RECOVERY

Phase 1

Recruiting

• Conditions: Pneumonia; MedDRA version: 20.0Level: PTClassification code: 10035664Term: Pneumonia Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; Therapeutic area: Diseases [C] - Virus Diseases [C02]; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-507441-29-00
• Lead Sponsor: niversity Of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-09
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

Hospitalised patients aged =18 years, Pneumonia syndrome (clinical diagnosis, in general based on a) typical symptoms of new respiratory infection, b) objective evidence of acute lung disease [e.g. hypoxia or compatible imaging or clinical examination], and c) alternative causes considered unlikely, One of the following diagnoses: a) Confirmed influenza A or B infection b) Community-acquired pneumonia with planned antibiotic treatment (without suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis, or Pneumocystis pneumonia), No medical history that might, in the opinion of the patient’s doctor, put the patient at significant risk if he/she were to participate in the trial, No reason that the trial treatment definitely should, or should not, be given in the opinion of the patient’s doctor (this only affects eligibility for the relevant comparison)

Exclusion Criteria

No exclusion criteria

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To provide reliable estimates of the effect of study treatments on mortality and time to discharge from hospital;Secondary Objective: To assess the effect of study treatment on progression to invasive mechanical ventilation or extracorporeal membrane oxygenation;Primary end point(s): 28 day all-cause mortality, Time to discharge alive from hospital within 28 days (patients with influenza only)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Time to discharge alive from hospital within 28 days (patients without influenza);Secondary end point(s):Progression to invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death within 28 days