Gilead has announced on Monday positive results of the assay in phase III of the drug remdesivir in patients with COVID-19 moderate: the study shows that the treatment cycle of 5 days provides an improvement cynical “significantly higher” compared to the standard treatment.
This is the clinical trial SIMPLE and known data today add to the evidence of previous work announced a month ago that show the “benefit” of remdesivir in patients with COVID-19 grave, points to the pharmaceutical company in a press note.
Research -clinical trials consist of three phases – it has been done this time with hospitalized patients with pneumonia moderated by COVID-19 and have evaluated treatment schemes of 5 and 10 days with remdesivir (antiviral research) plus the standard treatment, in comparison only with the latter.
The study shows that patients in the treatment group for 5 days with remdesivir have a 65% more likely to have a clinical improvement at day 11 in comparison with the group that received only the standard treatment.
The odds of improvement with the treatment cycle of 10 days of remdesivir in comparison to the standard treatment have also been favorable, showing a positive trend, but “not statistically significant” according to the note of Gilead.
The u.s. pharmaceutical ensures that we have not identified any new signals related to the safety of remdesivir in any treatment group.
Gilead is working on the revision and submission in the coming weeks for full details of the study for publication in a scientific journal.
“Our understanding of gravity, in all its spectrum, of the infection by SARS-CoV-2, and presentations of COVID-19 continue to evolve,” says Francisco Marty, a specialist in infectious diseases at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School.
For this doctor, “the results of this study offer additional data encouraging for remdesivir, we show that, if we can intervene earlier in the progression of the disease with a treatment cycle of 5 days, could significantly improve the clinical outcomes for these patients.”
Remdesivir was generally well tolerated in the treatment groups of 5 and 10 days; symptoms most common adverse events that occurred in more than 5% of patients in both treatment groups were nausea, diarrhea, and headache.
Gilead reports that remdesivir is currently approved in Japan as treatment for patients infected by SARS-CoV-2, the virus that causes COVID-19; outside of this country, is an investigational product not approved.
The Agency of Medicines and Foods of united States (FDA) granted remdesivir an authorization of emergency use for the treatment of hospitalized patients with COVID-19 severe; the authorization is temporary and does not replace the formal process of submission, review and approval of applications for new medicines, according to the same sources.