Drug-maker Gilead has reported the most recent results of a research of its speculative medicine remdesivir in treating severe COVID-19 cases, as well as it’s the tentative right information in the search for coronavirus treatment. Not yet licensed or accepted for use in cases of COVID-19, remdesivir has been the subject of a continuous Phase 3 medical trial exploring whether 5- or 10-day therapy with the drug can assist reverse infections.
There are 2 Phase 3 trials of the drug, one of which will not have results until the end of May. This very first data comes from a SIMPLE research study across 180 test sites worldwide, with Gilead concentrating on countries with a high frequency of COVID-19 infection.
That includes the US, UK, China, Sweden, and others. 397 patients were arbitrarily assigned to two groups, receiving a 200mg dosage of remdesivir on the first day, followed by fifty percent that dosage daily for either 5 or 10 days in total. The research study was just recently increased with more than 5,600 individuals.
Because what’s thought about “severe” infection can vary, Gilead standardized its participants for the initial round of the trials on clients revealing proof of pneumonia and decreased oxygen levels, yet that did not call for mechanical ventilation at the time the study started. In the growth of the Phase 3 test, it has now included people on mechanical ventilation.
More than half of all patients in both treatment groups were discharged from hospital by day 14. The time to clinical improvement – that is, “an improvement of two or more points from baseline on a predefined seven-point scale, ranging from hospital discharge to increasing levels of oxygen support to death” – for 50-percent of patients was 10 days in the 5-day group and 11 days in the 10-day group.
Further analysis of the results indicates earlier treatment is connected with better outcomes. Those patients who received remdesivir within 10 days of their symptoms appearing, for example, showed improved outcomes compared to those treated after 10 days from symptom onset.
Combining both the 5- and 10-day groups, by day 14 of treatment, 62-percent of those who had been dosed early were able to be discharged from the hospital. In contrast, 49-percent of patients treated late were ready for discharge.
Equally important, the actual length of treatment with the drug doesn’t seem to impact the outcomes significantly. “These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” one of the lead investigators in the study, Aruna Subramanian, MD, a Clinical Professor of Medicine and Chief of Immunocompromised Host Infectious Diseases at Stanford University School of Medicine, said.
That could have a significant impact on the availability of the drug, assuming it’s approved for widespread COVID-19 treatment. In early April, Gilead said it had approximately 1.5 million doses of the drug – enough, roughly, for more than 140,000 treatment courses. It had also been exploring new manufacturing processes, which, the company claimed, could trim the end-to-end manufacturing timeline from roughly a year to around six months.
Gilead has been developing remdesivir for several different viral pathogens, hence its ability to implement coronavirus clinical trials quickly. The drug has already shown broad-spectrum antiviral activity for diseases like Ebola, MERS, and SARS, albeit in animal models.
What’s still required is confirmation that it’s a safe treatment, and not likely to cause any significant side-effects should it roll out more broadly in hospitals. That’s the focus of the current Phase 3 trials.