Randomized evaluation of COVID-19 therapy
Severe Acute Respiratory Syndrome, COVID-19 (SARS coronavirus 2 [SARS-CoV-2] infection), Influenza A, Influenza B, Viral pneumonia syndrome, Community-acquired pneumonia, Bacterial pneumonia syndrome
Current interventions as of 29/06/2026: RECOVERY is a randomised trial among people hospitalised for pneumonia. Eligible patients are randomly allocated between several treatment arms, each to be given in addition to the usual standard of care in the participating hospital. For patients for whom not all the trial arms are appropriate or at locations where not all are available, randomisation will be between fewer arms. RECOVERY has an adaptive trial design. The interim trial results are monitored by an independent Data Monitoring Committee (DMC). The DMC will assess whether the randomised comparisons in the study have provided evidence that is strong enough (with a range of uncertainty around the results that is narrow enough) to affect national and global treatment strategies. In such a circumstance, the DMC will inform the Trial Steering Committee who will make the results available to the public and amend the trial arms accordingly. New trial arms can be added as evidence emerges that other candidate therapeutics should be evaluated. Drug dosage and duration - COVID-19 arms (all now closed with results reported): COVID-19 Main randomisation part A (recruitment to Part A is now finished with results reported) One of the following treatments were allocated simultaneously with randomisation part D, E or F (if appropriate, not all treatments were available in all countries). 1. Lopinavir 400 mg + ritonavir 100 mg: by mouth (or nasogastric tube) every 12 h for 10 days or until discharge 2. Corticosteroid in the form of dexamethasone: administered as an oral (liquid or tablets) or intravenous preparation 6 mg once daily for 10 days. In pregnancy or breastfeeding women, prednisolone 40 mg administered by mouth (or intravenous hydrocortisone 80 mg twice daily) should be used instead of dexamethasone Corticosteroid (in children ≤44 weeks gestational age, or >44 weeks gestational age with PIMS-TS only) in the form of hydrocortisone or methylprednisolone sodium succina
Current inclusion criteria as of 29/06/2026: Note: the eligibility criteria have changed from COVID-19 to pneumonia (Influenza & CAP). For detailed information about previous eligibility criteria, please see the previous Protocols on the study website: https://www.recoverytrial.net/uk/for-site-staff/site-set-up-1/regulatory-documents 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 (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 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. _____ Previous inclusion criteria as of 04/12/2023: 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: a) 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 b) objective evidence of acute lung disease (e.g. consolidation or ground-glass shadowing on X-ray or CT, hypoxia, or compatible clinical examination); and c) alternative causes have been considered unlikely or excluded (e.g. heart failure). However, the diagnosis remain
Current exclusion criteria as of 29/06/2026: 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. In some locations, children (aged <18 years) will not be recruited to comply with local and national regulatory approvals (see Appendix 6). _____ Previous exclusion criteria as of 04/12/2023: Participants will be excluded if the attending clinician believes that there is a specific contra-indication to one of the active drug treatment arms (see Protocol Appendix 2; section 8.2, Appendix 3; section 8.3 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