Regeneron recently presnted results from the Phase 3 pivotal trial showing REGEN‑COV™ (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death, shortened symptom duration and reduced viral load in non-hospitalized patients with COVID-19.
DocWire News spoke with Julie Philley, MD, Chair of Internal Medicine at the University of Texas Health Science Center and trial investigator, to discuss the findings.
DocWire News: Can you detail for us how this study was conducted and what were the findings?
Dr. Julie Philley: Sure. Well, thanks. First of all, this was a completely outpatient trial. Looking at patients, if we can catch them early enough, can you prevent patients with COVID from going on to needing hospitalization and/or death? This was conducted in patients that were tested positive for COVID, had symptoms within seven days of onset, and then were not on oxygen, so their SPO2 was 93 percent or greater. So they received this cocktail, and what we found was really impressive, and that is receiving this cocktail as a one-time IV-dose in the outpatient setting reduced hospitalization and death by a little over 70 percent.
DocWire News: Did any of the results surpise you?
Dr. Julie Philley: Well, I think we’ve all known as physicians that probably intervening early is better, especially for these types of patients. But I think I was shocked to see the robust nature of this, and clinically saw people improve with this cocktail. So yes, I thought the results were shocking.
DocWire News: Did this study have any limitations?
In terms of limitations, again, I think we ask ourselves these questions about when do you intervene and what can make a real impact? I think that this study was, first of all, it was safe. A lot of patients were enrolled. There were no major side effects noted, and so I think that the results were robust and the study was safe for patients. In terms of limitations, I’d just say we still try to keep working to find the right cocktails to work the best that they can as early as possible.
DocWire News: What are the overall clinical implications of these findings?
Dr. Julie Philley: Well, clinically, listen, if you can prevent one from being hospitalized, certainly from passing away from COVID, it’s a significant impact. So the earlier you can catch these patients, enroll them and give them a cocktail such as this, which is approved, then it can prevent people from going on to being hospitalized with all of those implications and then from dying from COVID. It’s a really, really big deal.
DocWire News: What’s the key takeaway message of this study?
Dr. Julie Philley: I think the takeaway is that when you identify a patient with COVID early on, that there’s a treatment option that’s available to them that really has significant impact.