On 2020-07-29 22:25:43, user P. J. wrote:
When you download the PDF, you will see all relevant info. ALL patients also got hydroxychloroquine and 3/7 also got azithromycin. Interestingly no heart issues, no deaths, better outcomes. Is it the combo...maybe? Honestly, I don't care as long as it works, but let's be up front about it.
Seven patients out of 7 received at least one dose of the study drug?? Only 3/7 even got the full treatment? (It looks like with an average length of stay of 14-24.5 days, there was plenty of time to complete a 14 day course, assuming treatment began on the first day.)
They do not give any breakdown of the drug group vs control as far as co-morbidities so they will need to do that going forward.
In the end, there were 5 patients. Not sure if all those were on HCQ, as they leave that out. Were any of the five on azithromycin? Who knows? It says "overall" 3 patients received the full course of the study drug. Ok, is that overall of the 7 that started, or the five little patients that remained? Let's ASSUME 3 of the final 5 got the full 14 days, plus maybe HCQ and maybe AZ? There was no statistical significance in the length of time weaning from HFNC to NC 02. Time to room air was about 1.5 days sooner...so 36 hours.
" Six patients in the control<br />
group (33%) required mechanical ventilation (p value compared with opaganib groups=0.13), 2(11%) required ECMO, and one required tracheostomy"
The drug group also had better D-dimer results and higher baseline lymphocytes going into the study which are both markers seen in patients who tend to have better outcomes, drugs or not. There was no difference in the rate of CRP improvement between the control and drug group. They couldn't measure true normalization of lymphocyte count because the control group received steroids.
Am I the only person routinely disappointed by the quietly buried info on HCQ? I think it was the RECOVERY remdesivir arm where patients weren't randomized until day 10-12 (well past the point where an antiviral would be of significant benefit) and 85% received HCQ up until starting remdesivir...and some even while taking it. A good number in the severely ill group were already maintaining O2 sats of 94% on room air when started on Remdesivir...in nursing, as far as oxygenation, we call that "stable." I don't know..maybe it's just me.
The results of this amazing new drug just aren't impressive when this sentence is included by the authors:
"In total, seven patients received at least one dose of opaganib since April 2, 2020. All<br />
patients received hydroxychloroquine (HCQ), however one stopped HCQ prior to opaganib<br />
treatment due to borderline Q-T interval in ECG. Three patients received azithromycin as well. One patient, who received both HCQ and azithromycin, developed diarrhea after two doses of opaganib, and the treating physicians decided to stop all his medications. A second patient who deemed to be in severe condition, was weaned to low flow oxygen within hours, and was discharged on RA (how long had he been on HCQ? Was he also on Azithromycin?) after receiving two doses of opaganib. Therefore, five patients were included<br />
in this analysis. Overall, 3 received the full 14-day course of opaganib, and 2 patients received 11 and 7 days respectively, before being discharged."
2/5 received 11 and 7 days of study drugs before being discharged. Were they discharged on the last day of treatment? I don't think so since discharges were from 14-24.5 days in the treatment group. Why was therapy discontinued before discharge? 15.2-29.5 days until discharge in control group. Not sure who fell where so hard to know if that was statistically significant or not. But, the rate of decline as far as needing ECMO or mechanical ventilation were good...maybe, I mean with better D-dimer (not sure how much better...no info there) And higher lymphocyte count at the onset of the study, (Again, not sure how much higher) It's hard to know if the drug helped, if the other drugs helped, or if those patients were more stable going in and would have recovered either way. It just feels like another non-study study. I also have no idea how big the control group was. OH wait, there's a table. I missed it. The control group is over 3x the size of the trial group...come on guys. The control group had 3-4x the comorbidities..so a stacked control group in number and chronic disease manifestation. Mean lymphocyte count in the control group was 850 vs. 1100 in the drug group. Other labs as listed in Table one when you click on the PDF, but overall, the control group was sicker.
I would be interested to know how the drug group (that got HCQ, study drug, and AZ) did vs the control group patients who got HCQ and AZ) That would actually be a more fair comparison...well maybe. I can't be sure since the control group was sicker and had more comorbidities to begin with.
I started this analysis wondering if there was an exciting new drug that could really help and I finish still wondering the same thing. I am beginning to question if any of these studies have people familiar with research standards running them. No randomization, no blinding, no real placebo control group, (I understand the ethics of having a "no treatment" group that truly gets "no treatment" and respect that all patients deserve treatment so placebo will always be a treatment group.)
Doctors on the drug company payroll or affiliated financially with the drug company, data analysis of trials and studies done by the sponsoring drug companies, writiing of studies by drug companies and or their employees rather than doctors without bias....I just find it all questionable.
I keep reading studies that leave out randomization, control group, blinding, etc. The inclusion of gold standard research methods could give us real scientific data. Why does the scientific community routinely fail to integrate the known gold standards in their studies? Do they feel their drugs wouldn't stand up to such rigor?