Not an expert but let's look at it - Clinical I
Post# of 155038
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Posted On: 07/31/2020 3:41:29 AM
Not an expert but let's look at it -
This will be the hardest one to beat because the time point is only at 14 days and most patients at least in mild will resolve symptoms by 14 days. What gives it some weight in favor of leronlimab is the 12 point system. I would expect the vast majority on leronlimab will have a zero or near zero score.
With an even spread from mild to moderate I would expect statistically significant but not by much. What may tilt it in our favor is it is more likely that those with moderate rather than mild symptoms would go to the hospital. With moderate including those with double pneumonia at that end we'd have a very nice p value.
With the four secondary outcomes with testing occuring at 3, 7 and 14 days we should handily beat them all because we know how fast leronlimab can work.
The one thing to keep in mind is that we will be compared against the SOC (remdesivir) who's approval was based solely on average recovery time of 11 days. I would expect ours to average around 7, less than half of placebo. We certainly won't have a 7.1% mortality rate. These tests don't match up completely since the remdesivir trial was a combination of mild/moderate/severe but not critical.
Quote:
Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [ Time Frame: Day 14 ]
Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. [0=none, 1=mild, 2=moderate, and 3=severe]. Higher scores mean a worse outcome.
This will be the hardest one to beat because the time point is only at 14 days and most patients at least in mild will resolve symptoms by 14 days. What gives it some weight in favor of leronlimab is the 12 point system. I would expect the vast majority on leronlimab will have a zero or near zero score.
With an even spread from mild to moderate I would expect statistically significant but not by much. What may tilt it in our favor is it is more likely that those with moderate rather than mild symptoms would go to the hospital. With moderate including those with double pneumonia at that end we'd have a very nice p value.
With the four secondary outcomes with testing occuring at 3, 7 and 14 days we should handily beat them all because we know how fast leronlimab can work.
The one thing to keep in mind is that we will be compared against the SOC (remdesivir) who's approval was based solely on average recovery time of 11 days. I would expect ours to average around 7, less than half of placebo. We certainly won't have a 7.1% mortality rate. These tests don't match up completely since the remdesivir trial was a combination of mild/moderate/severe but not critical.
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