The interventional study conducted by Spinner et al. aimed to evaluate the
efficacy of remdesivir for patients hospitalized with moderate coronavirus
disease, specifically in comparison to standard care. The primary endpoint –
assessing the proportion of hospitalized patients discharged by day 14 of the
study – was determined in advance. However, as patients were enrolled
between March 15, 2020 and April 14, 2020 (the onset of the global
pandemic), emerging evidence and data shed new light onto clinical
presentation of COVID-19. Thus, a modification was made to the endpoint –
rather than measuring the proportion of hospitalized patients, clinical status
was assessed on a 7-point ordinal scale by day 11. This change does not
seem problematic to study validity since the protocol was amended March
15
th
, the first day of patient enrollment (rather than being a retrospective
decision once the study had been completed).
The study involved multi-centers, as patients were enrolled across hospitals
from three continents (North America, Europe, and Asia). Some advantages
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