OBJECTIVES

: Inspired by the SOLIDARITY trial for pharmacological treatment of COVID-19 launched by WHO on March 18^th, 2020, France and the UK started the DisCoVeRy trial and the RECOVERY trial, respectively. This study aims to compare the implementability between the RECOVERY trial and the DisCoVeRy trial.

METHODS

The study design and implementability of adaptive trials were compared between the RECOVERY trial and the DisCoVeRy trial, including study objective, population, enrolment date, completion date, number of amendments, sample size, interventions, outcomes, and preliminary results.

RESULTS

With adaptive design, both trials aim to test the efficacy and safety of potential therapies in hospitalized COVID-19 patients. Initially launched on March 19^th and March 22^nd, 2020, the RECOVERY trial with five amendments and the DisCoVeRy trial with one amendment were estimated to complete on December 2020 and March 2023, respectively. Targeting 12,000 patients, the interventions in the RECOVERY trial included lopinavir-ritonavir, hydroxychloroquine, low-dose corticosteroids, and azithromycin, with tocilizumab and convalescent plasma added in the 4^th and 6^th amendment. Targeting 2,100 patients, the interventions in the DisCoVeRy trial included remdesivir, lopinavir-ritonavir, lopinavir-ritonavir-interferon beta, and hydroxychloroquine. The RECOVERY trial collected the primary outcome of mortality rate, three secondary outcomes and two other outcomes at day 28 and month 6. The DisCoVeRy trial collected the primary outcome of severity rating on a 7-point ordinal scale, 23 secondary outcomes and five other outcomes at different timepoints repeatedly, eventually leaving more than 100 outcomes to be collected. The preliminary results of the RECOVERY trial were published on June 5^th, 2020, while discovery has failed to recruit patients.

CONCLUSIONS

: Unlike the DisCoVeRy trial that was a perfect academic trial but infeasible, the RECOVERY trial prioritized feasibility and flexibility appropriately in the context of COVID-19 emergency to inform the control of mortality and rational use of scarce resources.