Some of the Gilead Remdesivir Results from Recent Studies

Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19A Randomized Clinical Trial, JAMA, Christoph D. Spinner, MDRobert L. Gottlieb, MD, PhDGerard J. Criner, MD, August 21, 2020

This is a freebie so you should be able to get into this article and pickup on additional detail. Those who were treated early on had a better result from remdesivir than those who were treated later after contracting Covid. This was already know,.

Results:  Among 596 patients who were randomized, 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial. Median length of treatment was 5 days for patients in the 5-day remdesivir group and 6 days for patients in the 10-day remdesivir group.

On day 11, patients in the 5-day remdesivir group had statistically significantly higher odds of a better clinical status distribution than those receiving standard care (odds ratio, 1.65; 95% CI, 1.09-2.48; P = .02).

The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test). By day 28, 9 patients had died: 2 (1%) in the 5-day remdesivir group, 3 (2%) in the 10-day remdesivir group, and 4 (2%) in the standard care group. Nausea (10% vs 3%), hypokalemia (6% vs 2%), and headache (5% vs 3%) were more frequent among remdesivir-treated patients compared with standard care.

Some Limitations: This study has several limitations. First, the original protocol was written when COVID-19 cases were largely confined to Asia and the clinical understanding of disease was limited to case series. This led to a change in the primary end point on the first day of study enrollment as it became clear that hospital discharge rates varied greatly across regions and the ordinal scale had become standard for interventional COVID-19 studies. Second, the study used an open-label design, which potentially led to biases in patient care and reporting of data. Third, because of the urgent circumstances in which the study was conducted, virologic outcomes such as effect of remdesivir on SARS-CoV-2 viral load were not assessed. Fourth, other laboratory parameters that may have aided in identifying additional predictors of outcomes were not routinely collected. Fifth, the ordinal scale used to evaluate outcomes was not ideal for detecting differences in patients with moderate COVID-19, especially for a clinical situation in which discharge decisions may be driven by factors other than clinical improvement.

Conclusions: Among patients with moderate COVID-19, those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance.

This is BS.

Comments (7) | |