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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 : June 5, 2023
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
Intensive Care National Audit & Research Centre
St. Marianna University School of Medicine
National Intensive Care Surveillance MORU
Information provided by (Responsible Party):
Lennie Derde, UMC Utrecht

Study Description
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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.


Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia, Influenza, COVID-19 Drug: Ceftriaxone Drug: Moxifloxacin or Levofloxacin Drug: Piperacillin-tazobactam Drug: Ceftaroline Drug: Amoxicillin-clavulanate Drug: Standard course macrolide Drug: Extended course macrolide Other: No systemic corticosteroid Drug: Fixed-duration Hydrocortisone Drug: Shock-dependent hydrocortisone Drug: Fixed-duration higher dose Hydrocortisone Other: No antiviral agent for influenza Drug: Five-days oseltamivir Drug: Ten-days oseltamivir Other: No antiviral agent for COVID-19 Drug: Lopinavir / Ritonavir Drug: Hydroxychloroquine Drug: Hydroxychloroquine + lopinavir/ritonavir Drug: Ivermectin Other: No immune modulation for COVID-19 Drug: Interferon beta-1a Drug: Anakinra Drug: Tocilizumab Drug: Sarilumab Drug: Local standard venous thromboprophylaxis Drug: Therapeutic dose anticoagulation Drug: Conventional low dose thromboprophylaxis Drug: Intermediate dose thromboprophylaxis Drug: Continuation of therapeutic dose anticoagulation Other: No immunoglobulin Biological: Convalescent plasma Biological: Delayed administration of convalescent plasma Other: No vitamin C Drug: Vitamin C Other: No antiplatelet Drug: Aspirin Drug: P2Y12 inhibitor Other: No simvastatin Drug: Simvastatin Other: Placebo Drug: Eritoran Drug: Apremilast Procedure: Clinician-preferred mechanical ventilation strategy Procedure: Protocolised mechanical ventilation strategy Other: No renin-angiotensin system inhibitor Drug: Angiotensin converting enzyme inhibitor Drug: Angiotensin Receptor Blockers Drug: ARB + DMX-200 Other: No cysteamine Drug: Cysteamine Drug: Fixed-duration dexamethasone Drug: Baloxavir Marboxil Drug: Five-days oseltamivir + baloxavir marboxil Drug: Ten-days oseltamivir + baloxavir marboxil Other: No endothelial modulator Drug: Imatinib Phase 3

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 : 10000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Adaptive Bayesian Platform Trial evaluating multiple interventions in multiple domains
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 : February 2026
Estimated Study Completion Date : February 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.

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

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

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

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

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

Drug: 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.
Corticosteroid Domain

Patients with community acquired pneumonia (CAP) admitted to participating intensive care units 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.

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

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

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

Drug: 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.


Drug: Fixed-duration dexamethasone
6 mg of IV or enteral dexamethasone will be administered daily for up to 10 days while in hospital.
Influenza Antiviral Domain
Patients with community-acquired pneumonia admitted to participating intensive care units with microbiological testing confirmed influenza infection will be randomised to one of six interventions.
 Other: No antiviral agent for influenza
No antiviral agent intended to be active against influenza infection is to be administered

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

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

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

Drug: 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.

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

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.

Note: this intervention is now closed.


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).

Note: this intervention is now closed.


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).

Note: this intervention is now closed.


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


Drug: Interferon beta-1a

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.

Note: this intervention is now closed.

Other Name: IFN-β1a

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 every 6 hours.

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

Note: this intervention is now closed.


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.

Note: this intervention is now closed.

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


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.

Note: this intervention is now closed.
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.

 Drug: 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.


Drug: 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.


Drug: 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.

Drug: 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.

Drug: 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.
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: No immunoglobulin

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

Note: this intervention is now closed.


Biological: Convalescent plasma

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

Note: this intervention is now closed.


Biological: Delayed administration of convalescent plasma
Note: this intervention is now closed.
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: No vitamin C
No high dose intravenous vitamin C is to be administered

Drug: Vitamin C
Intravenous Vitamin C 50mg/kg administered every 6 hours for 16 doses
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: No simvastatin
No simvastatin intended to be active against COVID-19 is to be administered

Drug: Simvastatin
Simvastatin 80mg administered once daily via enteral route, while the patient remains in hospital up to 28 days after randomisation
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.
 Other: No antiplatelet

No antiplatelet agent or NSAID to be administered.

Note: this intervention is now closed.


Drug: 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.

Other Name: acetylsalicylic acid

Drug: 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 Names:
  • Clopidogrel
  • Prasugrel
  • Ticagrelor
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
 Procedure: Clinician-preferred mechanical ventilation strategy
Clinician-preferred ventilation strategy, including mode of ventilation and all ventilatory parameters

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

Drug: Apremilast

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

Note: this intervention is now closed.
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: 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.

