OT: COVID Science - Pfizer/Moderna vaccines >90% effective; Regeneron antibody cocktail looks very promising in phase II/III trial and more

bac2therac

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I trashed it because yeah, I do know better in this case and so does the medical community, which will trash it once they see it, since they know that the Boulware/Mitja RCTs on mildly ill patients are far more relevant than this crappy "recommendation" (it's not even a study) and they'll laugh their asses off when they see the "paper" didn't even mention these RCTs.
Laughing it off sounds so full of science
 

pmvon

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I am not say it isnt deadly by any means. I worked in hospitals in the beginning as saw how jammed they were. I know it is real. However even on the CDC website it has over 12,000 deaths from Intentional and unintentional injury, poisoning and other adverse events that is counted as a Covid death. Has nothing to do with the letter Q
Ok so reduce the number by 12k. What does that mean and why make the argument? It does contribute to the hoax conspiracy theory.
 

fsg2

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Wait a peer reviewed study in a major medical journal
Wait ...a yearlong Hansel & Gretel trail of deleted fake news, walked back tweets and sound bites that required subsequent apologies.

Even if you were to cite a flawless source, no one would read it until someone else posted it. Because you have sub-zero credibility. Why don't you get that?
 

RU848789

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Wait a peer reviewed study in a major medical journal
It's "peer reviewed" but that is nowhere near a major medical journal - the Elsevier journals are considered, collectively to be fairly lightweight by serious scientists. Again, I'm not making this stuff up. I guarantee you that paper will make zero impact, given the far more rigorous RCTs that have already been completed on that patient population, showing no clinical benefit. This is not hard stuff, but you simply don't seem willing to learn or listen to scientific experts.
 
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cohwx

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Anyone who has been following the controversy regarding ivermectin might be interested in this video. I don't particularly care for some of the views of the host (James Lyons-Weiler) but most of the video is a presentation by Pierre Kory. I don't claim to know what the "truth" is regarding ivermectin but the evidence he presents seems pretty solid and the NIH has even changed their guidelines from "not recommended" to "neither for nor against". Baby steps... From what I'm hearing the WHO is looking at the ivermectin studies in detail and we may be seeing significant changes in guidance before long.

Anyway...Pierre Kory on ivermection (Jan 16)
 

ArminRU

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Article said we'd have trial data by the last week in Jan or the first week in Feb, which I don't think is a change - that's when we'll see press releases. Just like for Pfizer/Moderna, it'll take a few weeks to a month to get an EUA.
I read it that they’ll start the analysis sometime in the next few weeks. If efficacy will hit the press shortly after that, then that’s good. Was thinking we’d have to wait another 2 weeks once they finish the analysis.
 
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RU848789

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Anyone who has been following the controversy regarding ivermectin might be interested in this video. I don't particularly care for some of the views of the host (James Lyons-Weiler) but most of the video is a presentation by Pierre Kory. I don't claim to know what the "truth" is regarding ivermectin but the evidence he presents seems pretty solid and the NIH has even changed their guidelines from "not recommended" to "neither for nor against". Baby steps... From what I'm hearing the WHO is looking at the ivermectin studies in detail and we may be seeing significant changes in guidance before long.

Anyway...Pierre Kory on ivermection (Jan 16)
Ivermectin is looking a bit like HCQ looked to me (scientifically, not politically) before the larger RCTs were completed, i.e., it shows mixed results across a bunch of clinical trials, which is what often happens when a drug is ineffective and the trials are small and not always well controlled, as per the NIH guidance, below.

As I've said before, having worked on this drug very early in my career, I'd love to see it truly be effective, but I'm skeptical, as it's an anti-parasitic being used as an antiviral. We need a well run large randomized, controlled trial (like the ones that have been run on the monoclonal antibodies or HCQ) to make some sense of all this. It's disappointing to me, at least, that most of the "breakthrough" COVID clinical trials have been in the UK and not in the US (on HCQ, dexamethasone, lopinavir/ritonavir, etc.).

And as if on cue, a small (24 patients) randomized, controlled trial was just published showing encouraging, but not statistically significant benefits from ivermectin in very mildly ill COVID patients. The study says we need larger RCTs to determine if ivermectin is effective or not. Sounds familiar.

https://www.covid19treatmentguidelines.nih.gov/statement-on-ivermectin/

Since the last revision of the Ivermectin section of the Guidelines, the results of several randomized trials and retrospective cohort studies of ivermectin use in patients with COVID-19 have been published in peer-reviewed journals or made available as preliminary, non-peer-reviewed reports. Some clinical studies showed no benefits or worsening of disease after ivermectin use,11-14 whereas others reported shorter time to resolution of disease manifestations attributed to COVID-19,15-18 greater reduction in inflammatory markers,16,17 shorter time to viral clearance,11,16 or lower mortality rates in patients who received ivermectin than in patients who received comparator drugs or placebo.11,16,18

However, most of the studies reported to date had incomplete information and significant methodological limitations, which make it difficult to exclude common causes of bias. The missing information and limitations include the following:

  • The sample size of most of the trials was small.
  • Various doses and schedules of ivermectin were used.
  • Some of the randomized controlled trials were open-label studies in which neither the participants nor the investigators were blinded to the treatment arms.
  • In addition to ivermectin or the comparator drug, patients also received various concomitant medications (e.g., doxycycline, hydroxychloroquine, azithromycin, zinc, corticosteroids), confounding assessment of the true efficacy or safety of ivermectin.
  • The severity of COVID-19 in the study participants was not always well described.
  • The study outcome measures were not always clearly defined.
Because of these limitations, the Panel cannot draw definitive conclusions about the clinical efficacy or safety of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin for the treatment of COVID-19.
 

RU848789

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I read it that they’ll start the analysis sometime in the next few weeks. If efficacy will hit the press shortly after that, then that’s good. Was thinking we’d have to wait another 2 weeks once they finish the analysis.
To be clear, what will happen, assuming this goes like the other vaccines, is that the data will be unblinded to the company in the next 2 weeks and they'll do a quick analysis and issue a press release. The company will then do a much more thorough data analysis and put together their case for why an EUA should be issued and then meet with the FDA, probably in late February on that. The FDA will then likely take several days to a week (depending on how strong the data look) to approve the EUA (or not, which usually means a company has to gather more data, not that the vaccine is dead, unless there were simply no efficacy, which nobody expects given the immune responses in the early trials).