Würzburg, Germany, 97080
Contact: Dirk Weismann, MD
Hungary
Jósa András County Hospital	Recruiting
Nyíregyháza, Hungary, 4400
Contact: Gábor Szigligeti, MD
Csolnoky Ferenc Kórház - Veszprem County Hospital	Not yet recruiting
Veszprém, Hungary, 8200
Contact: Béla Gál, MD
Almási Balogh Pál Kórház	Recruiting
Ózd, Hungary, 3600
Contact: János Bélteczki, MD
Ireland
Beaumont Hospital	Not yet recruiting
Dublin, Ireland
Contact: Ger Curley, Prof.
St. Vincent's University Hospital	Recruiting
Dublin, Ireland
Contact: Alistair Nichol, Prof.
Contact alistair.nichol@ucd.ie
University Hospital Galway	Recruiting
Galway, Ireland
Contact: John Laffey, M.D.
Netherlands
Meander Medisch Centrum	Recruiting
Amersfoort, Netherlands
Contact: Laura van Gulik, M.D.
Jeroen Bosch Ziekenhuis	Recruiting
Den Bosch, Netherlands
Contact: Koen Simons, M.D.
Martini Hospital Groningen	Withdrawn
Groningen, Netherlands
University Medical Center Groningen	Withdrawn
Groningen, Netherlands
Leiden University Medical Center	Recruiting
Leiden, Netherlands
Contact: Evert De Jonge, Prof.
Contact e.de_jonge@lumc.nl
Canisius Wilhelmina Ziekenhuis	Recruiting
Nijmegen, Netherlands
Contact: Oscar Hoiting, M.D.
Contact O.Hoiting@cwz.nl
Radboud University Medical Center	Not yet recruiting
Nijmegen, Netherlands
Contact: Jeroen Schouten, M.D.
University Medical Center Utrecht	Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Marc Bonten, Prof. +31 88 75 573 94 M.J.M.Bonten@umcutrecht.nl
Contact: Lennie Derde, MD +31 (0)88 755 5555 L.P.G.Derde@umcutrecht.nl
New Zealand
North Shore Hospital	Recruiting
Auckland, New Zealand, 0620
Contact: Robert Everitt, MD
CVICU, Auckland City Hospital	Recruiting
Auckland, New Zealand, 1023
Contact: Shay McGuinness, MD
DCCM, Auckland City Hospital	Recruiting
Auckland, New Zealand, 1023
Contact: Colin McArthur, MD
Middlemore Hospital	Recruiting
Auckland, New Zealand, 2104
Contact: Tony Williams, MD
Christchurch Hospital	Recruiting
Christchurch, New Zealand, 4710
Contact: Seton Henderson, MD
Waikato Hospital	Recruiting
Hamilton, New Zealand, 3204
Contact: Robert Martynoga, MD
Rotorua Hospital	Recruiting
Rotorua, New Zealand, 3010
Contact: Ulrike Buehner, MD
Tauranga Hospital	Recruiting
Tauranga, New Zealand, 3112
Contact: Troy Browne, MD
Wellington Regional Hospital	Recruiting
Wellington, New Zealand, 6021
Contact: Paul Young, MD
Whangarei Hospital	Recruiting
Whangarei, New Zealand, 0148
Contact: Katherine Perry, MD
Portugal
Centro Hospitalar do Medio Tejo	Recruiting
Abrantes, Portugal
Contact: Nuno Catorze, M.D.
Contact nunocatorze@gmail.com
Hospital Lusíadas Lisbon	Not yet recruiting
Lisboa, Portugal
Contact: Nunes Nunes, M.D.
Romania
Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes"	Recruiting
Bucharest, Romania, 030303
Contact: Simin-Aysel Florescu, MD
Spain
Institut Hospital del Mar d'Investigacions Mèdiques	Not yet recruiting
Barcelona, Spain
Contact: Rosana Munoz, M.D.
Hospital Universitario Reina Sofia	Recruiting
Córdoba, Spain
Contact: Rafael Leon-Lopez, M.D.
Contact rafael.leon.lop@hotmail.com
United Kingdom
Basingstoke and North Hampshire Hospital	Not yet recruiting
Basingstoke, United Kingdom
Contact: Antony Ashton, MD
Southmead Hospital	Not yet recruiting
Bristol, United Kingdom
Contact: Matt Thomas, MD
University Hospital Coventry	Recruiting
Coventry, United Kingdom
Contact: Christopher Bassford, MD christopher.bassford@uhcw.nhs.uk
Darlington Memorial Hospital	Recruiting
Darlington, United Kingdom
Contact: James Limb, MD j.limb@nhs.net
University Hospital of North Durham	Recruiting
Durham, United Kingdom
Contact: James Limb, MD j.limb@nhs.net
Leeds Teaching Hospitals NHS Trust	Recruiting
Leeds, United Kingdom
Contact: Elankumaran Paramasivam, MD eparamasivam@nhs.net
Maidstone Hospital - Maidstone and Tunbridge Wells NHS Trust	Recruiting
Maidstone, United Kingdom
Contact: David Golden, MD david.golden@nhs.net
The James Cook University Hospital	Recruiting
Middlesbrough, United Kingdom
Contact: Jeremy Henning, MD jeremy.henning@nhs.net
Milton Keynes University Hospital	Not yet recruiting
Milton Keynes, United Kingdom
Contact: Richard Stewart, MD
Northampton General Hospital	Not yet recruiting
Northampton, United Kingdom
Contact: Jonathan Wilkinson, MD
Queen's Medical Centre - Nottingham University Hospitals NHS Trust	Recruiting
Nottingham, United Kingdom
Contact: Daniel Harvey, MD Daniel.harvey@nuh.nhs.uk
Poole Hospital NHS Foundation Trust	Recruiting
Poole, United Kingdom
Contact: Henrik Reschreiter, MD henrik.reschreiter@poole.nhs.uk
Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust	Recruiting
Portsmouth, United Kingdom
Contact: David Pogson, MD david.pogson@porthosp.nhs.uk
Royal Berkshire Hospital	Not yet recruiting
Reading, United Kingdom
Contact: Andrew Walden, MD
University Hospital of North Tees	Recruiting
Stockton-on-Tees, United Kingdom
Contact: Farooq Brohi, MD farooq.brohi@nth.nhs.uk
Royal Cornwall Hospital	Recruiting
Truro, United Kingdom
Contact: Michael Spivey, MD michaelspivey@nhs.net
Tunbridge Wells Hospital - Maidstone and Tunbridge Wells NHS Trust	Recruiting
Tunbridge Wells, United Kingdom
Contact: David Golden, MD david.golden@nhs.net
York Hospital	Not yet recruiting
York, United Kingdom
Contact: Joseph Carter, MD

