Results from expanded access programs: a review of academic literature 153 7♦ Comparison with other data When comparing the expanded access program with clinical trials, the authors conclude that: • ‘Although data from randomized, controlled trials will soon provide more informative evidence regarding the safety and efficacy of remdesivir for Covid-19, the outcomes observed in this CUP are the best currently available data.’ • ‘By way of comparison with a controlled trial, case series, and cohort studies, the 13% mortality observed in this remdesivir compassionate-use cohort is noteworthy, considering the severity of disease in this patient population; however, the patients enrolled in this compassionate-treatment program are not directly comparable to those studied in these other reports. Difference occurs for example in receiving invasive ventilation, coexisting conditions, and age.’ Several limitations to the study are mentioned: ‘Interpretation of the results of this study is limited by the small size of the cohort, the relatively short duration of follow-up, potential missing data owing to the nature of the program, the lack of information on eight of the patients initially treated, and the lack of a randomized control group.’ Conclusion The authors conclude that: ‘(These data) suggest that remdesivir may have clinical benefit in patients with severe Covid-19.’ The authors advise the conduct of prospective randomized controlled trials: ‘Measurement of efficacy will require ongoing randomized, placebo-controlled trials of remdesivir therapy.’
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