Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Sponsors

Lead Sponsor: MJM Bonten

Collaborator: 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

Source UMC Utrecht
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.

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.

Overall Status Recruiting
Start Date 2016-04-11
Completion Date 2023-12-01
Primary Completion Date 2021-12-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
All-cause mortality Day 90
Days alive and not receiving organ support in ICU Day 21
Secondary Outcome
Measure Time Frame
ICU Mortality Day 90
ICU length of stay Day 90
Hospital length of stay Day 90
Ventilator free days Day 28
Organ failure free days Day 28
All-cause mortality 6 months
Health-related Quality of life assessment 6 months
Proportion of intubated patients who receive a tracheostomy Day 28
Destination at time of hospital discharge Free text Day 90
Readmission to the index ICU during the index hospitalization Day 90
World Health Organisation 8-point ordinal scale outcome Hospital discharge
Enrollment 7100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Fixed-duration Hydrocortisone

Description: 50mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.

Arm Group Label: Corticosteroid Domain: fixed-duration Hydrocortisone

Intervention Type: Drug

Intervention Name: Shock-dependent hydrocortisone

Description: Patient will receive 50mg IV hydrocortisone every 6 hours while the patient is in septic shock

Arm Group Label: Corticosteroid Domain: shock dependant Hydrocortisone

Intervention Type: Drug

Intervention Name: Ceftriaxone

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

Arm Group Label: Antibiotic Domain: Ceftriaxone + Macrolide

Intervention Type: Drug

Intervention Name: Moxifloxacin or Levofloxacin

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

Arm Group Label: Antibiotic Domain: Moxifloxacin or Levofloxacin

Intervention Type: Drug

Intervention Name: Piperacillin-tazobactam

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

Arm Group Label: Antibiotic Domain: Piperacillin-tazobactam + Macrolide

Intervention Type: Drug

Intervention Name: Ceftaroline

Description: 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

Arm Group Label: Antibiotic Domain: Ceftaroline + Macrolide

Intervention Type: Drug

Intervention Name: Amoxicillin-clavulanate

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

Arm Group Label: Antibiotic Domain: Amoxicillin-clavulanate + Macrolide

Intervention Type: Drug

Intervention Name: Macrolide administered for 3-5 days

Description: 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.

Arm Group Label: Macrolide Duration Domain: Standard course macrolide

Other Name: Standard course macrolide

Intervention Type: Drug

Intervention Name: Macrolide administered for up to 14 days

Description: 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.

Arm Group Label: Macrolide Duration Domain: Extended course macrolide

Other Name: Extended course macrolide

Intervention Type: Drug

Intervention Name: Five-days oseltamivir

Description: Oseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first)

Arm Group Label: Five-day course of Oseltamivir

Intervention Type: Drug

Intervention Name: Ten-days oseltamivir

Description: Oseltamivir administered enterally twice daily for 10 days or until hospital discharge (whichever occurs first)

Arm Group Label: 10-day course of oseltamivir

Intervention Type: Drug

Intervention Name: Lopinavir/ritonavir

Description: 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.

Arm Group Label: Lopinavir/ritonavir for COVID-19

Other Name: Kaletra

Intervention Type: Drug

Intervention Name: Hydroxychloroquine

Description: 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).

Arm Group Label: Hydroxychloroquine for COVID-19

Intervention Type: Drug

Intervention Name: Hydroxychloroquine + lopinavir/ritonavir

Description: 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).

Arm Group Label: Hydroxychloroquine + lopinavir/ritonavir for COVID-19

Intervention Type: Drug

Intervention Name: Interferon-β1a

Description: 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.

Arm Group Label: Interferon-β1a for COVID-19

Other Name: IFN-β1a

Intervention Type: Drug

Intervention Name: Anakinra

Description: 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.

Arm Group Label: Anakinra (interleukin-1 receptor antagonist) for COVID-19

Other Name: Interleukin-1 receptor antagonist (IL-1Ra)

Intervention Type: Drug

Intervention Name: Fixed-duration higher dose Hydrocortisone

Description: 100mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.

Arm Group Label: Fixed-duration higher dose Hydrocortisone

Intervention Type: Drug

Intervention Name: Tocilizumab

Description: 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.