Sponsors and Collaborators

MJM Bonten

Australian and New Zealand Intensive Care Research Centre

Medical Research Institute of New Zealand

Unity Health

Berry Consultants

Global Coalition for Adaptive Research

University of Pittsburgh Medical Center

Investigators

Layout table for investigator information

Study Chair:	Steve Webb, Prof	Monash University, Study Chair REMAP-CAP Australia
Study Chair:	Colin McArthur, Dr	Medical Research Institute of New Zealand, Study Chair REMAP-CAP New Zealand
Study Chair:	Marc Bonten, Prof	UMC Utrecht, Study Chair REMAP-CAP Europe
Study Chair:	Lennie Derde, MD	UMC Utrecht, Coordinating Investigator REMAP-CAP Europe
Study Chair:	Marshall Marshall, Prof	Unity Health Toronto
Study Chair:	Angus Derek, Prof	University of Pittsburgh Medical Center

More Information

Additional Information:

PREPARE website This link exits the ClinicalTrials.gov site

REMAP-CAP Study Website This link exits the ClinicalTrials.gov site

CAPTIC Website This link exits the ClinicalTrials.gov site

Protocol publication This link exits the ClinicalTrials.gov site

REMAP-CAP Protocol manuscript This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Pettilä 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 Feb 25. doi: 10.1056/NEJMoa2100433. [Epub ahead of print]

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.

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, Chassé M, Carrier FM, Boumahni D, Benettaib F, Ghamraoui A, Bellemare D, Cloutier È, 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, Đimoti R, Zapalac M, Mirković G, Baršić B, Kutleša M, Kotarski V, Vujaklija Brajković A, Babel J, Sever H, Dragija L, Kušan I, Vaara S, Pettilä L, Heinonen J, Kuitunen A, Karlsson S, Vahtera A, Kiiski H, Ristimäki 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, Schütze B, Kluge S, Nierhaus A, Jarczak D, Roedl K, Weismann D, Frey A, Klinikum Neukölln V, Reill L, Distler M, Maselli A, Bélteczki J, Magyar I, Fazekas Á, Kovács S, Szőke 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, José 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, Muñoz-Bermúdez R, Marin-Corral J, Salazar Degracia A, Parrilla Gómez F, Mateo López MI, Rodriguez Fernandez J, Cárcel Fernández S, Carmona Flores R, León López 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, Fernández 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. 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.

Layout table for additonal information

Responsible Party:	MJM Bonten, Prof. Medical Microbiology, UMC Utrecht
ClinicalTrials.gov Identifier:	NCT02735707
Other Study ID Numbers:	U1111-1189-1653 2015-002340-14 ( EudraCT Number ) 602525 ( Other Grant/Funding Number: European Union, FP7-HEALTH-2013-INNOVATION-1, PREPARE ) 16/631 ( Other Grant/Funding Number: Platform Trial Optimising Interventions in Severe Community Acquired Pneumonia Health Research Council, New Zealand) ) APP1101719 ( Other Grant/Funding Number: OPTIMISE-CAP, The National Health and Medical Research Council, Australia ) 158584 ( Other Grant/Funding Number: Canadian Institute of Health Research, Strategy for Patient-Oriented Research (CIHR- )
First Posted:	April 13, 2016 Key Record Dates
Last Update Posted:	October 12, 2020
Last Verified:	October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

Keywords provided by MJM Bonten, UMC Utrecht:


Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Anti-Bacterial Agents Moxifloxacin Levofloxacin Antibiotics Hydrocortisone Anti-Infective Agents Ceftriaxone Piperacillin-tazobactam Ceftaroline	Amoxicillin-clavulanate Oseltamivir COVID-19 Influenza Intensive care Critical care SARS-CoV-2 Vitamin C Therapeutic Anticoagulation Statin Invasive Mechanical Ventilation Convalescent plasma

Additional relevant MeSH terms:

Layout table for MeSH terms

Pneumonia Respiratory Tract Infections Respiratory Tract Diseases Lung Diseases Aspirin Interferons Ritonavir Lopinavir Oseltamivir Interferon-beta Interferon beta-1a Amoxicillin Moxifloxacin Hydroxychloroquine Levofloxacin	Tazobactam Ceftriaxone Piperacillin Clavulanic Acid Ceftaroline fosamil Amoxicillin-Potassium Clavulanate Combination Piperacillin, Tazobactam Drug Combination Apremilast Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Hydrocortisone hemisuccinate Interleukin 1 Receptor Antagonist Protein Clopidogrel Ticagrelor

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