Randomised Evaluation of COVID-19 Therapy (RECOVERY)
Sponsor: University of Oxford
CI: Prof Peter Horby
Approval Date: 11 March 2020
There are a number of possible treatments for COVID-19 infection available. The Randomised Evaluation of COVID Therapy (RECOVERY) trial will test whether these treatments work better than the treatments that are given in hospital at the moment As well as normal hospital treatment patients with COVID-19 infection will either receive no additional experimental treatment, or will receive one of the following treatments: - a combination of Lopinavir-Ritonavir (antiviral drugs) - interferon β1b (used to treat some kinds of multiple sclerosis) - low-dose corticosteroids (used to reduce inflammation) - hydroxychloroquine (similar to a drug used to treat malaria). The trial is designed so that it can also test other possible treatments as they become available. Information on time in hospital, the number of deaths in hospital, and the need for artificial ventilation will be collected. The study hopes to identify effective treatments within three months. Information is available at https://www.recoverytrial.net/
Background: In early 2020, as this protocol was being developed, there were no approved treatments for COVID-19, a disease induced by the novel coronavirus SARS-CoV-2 that emerged in China in late 2019. A range of potential treatments have been suggested for COVID-19 but nobody knows if any of them will turn out to be more effective in helping people recover than the usual standard of hospital care which all patients will receive. The RECOVERY Trial will begin by testing some of these suggested treatments: MAIN RANDOMISATION A: No additional treatment (standard of care) Lopinavir-Ritonavir (commonly used to treat HIV) - NOW CLOSED DUE TO PRELIMINARY RESULTS SHOWING NO ADDITIONAL EFFICACY Low-dose Dexamethasone (a type of steroid, which is used in a range of conditions typically to reduce inflammation). OPEN TO CHILDREN ONLY AS OF 08/06/2020 Hydroxychloroquine (related to an anti-malarial drug) - NOW CLOSED DUE TO PRELIMINARY RESULTS SHOWING NO ADDITIONAL EFFICACY Azithromycin (a commonly used antibiotic) MAIN RANDOMISATION B: No additional treatment (standard of care) ABO-compatible convalescent plasma (provided by NHS BT) Synthetic neutralising antibodies: developed to bind to and neutralise the virus. SECOND RANDOMISATION Tocilizumab (an anti-inflammatory treatment given by injection) For paediatric patients presenting with the PIMS-TS phenotype, randomisation will be between: Standard of care Normal human immunoglobulin (IVIg) - single dose has been shown to be effective in immunomodulation and preventing cardiovascular complications in Kawasaki disease, an inflammatory condition with overlapping clinical features with PIMS-TS. Methylprednisolone sodium succinate (a type of steroid) Specific medication modifications for pregnant women and paediatric patients can be found in the protocol (https://www.recoverytrial.net/for-site-staff/site-set-up-1/regulatory-documents) Data from the trial will be regularly reviewed so that any effective treatment can be identified quickly and made available to all patients. The RECOVERY Trial team will constantly review information on new drugs and include promising ones in the trial. Outcomes: The main outcomes will be in-hospital death, discharge, and need for ventilation. For the main analyses, follow-up will be censored at 28 days after admission. Additional information on longer term outcomes may be collected through review of medical records or linkage to medical databases such as those managed by NHS Digital and equivalent organisations in the devolved nations.
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