- Data from a new coronavirus drug trial shows that a 5-day course of remdesivir therapy is more effective than standard care, and works just as well as a 10-day course.
- The results only apply to a specific set of COVID-19 patients, namely people who developed a moderate case, which included pneumonia without reduced oxygen levels.
- The new Phase 3 SIMPLE remdesivir study indirectly suggests the drug won’t work in severe cases, and it will not affect COVID-19 mortality rates. The results are in line with a previously published trial.
The novel coronavirus still has no cure, but doctors have devised plenty of therapies that have shown promise and are in various stages of testing. One of them is remdesivir, the drug that received Dr. Anthony Fauci’s endorsement in late April. We learned at the time that remdesivir can speed up recovery, reducing it down from 15 days with other types of care to 11 days. Fauci said at the time that the drug didn’t affect mortality rates and that remdesivir may have to be combined with different medicine to improve COVID-19 therapy.
The study was published a few weeks later, further confirming these findings, and making it clear that remdesivir isn’t the miracle COVID-19 drug we’ve been waiting for. The maker of remdesivir on Monday published an additional study on Monday that says that remdesivir works in COVID-19 therapies. However, Gilead’s Phase 3 study assessed the length of treatment, and its conclusions may only apply to a certain subset of patients.
Gilead’s announcement doesn’t come in the form of a study, which will be published at a later date, but it still has plenty of interesting data. Gilead compared 5-day and 10-day courses of remdesivir plus standard of care against standard of care alone by dividing patients into three groups. The data showed that patients in the 5-day group were 65% more likely to have clinical improvements on Day 11 compared to those in the standard care group. The 10-day course did not show improvements that were statistically significant compared to standard care, but Gilead says the odds of improvement were favorable, “trending towards” significance.
The study included 600 patients with moderate COVID-19 cases, including pneumonia, without reduced oxygen levels. They were randomized 1:1:1. “The primary endpoint was the clinical status as assessed by a 7-point ordinal score on Day 11, ranging from hospital discharge to increasing levels of oxygen and ventilatory support to death,” the announcement reads. “The secondary study objective was the rate of adverse events in each remdesivir treatment group compared with standard of care.”
Gilead says that a higher proportion of patients in the 5-day cohort achieved improvements in clinical status versus standard care. The company also says that “non-statistically significant increases in clinical worsening or death were observed in the standard of care only group compared with the remdesivir groups.”
As for the side effects, the drug was well-tolerated, and the most adverse effects in more than 5% in both groups included nausea and headache. Four people in the control group died, compared to two in the 10-day cohort. There were no fatalities in the 5-day group.
In other words, remdesivir therapy can be helpful, but there’s still no evidence that the drug can prevent complications, which is a key objective for COVID-19 treatments. Even so, access to remdesivir may speed up recovery for some patients. “These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients,” Harvard Medical School professor and Brigham and Women’s Hospital infectious disease physician Francisco Marty said in a statement.
Also, the study seems to indicate that a 5-day course of intravenous remdesivir may work just as well as a 10-day course of treatment. If anything, these results are good news for hospitals that are looking to ration remdesivir, a drug that’s not widely available. A second phase of the study added up to 1,000 additional patients with moderate manifestations, and the results will be available in the coming months.
Gilead noted in a separate statement that a SIMPLE-Severe study of the drug that included COVID-19 patients who require non-invasive supplemental oxygen showed that a 5-day remdesivir course led to similar improvements as a 10-day course.
As CNBC points out, the modest benefits against the coronavirus will fuel further skepticism regarding remdesivir. Gilead’s shares fell 4% after the results were published.