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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

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

Remdesivir

2020

Completed Phase 3

~21440

Valsartan

FDA approved

Cysteamine

FDA approved