Arm Group Label: Tocilizumab

Intervention Type: Drug

Intervention Name: Sarilumab

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

Arm Group Label: Sarilumab

Intervention Type: Drug

Intervention Name: Vitamin C

Description: Vitamin C 50mg/kg administered IV every 6 hours for 16 doses

Arm Group Label: Vitamin C

Intervention Type: Drug

Intervention Name: Therapeutic anticoagulation

Description: 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.

Arm Group Label: Therapeutic Anticoagulation

Intervention Type: Drug

Intervention Name: Simvastatin

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

Arm Group Label: Simvastatin

Intervention Type: Biological

Intervention Name: Convalescent plasma

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

Arm Group Label: Convalescent plasma

Intervention Type: Other

Intervention Name: Protocolised mechanical ventilation strategy

Description: See Domain Specific Appendix for a complete description of protoclised invasive mechanical ventilation strategy.

Arm Group Label: Protocolised invasive mechanical ventilation strategy

Intervention Type: Drug

Intervention Name: Eritoran

Description: 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

Arm Group Label: Eritoran

Intervention Type: Drug

Intervention Name: Apremilast

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

Arm Group Label: Apremilast

Intervention Type: Drug

Intervention Name: Aspirin

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

Arm Group Label: Aspirin

Other Name: acetylsalicylic acid

Intervention Type: Drug

Intervention Name: Clopidogrel

Description: Clopidogrel administered 75 mg once per day for 14 days or until hospital discharge, whichever occurs first.

Arm Group Label: P2Y12 inhibitor

Intervention Type: Drug

Intervention Name: Prasugrel

Description: 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.

Arm Group Label: P2Y12 inhibitor

Intervention Type: Drug

Intervention Name: Ticagrelor

Description: Ticagrelor administered enterally at 60mg twice daily for 14 days or until hospital discharge, whichever occurs first.

Arm Group Label: P2Y12 inhibitor

Eligibility

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).

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Cameron Green

Email: [email protected]

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

Australia

Belgium

Canada

Croatia

Germany

Hungary

Ireland

Netherlands

New Zealand

Portugal

Romania

Spain

United Kingdom

United States

Verification Date

2020-10-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: UMC Utrecht

Investigator Full Name: MJM Bonten

Investigator Title: Prof. Medical Microbiology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 38
Arm Group

Label: Corticosteroid Domain: fixed-duration Hydrocortisone

Type: Active Comparator

Description: The patient will receive IV Hydrocortisone 50 mg every 6 hours for up to 7 days.

Label: Corticosteroid Domain:No systemic corticosteroid (no placebo)

Type: No Intervention

Description: The patient will receive no systemic corticosteroid for the treatment of CAP or its direct complications, up until study day 28.

Label: Corticosteroid Domain: shock dependant Hydrocortisone

Type: Active Comparator

Description: The patient will receive hydrocortisone (50mg IV every 6 hours) while the patient is in septic shock.

Label: Antibiotic Domain: Ceftriaxone + Macrolide

Type: Active Comparator

Description: Ceftriaxone and site preferred macrolide will be administered for empiric antibiotic therapy

Label: Antibiotic Domain: Moxifloxacin or Levofloxacin

Type: Active Comparator

Description: Moxifloxacin or levofloxacin will be administered for empiric antibiotic therapy

Label: Antibiotic Domain: Piperacillin-tazobactam + Macrolide

Type: Active Comparator

Description: Piperacillin-tazobactam and site preferred macrolide will be administered for empiric antibiotic therapy

Label: Antibiotic Domain: Ceftaroline + Macrolide

Type: Active Comparator

Description: Ceftaroline and site preferred macrolide will be administered for empiric antibiotic therapy

Label: Antibiotic Domain: Amoxicillin-clavulanate + Macrolide

Type: Active Comparator

Description: Amoxicillin-clavunate and site preferred macrolide will be administered for empiric antibiotic therapy

Label: Macrolide Duration Domain: Standard course macrolide

Type: Active Comparator

Description: The patient will receive macrolide therapy for 3-5 days. This arm is nested within the Antibiotic Domain.

Label: Macrolide Duration Domain: Extended course macrolide

Type: Active Comparator

Description: The patient will receive macrolide therapy for up to 14 days. This arm is nested within the Antibiotic Domain.

