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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 28 May 2020

At a glance

  • Drugs Anakinra (Primary) ; Hydroxychloroquine (Primary) ; Interferon beta-1a (Primary) ; Lopinavir/ritonavir (Primary) ; Sarilumab (Primary) ; Tocilizumab (Primary) ; Amoxicillin; Azithromycin; Ceftaroline fosamil; Ceftriaxone; Clarithromycin; Erythromycin; Hydrocortisone; Interferon beta-1; Levofloxacin; Macrolides; Moxifloxacin; Oseltamivir; Piperacillin/tazobactam; Roxithromycin
  • Indications Community-acquired pneumonia; COVID 2019 infections; Influenza virus infections
  • Focus Therapeutic Use
  • Acronyms AD-SCAP; REMAP-CAP
  • Most Recent Events

    • 27 Apr 2020 According to a Faron Pharmaceuticals media release, this trial is underway more than 60 sites and 13 countries (announced on 01 April 2020).
    • 15 Apr 2020 Planned number of patients changed from 6800 to 7100.
    • 15 Apr 2020 Planned End Date changed from 1 Jun 2022 to 1 Dec 2023.

Trial Overview

Purpose

The study will, therefore, compare directly the treatment effect of Faron's investigational IV IFN beta-1a, hydrocortisone treatments, and other study treatment options on the clinical outcomes of COVID-19 patients and those with other causes of pneumonia requiring ICU care.

Primary Endpoints

All-cause mortality

time_frame: Day 90

Days alive and outside of ICU

description: Primary end-point for patients with suspected or proven COVID-19 pandemic infection
time_frame: Day 21

The primary objective of this REMAP is, for adult patients with severe CAP who are admitted to an ICU, to identify the effect of a range of interventions to improve outcome as defined by all-cause mortality at 90 days.
Timepoint: 90 Days from the date of enrolment.

Other Endpoints

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

Health-related Quality of life assessment

description: EQ5D-5L and WHODAS 2.0 (not completed in all regions) time_frame: 6 months

Proportion of intubated patients who receive a tracheostomy

time_frame: Day 28

Destination at time of hospital discharge

description: Characterised as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital time_frame: Free text Day 90

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

Occurrence of multi-resistant organism colonisation/infection

description: Antibiotic Domain specific outcome time_frame: Day 90, censored at hospital discharge

Occurrence clostridium difficile

description: Antibiotic Domain specific outcome time_frame: Day 90, censored at hospital discharge

Occurrence of serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death

description: Macrolide Duration domain specific outcome, and COVID-19 Antiviral Domain specific outcome. time_frame: Day 90, censored at hospital discharge

Change from baseline influenza virus levels in upper and lower respiratory tract specimens

description: Antiviral Domain specific outcome. Only required at selected sites. time_frame: Day 3, up to Day 7

Serial detection of SARS-CoV-2 in upper or lower respiratory tract specimens (using only specimens collected for routine clinical testing)

description: COVID-19 Antiviral Domain and COVID-19 Immune Modulation Domain specific endpoint time_frame: Day 90, censored at hospital discharge [1]

Diseases Treated

Indication Qualifiers Patient Segments
Community-acquired pneumonia treatment severe
COVID 2019 infections treatment -
Influenza virus infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 7100

  • Sex male & female
  • Age Group ≥ 18 years; adult; elderly

Patient Inclusion Criteria

REMAP-CAP PLATFORM 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

Patient 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) hospitalised with suspected or proven COVID-19 infection. "Suspected COVID-19 infection" means the patient is clinically diagnosed based on symptoms and/or exposure and for whom a microbiology test for COVID-19 has been/will be ordered, but for whom the result is pending. "Proven COVID-19 infection" means the patient has a confirmed positive result for COVID-19 based on microbiological testing. ADDITIONAL PLATFORM INCLUSION CRITERIA FOR ICU-BASED REMAP-COVID DOMAINS 1. Admitted to an ICU with the following features suggestive of COVID-19-related pneumonia: 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 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. 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).

