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Multiple Treatments for Pneumonia (REMAP-CAP Trial)

Phase 3
Recruiting
Research Sponsored by MJM Bonten
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
symptoms or signs or both that are consistent with lower respiratory tract infection
Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission with symptoms or signs or both that are consistent with lower respiratory tract infection
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

This trial is looking at different ways to improve the outcome of patients with community-acquired pneumonia who are admitted to the intensive care unit.

Who is the study for?
This trial is for adults in ICU with severe community-acquired pneumonia, needing ventilators or vasopressors within 48 hours of hospital admission. It's also for those admitted with suspected or proven pandemic infection showing lower respiratory symptoms. Excluded are nursing home residents, recent REMAP participants, patients expected to die within 24 hours without full active treatment commitment, imminent discharges, and those hospitalized over 14 days for a pandemic illness.
What is being tested?
REMAP-CAP evaluates various treatments to improve outcomes in patients with severe pneumonia in the ICU. It includes drugs like Hydroxychloroquine and Sarilumab among others, different ventilation strategies and doses of anticoagulants. The COVID-19 specific sub-platform tests additional interventions against the virus.
What are the potential side effects?
Potential side effects may include allergic reactions to medications, increased bleeding risk from anticoagulants, liver issues from antivirals like Lopinavir/Ritonavir, gastrointestinal disturbances from antibiotics and immune modulators' impact on infection resistance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have symptoms like a cough or trouble breathing.
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I was admitted to the ICU for severe pneumonia within 2 days of coming to the hospital.
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I am an adult hospitalized with a suspected or confirmed pandemic infection.
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My recent scans show new areas of lung infection or damage.
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I am currently receiving medication to help my heart pump more effectively.
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I require a machine to help me breathe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition is terminal, and I or my care team are choosing not to pursue aggressive treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Days alive and not receiving organ support in ICU
Secondary study objectives
Destination at time of hospital discharge
Health-related Quality of life assessment
Other study objectives
Acute kidney injury (KDIGO stage >= 2 acute kidney injury)
Angioedema
Change from baseline AST, ALT and bilirubin
+13 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

18Treatment groups
Experimental Treatment
Group I: Vitamin C DomainExperimental Treatment2 Interventions
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.
Group II: Simvastatin DomainExperimental Treatment2 Interventions
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.
Group III: Mechanical Ventilation DomainExperimental Treatment2 Interventions
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
Group IV: Macrolide Duration DomainExperimental Treatment2 Interventions
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
Group V: Influenza Immune ModulationExperimental Treatment3 Interventions
Patients with community-acquired pneumonia admitted to participating intensive care units with microbiological testing confirmed influenza infection will be randomised to one of three interventions.
Group VI: Influenza Antiviral DomainExperimental Treatment6 Interventions
Patients with community-acquired pneumonia admitted to participating hospitals with microbiological testing confirmed influenza infection will be randomised to one of six interventions.
Group VII: Immunoglobulin DomainExperimental Treatment3 Interventions
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.
Group VIII: Endothelial DomainExperimental Treatment2 Interventions
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.
Group IX: Cysteamine DomainExperimental Treatment2 Interventions
Patients admitted to participating hospitals with severe community-acquired pneumonia, including patients with suspected or proven influenza or COVID-19, will be randomised to receive no cysteamine, or cysteamine. Note: this domain is now closed.
Group X: Corticosteroid DomainExperimental Treatment5 Interventions
Patients with community acquired pneumonia (CAP) admitted to participating hospitals will be randomised to a steroid use strategy. Note: this domain is now closed to patients with suspected or proven COVID-19. It remains open to patients with CAP without COVID-19. Note: the fixed-course hydrocortisone has been closed to recruitment
Group XI: COVID-19 Immune Modulation DomainExperimental Treatment5 Interventions
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.
Group XII: COVID-19 Immune Modulation (2) DomainExperimental Treatment3 Interventions
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.
Group XIII: COVID-19 Antiviral DomainExperimental Treatment5 Interventions
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.
Group XIV: COVID-19 Antiviral (II) DomainExperimental Treatment4 Interventions
Patients admitted to participating hospitals with microbiological testing confirmed COVID-19 will be randomised to one of up to four interventions.
Group XV: Antiplatelet DomainExperimental Treatment3 Interventions
Patients admitted to participating hospitals with suspected or microbiological testing confirmed COVID-19 will be randomised to receive no antiplatelet, aspirin, or site-preferred P2Y12 inhibitor. Note: this domain is now closed.
Group XVI: Anticoagulation DomainExperimental Treatment5 Interventions
Patients admitted to participating intensive care units with suspected or microbiological testing confirmed COVID-19 will be randomised to an anticoagulation strategy. Note: A previous version of this domain evaluated local standard venous thromboprophylaxis against therapeutic dose anticoagulation. This domain is now closed.
Group XVII: Antibiotic DomainExperimental Treatment5 Interventions
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.
Group XVIII: ACE2 RAS DomainExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin
2014
Completed Phase 4
~55580
Eritoran
2015
Completed Phase 2
~10
Remdesivir
2020
Completed Phase 3
~21440
Simvastatin
2012
Completed Phase 4
~1270
Sarilumab
2020
Completed Phase 3
~5980
Baricitinib
2017
Completed Phase 3
~9020
Imatinib
2011
Completed Phase 3
~3940
Tocilizumab
2012
Completed Phase 4
~1840
Apremilast
2017
Completed Phase 4
~2300
Cysteamine
FDA approved
Valsartan
FDA approved
Nirmatrelvir/ritonavir
2023
Completed Phase 2
~260
Anakinra
2016
Completed Phase 4
~1320
Amoxicillin-clavulanate
2016
Completed Phase 4
~2490
Ritonavir
FDA approved
Ivermectin
FDA approved
Convalescent plasma
2020
Completed Phase 3
~1290
Vitamin C
2017
Completed Phase 4
~18470
Interferon beta-1a
FDA approved
Intermediate dose thromboprophylaxis
2020
Completed Phase 4
~180
Clopidogrel
FDA approved
Piperacillin-tazobactam
2016
Completed Phase 4
~530
Enalapril
FDA approved
Ceftaroline
2011
Completed Phase 4
~1900
Hydroxychloroquine
2017
Completed Phase 4
~4070
Ceftriaxone
2019
Completed Phase 4
~9340
Baloxavir Marboxil
2019
Completed Phase 4
~8900

