Background

The RECOVERY Protocol describes an overarching trial design to provide reliable evidence on the efficacy of candidate therapies for confirmed COVID-19 in hospitalised patients receiving the usual standard of care. The focus of RECOVERY is the impact of candidate treatments on mortality and on the need for hospitalisation/ventilation. This trial randomises eligible participants to the usual standard of care for the local hospital alone vs the usual standard of care plus one/more additional study treatments. Randomisation will always be relevant to the current clinical situation, and the incremental effects of the study treatments will be appropriately assessed.

Study Design

Well-designed, pragmatic, and easy to implement clinical trials are key to generating the evidence needed to best manage pandemic diseases, which occur essentially in emergency situations. The RECOVERY trial sets this paradigm. It is a large open-label factorial designed platform trial that enables the simultaneous testing of multiple different treatments. As particular treatments are found to be effective or ineffective, they are dropped from the trial and should form part of the standard of care.

The study is designed to have high power to deliver precise estimates of the effect of particular treatments on the risk of death. New treatment interventions are added to the trial as evidence emerges from small scale studies of their possible value. While originally based in the UK, the extension of the RECOVERY trial to international sites, building upon well-established clinical research networks and collaborations, will ensure that the results of the trial have global relevance.

Outputs to date

Having enrolled more than 47,000 patients to date,  RECOVERY has provided precise data demonstrating the efficacy of dexamethasone, tocilizumab, and a cocktail of CoV antibodies (Regeneron) in reducing the risk of death in hospitalized patients, and that hydroxychloroquine, azithromycin, lopinavir-ritonavir, aspirin, colchicine, and convalescent plasma are ineffective. These results have influenced World Health Organisation and national guidelines for the treatment of COVID19. Current treatments undergoing evaluation include high dose corticosteroids and empagliflozin.