Publications by authors named "Assia Ferrane"
Background: We aimed to evaluate the cardiac adverse events (AEs) in hospitalized patients with coronavirus disease 2019 (COVID-19) who received remdesivir plus standard of care (SoC) compared with SoC alone (control), as an association was noted in some cohort studies and disproportionality analyses of safety databases.
Methods: This post hoc safety analysis is based on data from the multicenter, randomized, open-label, controlled DisCoVeRy trial in hospitalized patients with COVID-19. Any first AE that occurred between randomization and day 29 in the modified intention-to-treat (mITT) population randomized to either remdesivir or control group was considered.
Setting: Health measures taken during the pandemic deeply modified the clinical research practices. At the same time, the demand for the results of the COVID-19 trials was urgent. Thus, the objective of this article is to share Inserm's experience in ensuring quality control in clinical trials in this challenging context.
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- The COVID-19 pandemic caused problems for drug testing since there were no effective treatments known at the start, leading researchers to try different drugs.
- The Inserm Safety Department had to handle a lot of serious health problems reported during a big drug trial, with over 580 cases that required attention and follow-ups.
- The pandemic made it really hard for researchers to get clear information about patient problems, which slowed down the process of ensuring safety for people in the trial.