Eligibility
Local study conflicts
- Patients who are enrolled into TILIA cannot be enrolled into RECOVERY
Inclusion Criteria:
- Patient is being admitted to the hospital
- and
- Patient has been diagnosed with a pneumonia syndrome:
- In general, pneumonia should be suspected when a patient presents with:
- typical symptoms of a new respiratory tract infection (e.g. influenza-like illness with fever and muscle pain, or respiratory illness with cough and shortness of breath);
- objective evidence of acute lung disease (e.g. consolidation or ground-glass shadowing on X-ray or CT, hypoxia, or compatible clinical examination);
- alternative causes have been considered unlikely or excluded (e.g. heart failure).
- However, the diagnosis remains a clinical one based on the opinion of the managing doctor (the above criteria are just a guide).
- and
- One of the following diagnoses:
- Confirmed SARS-CoV-2 infection (including patients with influenza co-infection)
- Confirmed influenza A or B infection (including patients with SARS-CoV-2 co-infection)
- Community-acquired pneumonia with planned antibiotic treatment (excluding patients with suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia)
- and
- No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial
- n.b.
- Patients with SARS-CoV-2 and influenza co-infection are eligible, but would be excluded from certain comparisons (as described in the table on page 1). In addition, if the attending clinician believes that there is a specific contra-indication to one of the active drug treatment arms (see Appendix 2, Appendix 3 for children, and Appendix 4 for pregnant and breastfeeding women) or that the patient should definitely be receiving one of the active drug treatment arms then that arm will not be available for randomisation for that patient. For patients who lack capacity, an advanced directive or behaviour that clearly indicates that they would not wish to participate in the trial would be considered sufficient reason to exclude them from the trial.
- Patients who have been previously recruited into RECOVERY are eligible to be recruited again as long as their previous randomisation was >6 months ago. Patients will not be recruited into the same randomised comparison (e.g. sotrovimab vs. usual care) on more than one occasion, regardless of how far apart they occur.
Exclusion Criteria:
- patients who lack capacity, an advanced directive or behaviour that clearly indicates that they would not wish to participate in the trial
Gain verbal agreement in principle before proceeding. Explain:
- Taking part in research is likely to improve the quality of their care
- Risks are carefully controlled - research is safe
- Explain the uncertainty that exists with respect to treatment of their condition;
- If they change their mind they can withdraw their participation at any point
Step by Step Guide to Recruitment:
In the working hours of the research team:
- Monday-Friday 07:30 – 18:30
- Contact the EMROx research team on:
Mobile 0776818242
Tel 01865 222003
Bleep 6680
Out of hours and weekends:
- Patients can only be recruited during the research team's working hours.