Jaylimab, looking at the clinical trials pages,
1. Brazil trials consider people requiring non-invasive ventilation or high flow oxygen as "moderately ill". And only those who are on ECMO are critical.
2. Where did cd12 put people requiring non-invasive ventilation? It clubbed them in the same group as Critical. The severe in that trial required that patient should NOT have "ECMO, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations"
So what does this mean? What we call "moderately ill" includes a major sub-group of those who were considered Critical in cd12.
The Need for Oxygen is the key indication. We are isolating that criterion into lesser and greater categories, i.e those who are a. hospitalized and requiring supplemental oxygen or high flow, non-invasive ventilation, or b. on ECMO.
In cd12, most of both these categories were considered part of Critical. In Brazil, we are focusing on this group primarily but splitting it up into two.
That also means that we are not focusing on the many other cd12 type "severe" patients who are neither here nor there and may be severe for reasons not related to what we think is Leronlimab's MOA. The Brazil trials have refined criteria that tries to weed them out. For example, we want patients who entered the "moderately ill" or the "Critical" phases within 72 hours prior to LL treatment and who have low probability of dying within 48 hours of study inclusion. So a patient may be suffering for a while, with some serious organ failure, doctors know there is little to no chance; yet cd12 may have considered that patient as eligible. In Brazil, we would be saying "NO" to including such a patient.
So, we got not so good results for "severe" in cd12 possibly because the patients were too broadly selected, and now we have refined the selection process. And in fact, the refinement is really focused on the "critical" of cd12 where we got the good results.