Trial Details

Identifiers

Identifier Owner
NCT02735707 ClinicalTrials.gov: US National Institutes of Health
EudraCT2015-002340-14 European Clinical Trials Database
U1111-1189-1653 World Health Organisation
AD-SCAP -
602525 -
REMAP-CAP -
16-631 -
APP1101719 -
158584 -

Organisations

  • Affiliations Faron Pharmaceuticals

Trial Dates

  • Initiation Dates

    Actual : 11 Apr 2016

  • Primary Completion Dates

    Planned : 01 Dec 2021

  • End Dates

    Planned : 01 Dec 2023

Other Details

  • Design multicentre; open; prospective; randomised
  • Phase of Trial Phase IV
  • Location Australia; Belgium; Canada; Croatia; Czech Republic; Denmark; England; Finland; France; Germany; Greece; Hungary; Ireland; Netherlands; New Zealand; Portugal; Romania; Spain; United Kingdom
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
Amoxicillin Intravenous
-
AnakinraPrimary Drug Intravenous Infusion
Azithromycin Intravenous Infusion
Ceftaroline fosamil Intravenous
-
Ceftriaxone Intravenous Infusion, Injection
Clarithromycin Intravenous Infusion
Erythromycin Intravenous Infusion
Hydrocortisone Intravenous Infusion, Injection
HydroxychloroquinePrimary Drug Enteral
-
Interferon beta-1 Intravenous Injection
Interferon beta-1aPrimary Drug Intravenous Injection
Levofloxacin Intravenous Infusion
Lopinavir/ritonavirPrimary Drug Enteral Tablet
Macrolides
-
-
Moxifloxacin Intravenous Infusion
Oseltamivir Enteral Capsule
Piperacillin/tazobactam
-
-
Roxithromycin Enteral
-
SarilumabPrimary Drug Intravenous Infusion
TocilizumabPrimary Drug Intravenous Infusion

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.)

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)

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.)

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.)

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.)

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)

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.)

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

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

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))

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))

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

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).)

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).)

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

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)

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.)

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.)

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.)

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.

No antiviral agent active against influenza (no placebo)