Label: No antiviral agent active against influenza (no placebo)

Type: No Intervention

Description: The patient will receive no antiviral agent active against influenza, including oseltamivir.

Label: Five-day course of Oseltamivir

Type: Active Comparator

Description: The patient will receive a five-day course of oseltamivir.

Label: 10-day course of oseltamivir

Type: Active Comparator

Description: The patient will receive a ten-day course of oseltamivir.

Label: No antiviral for COVID-19

Type: No Intervention

Description: The patient will receive no antiviral agent intended to be active against SARS-CoV-2 infection.

Label: Lopinavir/ritonavir for COVID-19

Type: Active Comparator

Description: Patients will receive lopinavir/ritonavir (kaletra) 400/100mg enterally every 12 hours intended to be active against SARS-CoV-2 infection.

Label: Hydroxychloroquine for COVID-19

Type: Active Comparator

Description: Patients will receive hydroxychloroquine intended to be active against SARS-CoV-2 infection.

Label: Hydroxychloroquine + lopinavir/ritonavir for COVID-19

Type: Active Comparator

Description: Patients will receive both hydroxychloroquine and lopinavir/ritonavir intended to be active against SARS-CoV-2 infection.

Label: No immune modulation for COVID-19

Type: No Intervention

Description: Patients will not receive any immune modulating therapy intended to be active against COVID-19.

Label: Interferon-β1a for COVID-19

Type: Active Comparator

Description: Patients will receive Interferon-β1a intended to be active against COVID-19.

Label: Anakinra (interleukin-1 receptor antagonist) for COVID-19

Type: Active Comparator

Description: Patients will receive anakinra intended to be active against COVID-19.

Label: Fixed-duration higher dose Hydrocortisone

Type: Active Comparator

Description: The patient will receive IV Hydrocortisone 100mg every 6 hours for up to 7 days.

Label: Tocilizumab

Type: Active Comparator

Description: Patients will receive Tocilizumab intended to be active against COVID-19

Label: Sarilumab

Type: Active Comparator

Description: Patients will receive Sarilumab intended to be active against COVID-19

Label: No Vitamin C

Type: No Intervention

Description: Patients will not receive vitamin c (no placebo)

Label: Vitamin C

Type: Active Comparator

Description: Patients will receive IV Vitamin C (50mg/kg every 6 hours for 16 doses)

Label: Standard Care Thromboprophylaxis

Type: No Intervention

Description: Patients will receive local standard care thromboprophylaxis for 14 days.

Label: Therapeutic Anticoagulation

Type: Active Comparator

Description: Therapeutic anticoagulation with IV unfractionated heparin or subcutaneous low molecular weight heparin.

Label: No simvastatin

Type: No Intervention

Description: Patients will not receive simvastatin for up to 28 days while the patient remains in hospital.

Label: Simvastatin

Type: Active Comparator

Description: Patients will receive simvastatin (80mg enterally once daily) for up to 28 days while the patient remains in hospital.

Label: No immunoglobulin against SARS-CoV-2

Type: No Intervention

Description: Patients will not receive any preparation of immunoglobulin intended to neutralise SARS-CoV-2 during the index hospitalisation.

Label: Convalescent plasma

Type: Active Comparator

Description: Patients will receive at least one, and not more than two, units of convalescent plasma within 48 hours of randomisation.

Label: Clinician-preferred invasive ventilation

Type: No Intervention

Description: Patients will receive invasive mechanical ventilation as determined by the treating clinician.

Label: Protocolised invasive mechanical ventilation strategy

Type: Active Comparator

Description: Patient will receive a protocolised invasive mechanical ventilation strategy

Label: Eritoran

Type: Active Comparator

Description: Patients will receive Eritoran intended to be active against COVID-19

Label: Apremilast

Type: Active Comparator

Description: Patients will receive Apremilast intended to be active against COVID-19

Label: No antiplatelet

Type: No Intervention

Description: Patients will not receive any antiplatelet agent or NSAID for 14 days while patient remains in hospital

Label: Aspirin

Type: Active Comparator

Description: Patients will receive aspirin for up to 14 days while the patient remains in hospital

Label: P2Y12 inhibitor

Type: Active Comparator

Description: Patients will receive either clopidogrel, prasugrel, or ticagrelor (as per site preference).

Acronym REMAP-CAP
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Factorial Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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