Adaptive trial in severe pneumonia (REMAP-CAP)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 4000

Inclusion Criteria

General REMAP-CAP Inclusion Criteria:
1. Adult patient admitted to an ICU for acute severe CAP within 48 hours of hospital admission with
a. symptoms or signs or both that are consistent with lower respiratory tract infection (for example, acute onset of dyspnea, cough, pleuritic chest pain) AND
b. Radiological evidence of new onset infiltrate of infective origin (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:
a. Non-invasive or invasive ventilatory support;
b. Receiving infusion of vasopressor or inotropes or both

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000

Exclusion Criteria

General REMAP-CAP Exclusion Criteria:
1. Healthcare-associated pneumonia:
a. Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days
b. 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

There are domain-specific exclusion criteria in the Antibiotic, macrolide duration, cortisteroid and antiviral domain. These have not changed compared to previous submission. Due to maximum number of characters, these have been cut and only the domain-specific and interaction-specific exclusions for the two new domains are mentioned.

COVID-19 Immune Modulation domain:
Patients will be excluded from this domain if they have any of the following:
• More than 24 hours has elapsed since ICU admission
• Patient has already received any dose of any form of interferon or anakinra, or is on long-term therapy with any of these agents prior to this hospital admission
• Known condition or treatment resulting in ongoing immune suppression including neutropenia prior to this hospitalization
• Patient has been randomized in a trial evaluating an immune modulation agent for proven or suspected COVID-19 infection, where the protocol of that trial requires ongoing administration of study drug
• The treating clinician believes that participation in the domain would not be in the best interests of the patient

Patients may also be excluded from receiving one or more interventions within the domain for patient-specific reasons. In such cases, patients will be randomly allocated a remaining intervention from among those available at that site.
Patients who are eligible for only a single intervention at a site (i.e. all other interventions are contraindicated) are not eligible for this domain. Patients in whom all interventions are contraindicated will be treated according to the current standard of care at the clinician’s discretion.
• Known hypersensitivity to an agent specified as an intervention in this domain will exclude a patient from receiving that agent
• Receiving an agent that is specified as an intervention in this domain as a usual medication prior to this hospitalization will exclude a patient from receiving that agent
• Intention to prescribe systemic corticosteroids for any reason, other than participation in the Corticosteroid Domain of this platform, will result in exclusion from receiving IFN-ß1a
• Known hypersensitivity to proteins produced by E. coli will result in exclusion from receiving anakinra
• Known or suspected pregnancy will result in exclusion from the anakinra and IFN-ß1a interventions. It is normal clinical practice that women admitted who are in an age group in which pregnancy is possible will have a pregnancy test conducted. The results of such tests will be used to determine interpretation of this exclusion criteria.

COVID-19 antiviral therapy domain:
Patients will be excluded from this domain if they have any of the following:
• More than 24 hours has elapsed since ICU admission
• Patient has already received more than 36 hours of treatment with any non-trial prescribed systemic antiviral medication intended to be active against COVID-19 during this hospital admission
• Patient has been randomized in a trial evaluating

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Adaptive trial in severe pneumonia Coronavirus COVID-19 (REMAP-CAP-COVID-19)

Phase 1

niversity Medical Center Utrecht

Updated 4/6/2020