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

No antiviral for COVID-19

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

No immune modulation for COVID-19

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

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
-
Canisius Wilhelmina Ziekenhuis, Centro Hospitalar do Medio Tejo, Hospital Universitario Reina Sofia, Leiden University Medical Center, St. Vincent's University Hospital Ireland, Netherlands, Portugal, Spain
Ana Vujaklija Brajković, MD University Hospital Centre Zagreb Croatia
Andrew Walden, MD Royal Berkshire Hospital United-Kingdom
André Finn, MD Charité - Universitätsmedizin Berlin - Nephrologie Germany
Angus Derek, Prof University of Pittsburgh Medical Center
-
Antony Ashton, MD Basingstoke and North Hampshire Hospital United-Kingdom
Bruno Barsić, MD University Hospital for Infectious Diseases Croatia
Béla Gál, MD Csolnoky Ferenc Kórház - Veszprem County Hospital Hungary
Cameron Green
info@remapcap.org
show details
-
Christopher Bassford, MD
christopher.bassford@uhcw.nhs.uk
show details
University Hospital Coventry United-Kingdom
Colin McArthur, Dr Medical Research Institute of New Zealand, Study Chair REMAP-CAP New Zealand
-
Colin McArthur, MD DCCM, Auckland City Hospital New-Zealand
Daniel Harvey, MD
Daniel.harvey@nuh.nhs.uk
show details
Queen's Medical Centre - Nottingham University Hospitals NHS Trust United-Kingdom
David Golden, MD
david.golden@nhs.net
show details
Maidstone Hospital - Maidstone and Tunbridge Wells NHS Trust, Tunbridge Wells Hospital - Maidstone and Tunbridge Wells NHS Trust United-Kingdom
David Pogson, MD
david.pogson@porthosp.nhs.uk
show details
Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust United-Kingdom
Deborah Cook, MD St. Joseph's Healthcare Hamilton Canada
Dirk Weismann, MD Universitätsklinikum Würzburg Germany
Elankumaran Paramasivam, MD
eparamasivam@nhs.net
show details
Leeds Teaching Hospitals NHS Trust United-Kingdom
Farooq Brohi, MD
farooq.brohi@nth.nhs.uk
show details
University Hospital of North Tees United-Kingdom
Francois Lamontagne, MD Centre Hospitalier de l'Université de Sherbrooke Canada
Ger Curley, Prof. Beaumont Hospital Ireland
Gernot Rohde, Prof. Dr. Universitätsklinikum Frankfurt Germany
Gábor Szigligeti, MD Jósa András County Hospital Hungary
Henrik Reschreiter, MD
henrik.reschreiter@poole.nhs.uk
show details
Poole Hospital NHS Foundation Trust United-Kingdom
James Limb, MD
j.limb@nhs.net
show details
Darlington Memorial Hospital, University Hospital of North Durham United-Kingdom
Jeremy Henning, MD
jeremy.henning@nhs.net
show details
The James Cook University Hospital United-Kingdom
Jeroen Schouten, M.D. Radboud University Medical Center Netherlands
John Laffey, M.D. University Hospital Galway Ireland
John Marshall, MD St. Michael's Hospital Unity Health Toronto Canada
Jonathan Wilkinson, MD Northampton General Hospital United-Kingdom
Joseph Carter, MD York Hospital United-Kingdom
Julius Centrum UMCU
Universiteitsweg 100
Utrecht
Postcode: 3584
Netherlands
Telephone: +31(0)8875 681 81
juliuscenter@umcutrecht.nl
show details
University Medical Center Utrecht Netherlands
János Bélteczki, MD Almási Balogh Pál Kórház Hungary
Katherine Perry, MD Whangarei Hospital New-Zealand
Koen Simons, M.D. Jeroen Bosch Ziekenhuis Netherlands
Lars Pester Universitätsklinikum Köln Germany
Laura van Gulik, M.D. Meander Medisch Centrum Netherlands
Lennie Derde, MD
+31 (0)88 755 5555 L.P.G.Derde@umcutrecht.nl
show details
University Medical Center Utrecht Netherlands
Lorenz Reill, MD Vivantes Klinikum Neukölln Germany
Marc Bonten, Prof UMC Utrecht, Study Chair REMAP-CAP Europe
-
Marc Bourgeois, MD AZ Sint-Jan Belgium
Marshall Marshall, Prof Unity Health Toronto
-
Martin Witzenrath, Prof. Dr. Charité - Universitätsmedizin Berlin - Infektiologie und Pneumologie Germany
Mathias W. Pletz, Prof. Dr.
mathias.pletz@med.uni-jena.de
show details
Universitätsklinikum Jena Germany
Matt Thomas, MD Southmead Hospital United-Kingdom
Michael Spivey, MD
michaelspivey@nhs.net
show details
Royal Cornwall Hospital United-Kingdom
Nunes Nunes, M.D. Hospital Lusíadas Lisbon Portugal
Patrick Biston, MD CHU de Charleroi - Hôpital Civil Marie Curie Belgium
Paul Young, MD Wellington Regional Hospital New-Zealand
Philippe Jorens, Prof. Universitair Ziekenhuis Antwerp Belgium
Pieter Depuydt, Prof.
Pieter.Depuydt@UGent.be
show details
Universitair Ziekenhuis Gent Belgium
Richard Stewart, MD Milton Keynes University Hospital United-Kingdom
Robert Everitt, MD North Shore Hospital New-Zealand
Robert Martynoga, MD Waikato Hospital New-Zealand
Rosana Munoz, M.D. Institut Hospital del Mar d'Investigacions Mèdiques Spain
Sascha David, MD Medizinische Hochschule Hannover Germany
Seton Henderson, MD Christchurch Hospital New-Zealand
Shay McGuinness, MD CVICU, Auckland City Hospital New-Zealand
Simin-Aysel Florescu, MD Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes" Romania
Sirak Petros, Prof. Dr.
Sirak.Petros@uniklinik-leipzig.de
show details
Universitätsklinikum Leipzig Germany
Siri Göpel, MD Universitäts Klinikum Tübingen Germany
Stefan Klug, Prof. Dr. University Medical Center Hamburg-Eppendorf (UKE) Germany
Steve Webb, Prof Monash University, Study Chair REMAP-CAP Australia
-
Tony Williams, MD Middlemore Hospital New-Zealand
Troy Browne, MD Tauranga Hospital New-Zealand
Ulrike Buehner, MD Rotorua Hospital New-Zealand
Wilma Van Bentum-Puijk, MSc
+31 (0) 88 755 5555 prepare_icu@umcutrecht.nl
show details
-
Zdravko Andrić, MD General County Hospital Požega Croatia

