REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia. (COVID-19)

Phase 1

• Conditions: Patients with Community-Acquired Pneumonia and suspected or confirmed COVID-19 infection.; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-002340-14-IT
• Lead Sponsor: IVERSITY MEDICAL CENTER UTRECHT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-12
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 7100

Inclusion Criteria

In order to be eligible to participate in this trial, a patient must meet the following criteria: Adult patients (= 18 years) with suspected or proven COVID-19 infection and concomitant severe CAP. 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. Within REMAP, eligible participants will be randomized to receive an intervention in each of one or more domains. Italian centers will participate exclusively in the COVID-19 domains. A domain is a treatment category that contains one or more options, called interventions.
Each domain then has specific inclusion criteria, which are detailed in the attached protocols.
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 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 480

Exclusion Criteria

A potentially eligible patient who meets any of the following criteria will be excluded from participation in this trial:
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
3.Patient refuse to sign the informed consent.
Each domain may have additional eligibility criteria. Refer to the study protocols.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified