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

Phase 1

• Conditions: Severe Community Acquired Pneumonia; MedDRA version: 20.1Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-002340-14-FR
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-27
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 4000

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
3. Proven or suspected COVID-19 infection

Precisions for the French part :
1.Patients under guardianship or curatorship
2.Informed written consent of the patient or a legally authorized close relative, or emergency procedure.

In view of the exceptional and urgent situation, affiliation to a social security scheme will not be a criterion for inclusion.

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

Any of:
1.Non COVID-19 pneumonia

Precisions for the French part :
1.Patients under guardianship or curatorship
2.Informed written consent of the patient or a legally authorized close relative, or emergency procedure.

In view of the exceptional and urgent situation, affiliation to a social security scheme will not be a criterion for inclusion.

Study & Design

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