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

Randomised Evaluation of COVID-19 Therapy

Phase 3 Interventional University of Oxford · NCT04381936

This study tests different treatments to see if they can help hospitalized COVID-19 patients with pneumonia live longer and feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment70000 (estimated)
Ages0 Years and up
SexAll
SponsorUniversity of Oxford Academic / other
Drugs / interventionssotrovimab, Casirivimab, Imdevimab, Tocilizumab, Baricitinib
Locations16 sites (Brussels and 15 other locations)
Trial IDNCT04381936 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are hospitalized patients diagnosed with pneumonia and confirmed SARS-CoV-2 or influenza infections.

Not a fit: Patients with mild COVID-19 symptoms who are not hospitalized are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this trial could significantly reduce mortality rates among hospitalized patients suffering from severe COVID-19 pneumonia.

How similar studies have performed: Previous studies, including the RECOVERY trial, have shown success with similar approaches in treating COVID-19 patients.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Brussels and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions PneumoniaCOVID-19SARS-CoV-2SARS coronavirus 2SARSViral pneumonia syndromeCommunity-acquired pneumoniaBacterial pneumonia syndrome
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.