1 July 2020
DisCoVeRy trial in practice
The DisCoVeRy clinical trial is an adaptive, randomized, open-label clinical trial, add-on of the Solidarity trial, that aims to evaluate the safety and efficacy of four antiviral therapeutic strategies as compared with standard of care. Patients are hospitalized in conventional departments or intensive care units both from academic or non-academic hospitals throughout Europe with COVID-19 and need of oxygen therapy.
But what actually is an adaptative, randomised, open-label clinical trial ?
Adaptative means therapeutic strategies evaluated in this trial can be modified according to new evidence: one of them can become the standard of care if proved superior to others, one can be dis-continued if proved inferior to others and extra treatments can be added if new candidate therapeutic strategies emerge. Randomized means patients can’t choose the treatment they’re going to receive. But they should know after randomization as there are different routes of administration (intravenous, subcutaneous or oral). And it’s open-label as there is no placebo group and researchers and participants know which drug is being administrated.
Volunteers are randomly assigned to five groups: standards of care without trial drug, standards of care plus remdesivir, standards of care plus lopinavir/ritonavir, standards of care plus lopinavir/ritonavir associated with interferon and standards of care plus hydroxychloroquine.
The primary endpoint is the clinical status at Day 15 after randomization.
Florence Ader, Discovery French Trial Management Team
Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults
BMJ Open 2020;10:e041437