/sci/ - Science & Math

>>11483636
Guys I know the results *appear* amazing, but it's one of the most poorly conducted clinical trials I've ever seen, to the point of being useless. I'll explain why.

Per the methods the study started with 26 pts in the HCQ group and 16 control. Then why only 20 HCQ pts in the analysis? Because in order to be in the cohort you had to be evaluable (swab) at day 6. That meant 6 HCQ pts were ineligible.

What happened to those six HCQ patients?
- 3 were transferred to the ICU while still PCR positive
- 1 died (PCR negative)
- 1 left the hospital (PCR negative)
- 1 withdrew due to nausea (PCR positive)
I dunno- seems to me like 5 failures to me.

But the real good stuff is in this table. Just to orient you: top 16 patients control, next 14 HCQ monotherapy, last 6 HCQ+AZ. Look at the last 7 columns. These are Ct values at baseline (day zero) and through the six days of the study. The cycle threshold (Ct) is the number of cycles to be run for the PCR test to turn positive. Bottom line the LOWER the number the more virus that is present; that is, the less number of cycles to hit threshold. For combo therapy all patients have baseline Ct values of 24 or higher, whereas 5 patients in the monotherapy arm have values < 23 (in particular 15, 17, 19, 22, 22). It means there was a chunk of pts in the monotherapy arm who would need a greater antiviral effect to reach "negative" or undetectable virus. In this analysis negative was defined as Ct>35. It's also notable that negative is often defined at Ct>40. Even more troubling, in the control group, for all but 4 (!!!) patients, PCRs were never even run and virus presence was determined qualitatively!

So did this impact the outcomes between monotherapy and combo therapy? You tell me. Eradication rates at day 6:
HCQ monotherapy (Ct <23): 1/5 (20%)
HCQ monotherapy (Ct 23+): 7/9 (78%)
HCQ + Azithro (all Ct 24+): 6/6 (100%)