Evaluation of treatments to prevent death in hospitalized COVID-19 patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates various treatments aimed at reducing mortality in patients hospitalized with pneumonia due to COVID-19. It includes a range of interventions such as corticosteroids, monoclonal antibodies, and antiviral medications. The study is designed to assess the effectiveness of these treatments in improving patient outcomes, particularly in those with severe respiratory symptoms. The RECOVERY trial has previously identified effective therapies and aims to further evaluate additional options.

Why it matters

Who can join: the full rules

Eligibility Criteria (as per Protocol v28.0):

Patients are eligible for the study if all of the following are true:

(i) Hospitalised

(ii) Pneumonia syndrome

In general, pneumonia should be suspected when a patient presents with:

1. 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); and
2. objective evidence of acute lung disease (e.g. consolidation or ground-glass shadowing on X-ray or CT, hypoxia, or compatible clinical examination); and
3. 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).

(iii) One of the following diagnoses:

1. Confirmed influenza A or B infection (including patients with SARS-CoV-2 co-infection)
2. Community-acquired pneumonia (CAP) with planned antibiotic treatment (excluding patients with suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia)

(iv) 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

Patients with suspected or confirmed active pulmonary tuberculosis or Pneumocystis jirovecii pneumonia (also known as PCP or PJP) are excluded from the CAP comparison, as these infections are caused by specific organisms with distinct pathologies, and so are not usually categorised as CAP. Eligibility for the CAP comparison also requires planned antibiotic treatment, so patients being treated solely for fungal or viral pneumonia are not eligible.

Patients with SARS-CoV-2 and influenza co-infection are eligible, but would be excluded from certain comparisons if the attending clinician believes that there is a specific contra-indication to one of the active drug treatment arms (see Protocol 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.

In some locations, children (aged \<18 years) will not be recruited, to comply with local and national regulatory approvals (see Appendix 6).

Note: the eligibility criteria has changed from COVID-19 to pneumonia (Influenza \& CAP). For detailed information about previous eligibility criteria please see the previous Protocol's on the study website: https://www.recoverytrial.net/uk/for-site-staff/site-set-up-1/regulatory-documents

Where it's running

• Belgian sites are managed by the European Clinical Research Alliance on Infectious Diseases
  Brussels, Belgium Recruiting
• Estonian sites are managed by the European Clinical Research Alliance on Infectious Diseases
  Tallinn, Estonia Recruiting
• French sites are managed by the European Clinical Research Alliance on Infectious Diseases
  Paris, France Recruiting
• Kumasi Center for Collaborative Research in Tropical Medicine KNUST
  Kumasi, Ghana Recruiting
• Eijkman Oxford Clinical Research Unit (EOCRU), Eijkman Institute for Molecular Biology
  Jakarta, Indonesia Recruiting
• Italian sites are managed by the European Clinical Research Alliance on Infectious Diseases
  Roma, Italy Recruiting

Study contacts

• Principal investigator: Peter W Horby — University of Oxford
• Study coordinator: Leon Peto
• Email: recoverytrial@ndph.ox.ac.uk
• Phone: +44 (0)1865 743743

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• FUNGAL-P: A score to spot fungal pneumonia early in adults with pneumonia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.