#15 day plan coronavirus trial#

With those kind of results, one would be led to believe that after five days of treatment, stop because additional treatment makes things worse, and that could be a legitimate result, since there may be other effects besides just arresting viral replication. While there is some difference between standard care at the 5 day level, 10 day level seems to go the other way, which intuitively doesn't make much sense. For the trivial price of a few hundred empty vials with Veklury labels, Gilead Sciences sacrificed the more accurate results that could have been obtained from a placebo-controlled trial, and the resulting clinical benefits to their customers' patients, and potential profits to their company's shareholders. The authors state: 'Treatment was open label because the sponsor had an insufficient number of placebo-containing vials to support this trial.'Д«ut surely the cost of providing vials of saline placebo would have to be utterly miniscule to the sponsor of this trial, Gilead Sciences, a large, well-capitalized pharmaceutical company which owns the patent on remdesivir (brand-named 'Veklury'). Given the greater accuracy of double-blinded placebo-controlled trials compared with open-label trials for measuring treatment effects, it is important to discuss why the investigators chose not to invest whatever additional resources would have been required to have provided a double-blinded placebo control. Contrariwise, the nocebo effect could have falsely detracted from the magnitude of treatment benefit. Therefore, the placebo effect cannot be ruled out as falsely contributing some or all of the putative benefits of treatment.

#15 day plan coronavirus trial#

Therefore, the results of this trial are not placebo-controlled, nor controlled for other expectation effects.ДЇurthermore, the impact of expectation effects is magnified in this trial by the small or absent differences in clinical outcomes between the three groups of subjects, and the reliance on statistical analysis to detect these differences. In an open-label clinical trial such as this, every participant and physician was potentially aware of whether placebo or remdesivir (the medication under investigation), was being administered in each case. I'd rather say that, at this time, we do not have any convincing evidence that RMD could improve recovery of patients hospitalized with COVID-19. Therefore, I beg to disagree with the statement made in the joining editorial comment 'Some of the RCT findings suggest remdesivir could improve recovery for many millions of individuals around the world who may be hospitalized with COVID-19.' This observation alone should lead us to seriously question the meaningfulness of the statistical significance observed in the 5-day RMD treatment group. The authors duly mention several limitations of this open-label study.В One point though that does not seem to be sufficiently discussed is the discrepancy observed between the statistically significant difference of the 5-day remdesivir (RMD) course vs standard care (SC) and the lack of significance of the 10-day RMD course vs SC taking into consideration that the actual median treatment length was 5 vs 6 days! So, with one additional day of treatment length, statistical significance is lost. Shared Decision Making and Communication.

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