Centres

Centre Name Location Trial Centre Country
-
-
-
Almási Balogh Pál Kórház Ózd Hungary
Australian and New Zealand Intensive Care Research Centre
-
-
AZ Sint-Jan Brugge Belgium
Basingstoke and North Hampshire Hospital Basingstoke United-Kingdom
Beaumont Hospital Dublin Ireland
Bendigo Hospital Bendigo, Victoria Australia
Berry Consultants
-
-
Canisius Wilhelmina Ziekenhuis Nijmegen Netherlands
Centre Hospitalier de l'Université de Sherbrooke Sherbrooke Canada
Centro Hospitalar do Medio Tejo Abrantes Portugal
Charité - Universitätsmedizin Berlin - Infektiologie und Pneumologie Berlin Germany
Charité - Universitätsmedizin Berlin - Nephrologie Berlin Germany
Christchurch Hospital Christchurch New-Zealand
CHU de Charleroi - Hôpital Civil Marie Curie Charleroi Belgium
Clinical Hospital of Infectious and Tropical Diseases "Dr. Victor Babes" Bucharest Romania
Csolnoky Ferenc Kórház - Veszprem County Hospital Veszprém Hungary
CVICU, Auckland City Hospital Auckland New-Zealand
Darlington Memorial Hospital Darlington United-Kingdom
DCCM, Auckland City Hospital Auckland New-Zealand
Fiona Stanley Hospital Perth, Western Australia Australia
FP7-HEALTH-2013-INNOVATION-1
-
European-Union
General County Hospital Požega Požega Croatia
Global Coalition for Adaptive Research
-
-
Hospital Lusíadas Lisbon Lisboa Portugal
Hospital Universitario Reina Sofia Córdoba Spain
Institut Hospital del Mar d'Investigacions Mèdiques Barcelona Spain
Jeroen Bosch Ziekenhuis Den Bosch Netherlands
Jósa András County Hospital Nyíregyháza Hungary
Leeds Teaching Hospitals NHS Trust Leeds United-Kingdom
Leiden University Medical Center Leiden Netherlands
Logan Hospital Brisbane, Queensland Australia
Maidstone Hospital - Maidstone and Tunbridge Wells NHS Trust Maidstone United-Kingdom
Martini Hospital Groningen Groningen Netherlands
Meander Medisch Centrum Amersfoort Netherlands
Medical Research Institute of New Zealand
-
-
Medical Research Institute of New Zealand, Study Chair REMAP-CAP New Zealand
-
-
Medizinische Hochschule Hannover Hannover Germany
Middlemore Hospital Auckland New-Zealand
Milton Keynes University Hospital Milton Keynes United-Kingdom
MJM Bonten
-
-
Monash University, Study Chair REMAP-CAP Australia
-
-
Nepean Hospital Sydney, New South Wales Australia
North Shore Hospital Auckland New-Zealand
Northampton General Hospital Northampton United-Kingdom
Poole Hospital NHS Foundation Trust Poole United-Kingdom
Princess Alexandra Hospital Brisbane, Queensland Australia
Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust Portsmouth United-Kingdom
Queen's Medical Centre - Nottingham University Hospitals NHS Trust Nottingham United-Kingdom
Radboud University Medical Center Nijmegen Netherlands
Rotorua Hospital Rotorua New-Zealand
Royal Berkshire Hospital Reading United-Kingdom
Royal Cornwall Hospital Truro United-Kingdom
Royal Darwin Hospital, Darwin, Northern Territory Australia
Royal Melbourne Hospital Melbourne, Victoria Australia
Royal North Shore Hospital Sydney, New South Wales Australia
Royal Perth Hospital Perth, Western Australia Australia
Royal Prince Alfred Hospital Sydney, New South Wales Australia
Sir Charles Gairdner Hospital Perth, Western Australia Australia
Southmead Hospital Bristol United-Kingdom
St John of God Hospital Midland Perth, Western Australia Australia
St John of God Hospital Murdoch Perth, Western Australia Australia
St Vincent's Hospital Melbourne Melbourne, Victoria Australia
St Vincent's Hospital Sydney Sydney, New South Wales Australia
St. Joseph's Healthcare Hamilton Hamilton Canada
St. Michael's Hospital Unity Health Toronto Toronto Canada
St. Vincent's University Hospital Dublin Ireland
Sunshine Coast University Hospital Birtinya, Queensland Australia
Tauranga Hospital Tauranga New-Zealand
The Alfred Hospital Melbourne, Victoria Australia
The James Cook University Hospital Middlesbrough United-Kingdom
The Queen Elizabeth Hospital Adelaide, South Australia Australia
Toowoomba Hospital Toowoomba, Queensland Australia
Tunbridge Wells Hospital - Maidstone and Tunbridge Wells NHS Trust Tunbridge Wells United-Kingdom
UMC Utrecht, Study Chair REMAP-CAP Europe
-
-
Unity Health
-
-
Unity Health Toronto
-
-
Universitair Ziekenhuis Antwerp Edegem Belgium
Universitair Ziekenhuis Gent Gent Belgium
University Hospital Centre Zagreb Zagreb Croatia
University Hospital Coventry Coventry United-Kingdom
University Hospital for Infectious Diseases Zagreb Croatia
University Hospital Galway Galway Ireland
University Hospital of North Durham Durham United-Kingdom
University Hospital of North Tees Stockton-on-Tees United-Kingdom
University Hosptial Geelong Geelong, Victoria Australia
University Medical Center Groningen Groningen Netherlands
University Medical Center Hamburg-Eppendorf (UKE) Hamburg Germany
University Medical Center Utrecht Utrecht Netherlands
University Medical Center Utrecht Utrecht Netherlands
University of Pittsburgh Medical Center
-
-
Universitäts Klinikum Tübingen Tübingen Germany
Universitätsklinikum Frankfurt Frankfurt Germany
Universitätsklinikum Jena Jena Germany
Universitätsklinikum Köln Cologne Germany
Universitätsklinikum Leipzig Leipzig Germany
Universitätsklinikum Würzburg Würzburg Germany
Vivantes Klinikum Neukölln Berlin Germany
Waikato Hospital Hamilton New-Zealand
Wellington Regional Hospital Wellington New-Zealand
Whangarei Hospital Whangarei New-Zealand
Wollongong Hospital Sydney, New South Wales Australia
York Hospital York United-Kingdom

