Study shows that patients in the 5-day remdesivir treatment group are 65% more likely to have a clinical improvement on day 11 compared to those in the group who received only the standard of treatment.
Gilead announced Monday positive results from the phase III trial of the drug remdesivir in patients with moderate covid-19: the study shows that the 5-day treatment cycle offers a “significantly greater” cynical improvement against the treatment standard.
This is the SIMPLE clinical trial and the data known today adds to the evidence of previous works announced a month ago that demonstrate “the benefit” of remdesivir in patients with severe covid-19 , the pharmaceutical company notes in a press release.
The research – the clinical trials consist of three phases – has been carried out this time with hospitalized patients with moderate covid-19 pneumonia and 5 and 10 day treatment schedules with remdesivir (research antiviral) plus the standard have been evaluated. of treatment, compared only with the latter.
The study shows that patients in the 5-day remdesivir treatment group are 65% more likely to have a clinical improvement on day 11 compared to those in the group receiving the standard of treatment alone.
The odds of improvement with the 10-day treatment cycle of remdesivir compared to the treatment standard have also been favorable, showing a positive trend, but “without reaching statistical significance,” according to the Gilead note.
The American pharmacist assures that no new safety-related signs of remdesivir have been identified in any treatment group.
Gilead is working on reviewing and submitting the full study data in the coming weeks for publication in a scientific journal.
Our understanding of the severity, across its spectrum, of SARS-CoV-2 infection and covid-19 presentations continue to evolve, says Francisco Marty, infectious disease specialist 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 encouraging data for remdesivir, showing that, if we can intervene earlier in the progression of the disease with a 5-day treatment cycle, the clinical results for these patients could be significantly improved “ .
Remdesivir was generally well tolerated in the 5 and 10 day treatment groups; The most common adverse symptoms 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 a treatment for patients infected with SARS-CoV-2, the virus that causes covid-19; Outside of this country, it is an investigational drug not approved.
The United States Food and Drug Administration (FDA) granted an emergency use authorization for the treatment of hospitalized patients with severe covid-19; the authorization is temporary and does not replace the formal process for submitting, reviewing and approving applications for new drugs, according to the same sources.