Remdesivir has lowered the risk of death in critically ill COVID-19 patients by 62 percent, preliminary data released by the drugmaker Gilead suggests.
The additional research on Remdesivir presented at last week's Virtual COVID-19 Conference provides updated SIMPLE-Serious Phase 3 comparative study and a real-world retrospective cohort of COVID-19 severe patients.
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Here's what happened
During this study, remdesivir demonstrated an increase during clinical recovery and a remarkable 62 percent decrease in death risk and helped speed up patient's recovery.
The latest results came from two studies: a Phase III trial of 312 patients, evaluating the drug 's efficacy, and a report that analyzed the drug's effect in 818 people with COVID-19 retrospectively. The organization also found that 74.4% of people taking remdesivir were recovered by day 14, compared to 59% of those seeking standard treatment.
Analysis from various subgroups studied in the study also evaluated the safety and efficacy of remdesivir across specific racial and ethnic subgroups of patients. Comes from these analyzes showed that "traditionally disadvantaged racial or ethnic groups" treated with remdesivir reported comparable outcomes to the general population of patients.
Gilead also announced new analyzes from its compassionate use plan. The results showing that 83% of pediatric patients and 92% of pregnant and postpartum women with a broad range of disease severity improved by day 28 of therapy.
What's the catch?
Some analysts have addressed the validity of the data, given that the source of the analysis is not from a randomized, placebo-controlled clinical trial, but instead compares clinical trial data to non-clinical trial data.
However, drug developers are releasing any data which may show a benefit against the disease as the need for treatments grows increasingly critical. Gilead acknowledged this fact; its chief medical officer Merdad Parsey commented on the release of this data last week.
"To address the urgency of the continuing pandemic, we are sharing data with the research community as quickly as possible with the goal of providing transparent and timely updates on new developments with remdesivir," Parsey said in a statement.
He noted that the Virtual COVID-19 Conference shed additional light on the use of remdesivir in specific patient populations. The patients include those who are susceptible to higher rates of COVID-19 infection, children, and pregnant and postpartum women.
Former US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said robust evidence is required to validate the results further. In his official Twitter account, he said new results are auspicious but must be verified in a prospective trial.
"It appears to be a retrospective analysis of the phase 3 data using historical matched controls, suggesting a survival benefit in severe COVID-19 patients," he added.
Remdesivir is currently intravenously administered to individuals diagnosed with COVID-19. But other researchers believe it would be even safer to give the medication earlier in an infection. Gilead revealed on July 8 that a clinical trial will begin to test the efficacy of an inhaled version of the drug. If the inhaled form is safe and effective it may be used to treat individuals at home. The company also announced that testing of the intravenous drug in children would begin.