Trial History

Event Date Event Type Comment
28 May 2020 Other trial event Last checked against European Clinical Trials Database record. Updated 28 May 2020
27 Apr 2020 Other trial event According to a Faron Pharmaceuticals media release, this trial is underway more than 60 sites and 13 countries (announced on 01 April 2020). Updated 04 May 2020
17 Apr 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 17 Apr 2020
15 Apr 2020 Other trial event Planned number of patients changed from 6800 to 7100. Updated 17 Apr 2020
15 Apr 2020 Completion date Planned End Date changed from 1 Jun 2022 to 1 Dec 2023. Updated 17 Apr 2020
01 Apr 2020 Other trial event According to a Faron Pharmaceuticals media release, this study is supported by several funding agencies all over the world. Updated 06 Apr 2020
16 Aug 2018 Completion date Planned End Date changed from 1 Feb 2019 to 1 Jun 2022. Updated 27 Aug 2018
16 Aug 2018 Other trial event Planned primary completion date changed from 1 Feb 2019 to 1 Dec 2021. Updated 27 Aug 2018
03 Aug 2018 Other trial event Planned number of patients changed from 4000 to 6800. Updated 08 Aug 2018
15 Apr 2016 Other trial event New source identified and integrated (ClinicalTrials.gov NCT02735707). Updated 15 Apr 2016
09 Oct 2015 New trial record New trial record Updated 09 Oct 2015

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  3. Faron Pharmaceuticals. REMAP-CAP to study IFN beta-1a effect in COVID-19. Media-Rel 2020;.

    Media Release
  4. Faron Pharmaceuticals. Traumakine to be a part of WHO's Solidarity trial investigating potential COVID-19 treatments. Media-Rel 2020;.

    Media Release
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