Drug: 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.
Other Names:
  • Ramipril
  • Lisinopril
  • Perindopril
  • Enalapril
  • Trandolapril
  • Captopril

Drug: Angiotensin Receptor Blockers
Site-preferred ARB agent administered as directed by the treating clinician for 10 days or until hospital discharge, whichever occurs first.
Other Names:
  • Losartan
  • Valsartan
  • Candesartan
  • Irbesartan
  • Telmisartan
  • Olmesartan

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

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

Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: Day 90 ]
  2. 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 :
  1. ICU Mortality [ Time Frame: Day 90 ]
  2. ICU length of stay [ Time Frame: Day 90 ]
  3. Hospital length of stay [ Time Frame: Day 90 ]
  4. Ventilator free days [ Time Frame: Day 28 ]
  5. Organ failure free days [ Time Frame: Day 28 ]
  6. All-cause mortality [ Time Frame: 6 months ]
  7. Health-related Quality of life assessment [ Time Frame: 6 months ]
    EQ5D-5L and WHODAS 2.0 (not completed in all regions)

  8. Proportion of intubated patients who receive a tracheostomy [ Time Frame: Day 28 ]
  9. 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

  10. Readmission to the index ICU during the index hospitalization [ Time Frame: Day 90 ]
  11. World Health Organisation 8-point ordinal scale outcome [ Time Frame: Hospital discharge ]

Other Outcome Measures:
  1. Occurrence of multi-resistant organism colonisation/infection [ Time Frame: Day 90, censored at hospital discharge ]
    Antibiotic Domain specific outcome

  2. Occurrence clostridium difficile [ Time Frame: Day 90, censored at hospital discharge ]
    Antibiotic Domain specific outcome

  3. 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.

  4. 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.

  5. Confirmed deep vein thrombosis [ Time Frame: Between randomisation and hospital discharge ]
    Domain-specific outcome for Anticoagulation, Immunoglobulin, and Antiplatelet Domains.

  6. Confirmed pulmonary embolism [ Time Frame: Between randomisation and hospital discharge ]
    Domain-specific outcome for Anticoagulation, Immunoglobulin, and Antiplatelet Domains.

  7. Confirmed ischaemic cerebrovascular event [ Time Frame: Between randomisation and hospital discharge ]
    Domain-specific outcome for Anticoagulation, Immunoglobulin, and Antiplatelet Domains.

  8. Total red blood cell units transfused [ Time Frame: Between randomisation and end of study day 15 ]
    Domain-specific outcome for Anticoagulation and Antiplatelet Domains.

  9. Confirmed acute myocardial infarction [ Time Frame: Between randomisation and hospital discharge ]
    Domain-specific outcome for Anticoagulation, Immunoglobulin, and Antiplatelet Domains.

  10. Peak troponin [ Time Frame: Between randomisation and end of study day 15 ]
    Domain-specific outcome for Anticoagulation and Antiplatelet Domains.

  11. Major bleeding event [ Time Frame: Between randomisation and end of study day 15 ]
    Domain-specific outcome for Anticoagulation and Antiplatelet Domains.

  12. Other confirmed thrombotic event, including mesenteric ischaemia and limb ischaemia [ Time Frame: Between randomisation and hospital discharge ]
    Domain-specific outcome for Anticoagulation, Immunoglobulin, and Antiplatelet Domains.

  13. Acute kidney injury (KDIGO stage >= 2 acute kidney injury) [ Time Frame: Between randomisation and 7 days ]
    Domain-specific outcome for ACE2 RAS Domain

  14. Change from baseline to peak creatinine [ Time Frame: Between randomisation and 14 days ]
    Domain-specific outcome for ACE2 RAS Domain

  15. Angioedema [ Time Frame: Between randomisation and end of study day 12 ]
    Domain-specific outcome for ACE2 RAS Domain

  16. Change from baseline AST, ALT and bilirubin [ Time Frame: Between randomisation and 14 days ]
    Domain-specific outcome for ACE2 RAS Domain


Eligibility Criteria
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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.


Layout table for eligibility information
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:

  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).

Contacts and Locations
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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
Layout table for location contacts
Contact: Cameron Green, MSc info@remapcap.org
Contact: Svenja Peters, MSc EU.remapcap@umcutrecht.nl

Locations
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Sponsors and Collaborators
UMC Utrecht
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
Intensive Care National Audit & Research Centre
St. Marianna University School of Medicine
National Intensive Care Surveillance MORU
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: John Marshall, Prof Unity Health Toronto, Study Chair REMAP-CAP Canada
Study Chair: Derek Angus, Prof University of Pittsburgh Medical Center, Study Chair REMAP-CAP USA
More Information
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Additional Information:

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

Layout table for additonal information
Responsible Party: Lennie Derde, Dr., 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: Health Research Council of New Zealand )
APP1101719 ( Other Grant/Funding Number: National Health and Medical Research Council, Australia )
158584 ( Other Grant/Funding Number: Canadian Institute of Health Research )
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: June 5, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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 Lennie Derde, 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
Eritoran
Apremilast
DMX-200
Ivermectin
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Pneumonia, Viral
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Aspirin
Vitamins
Ascorbic Acid
 Interferons
Ritonavir
Lopinavir
Interferon-beta
Oseltamivir
Interferon beta-1a
Antiviral Agents
Baloxavir
Amoxicillin
Moxifloxacin
Hydroxychloroquine
Levofloxacin
Ivermectin
Ceftriaxone
Tazobactam