Status:
RECRUITING
Randomised Evaluation of COVID-19 Therapy
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
UK Research and Innovation
National Institute for Health Research, United Kingdom
Conditions:
Severe Acute Respiratory Syndrome
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
RECOVERY is a randomised trial of treatments to prevent death in patients hospitalised with pneumonia. The treatments being investigated are: COVID-19: Lopinavir-Ritonavir, Hydroxychloroquine, Corti...
Detailed Description
The RECOVERY trial has already shown that: * Dexamethasone (a type of steroid) reduces the risk of dying for patients hospitalised with COVID-19 receiving oxygen, * Regeneron's monoclonal antibody co...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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:
- 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
- objective evidence of acute lung disease (e.g. consolidation or ground-glass shadowing on X-ray or CT, hypoxia, or compatible clinical examination); and
- 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:
- 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)
- Exclusion criteria:
- (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
- 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, and 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 be considered sufficient reason to exclude them from the trial.
Exclusion
Key Trial Info
Start Date :
March 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2036
Estimated Enrollment :
70000 Patients enrolled
Trial Details
Trial ID
NCT04381936
Start Date
March 19 2020
End Date
June 30 2036
Last Update
January 5 2024
Active Locations (7)
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1
Kumasi Center for Collaborative Research in Tropical Medicine KNUST
Kumasi, Ghana
2
Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases
New Delhi, India, ICMR-110029
3
Eijkman Oxford Clinical Research Unit (EOCRU), Eijkman Institute for Molecular Biology
Jakarta, Indonesia
4
Clinical Trial Unit, Oxford University Clinical Research Unit-Nepal, Patan Academy of Health Sciences
Kathmandu, Nepal