Itolizumab: "Biocon conducted a randomized, con
Post# of 154066
(Total Views: 647)
Posted On: 08/17/2020 5:42:06 PM
Itolizumab:
"Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS. Twenty patients were randomized to receive itolizumab plus best supportive care, while 10 patients received best supportive care alone. The primary endpoint was mortality at one month. As reported by Biocon:
In the itolizumab arm there were no deaths and all patients have recovered; in the control arm three patients died and the remainder have recovered
The mortality benefit observed in the itolizumab arm was statistically significant"
It was a small, randomized, placebo controlled trial. Open label, as I mentioned.
It sounds like you think the blinded part is very important, but I don't think there would be a placebo effect of those knowing they got itolizumab to survive just because they know they got it, do you?
For the dexamethasone study, I don't believe N=1500 is small, do you?
"Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001)."
Anyways, we may be the first DBRPCT to show mortality benefit, but not the first RPCT to do so. I don't think there is a placebo effect on death in Covid, so blinding shouldn't effect the outcome as far as I am concerned.
Again, it may be nit-picking, but I think it's important to be accurate and avoid exaggeration. Makes us an easy target, and we sure don't need any more of that.
"Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS. Twenty patients were randomized to receive itolizumab plus best supportive care, while 10 patients received best supportive care alone. The primary endpoint was mortality at one month. As reported by Biocon:
In the itolizumab arm there were no deaths and all patients have recovered; in the control arm three patients died and the remainder have recovered
The mortality benefit observed in the itolizumab arm was statistically significant"
It was a small, randomized, placebo controlled trial. Open label, as I mentioned.
It sounds like you think the blinded part is very important, but I don't think there would be a placebo effect of those knowing they got itolizumab to survive just because they know they got it, do you?
For the dexamethasone study, I don't believe N=1500 is small, do you?
"Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001)."
Anyways, we may be the first DBRPCT to show mortality benefit, but not the first RPCT to do so. I don't think there is a placebo effect on death in Covid, so blinding shouldn't effect the outcome as far as I am concerned.
Again, it may be nit-picking, but I think it's important to be accurate and avoid exaggeration. Makes us an easy target, and we sure don't need any more of that.
(5)
(0)