Find a Location

Who is running the clinical trial?

National University Hospital, SingaporeOTHER
506 Previous Clinical Trials
7,371,717 Total Patients Enrolled
St. Marianna University School of MedicineOTHER
8 Previous Clinical Trials
2,423 Total Patients Enrolled
National Intensive Care Surveillance MORUUNKNOWN
Unity HealthOTHER
4 Previous Clinical Trials
2,918 Total Patients Enrolled
Berry ConsultantsOTHER
14 Previous Clinical Trials
37,931 Total Patients Enrolled
Intensive Care National Audit & Research CentreOTHER
14 Previous Clinical Trials
1,635,274 Total Patients Enrolled
Global Coalition for Adaptive ResearchOTHER
1 Previous Clinical Trials
1,030 Total Patients Enrolled
University of Pittsburgh Medical CenterOTHER
75 Previous Clinical Trials
56,943 Total Patients Enrolled
Nat Intensive Care Surveillance - MORUOTHER
2 Previous Clinical Trials
4,625 Total Patients Enrolled
MJM BontenLead Sponsor
6 Previous Clinical Trials
17,904 Total Patients Enrolled

Media Library

Vitamin C Domain Clinical Trial Eligibility Overview. Trial Name: NCT02735707 — Phase 3
Respiratory infection Research Study Groups: Vitamin C Domain, COVID-19 Immune Modulation Domain, COVID-19 Antiviral (II) Domain, Cysteamine Domain, Influenza Immune Modulation, COVID-19 Immune Modulation (2) Domain, Anticoagulation Domain, Immunoglobulin Domain, ACE2 RAS Domain, Endothelial Domain, COVID-19 Antiviral Domain, Antibiotic Domain, Macrolide Duration Domain, Corticosteroid Domain, Influenza Antiviral Domain, Simvastatin Domain, Antiplatelet Domain, Mechanical Ventilation Domain
Respiratory infection Clinical Trial 2023: Vitamin C Domain Highlights & Side Effects. Trial Name: NCT02735707 — Phase 3
Vitamin C Domain 2023 Treatment Timeline for Medical Study. Trial Name: NCT02735707 — Phase 3
Respiratory infection Patient Testimony for trial: Trial Name: NCT02735707 — Phase 3
~2222 spots leftby Feb 2026
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