Can't do any better than JAMA for scientific/Medical info for those who think they know better.
Lol..easy shit to google
https://jamanetwork.com/journals/jama/fullarticle/2777389
Low usefulness underpowered ivermectin RCT in young patients published by JAMA. IVM arm shows: • lower mortality • lower disease progression • lower hospitalization or ICU or O2 need • faster symptom resolution but no stat significance due to design.
Let's start with a clinical trial golden rule: the population sample must reflect the population to treat in the real world. An absolute must. And an absolute design fail right from the start: this study has cherry-picked low-risk patients 6x less likely to die.
The study evaluates a treatment impact on a low-risk, young population that self-heals rapidly. The result is a very low event rate and lack of statistical power across the board. Only 2.8% of patients ever deteriorated, with a very sound Odds Ratio of 50% in the IVM arm.
Realizing the low event rate, the researchers modified nearly all the study's endpoints midway, moving the primary one to full symptom resolution by day 21. This is flawed in a largely self-healing cohort as outcomes converge over time: the "lenticular effect" described below
Second major issue: Patients were treated for only 5 days. Symptom resolution measured at 21 days. What? Why aren't people treated as long as they have symptoms? If IVM is short-acting, that design is worthless.
3rd major issue: the authors wrongly advised to take ivermectin on an empty stomach, reducing drug bioavailability in lung tissue by a factor 2.5.
Nonetheless, ivermectin shows a 9% faster daily symptom resolution (without statistical significance), decent given the hostile study design:
Another signal of efficacy is visible in the Adverse Events analysis: there are less AE in the ivermectin arm (76.7 vs 81.3%)! How can there be so many and more in the placebo arm? Because Covid-19 strikes panic in patients and the many symptoms match fear symptoms.
Fear having a large impact on symptomatology means that the primary endpoint is soft, subjective and partially psychological. Notably, the data in non-hospitalized patients (nearly all of them) was collected through a phone survey without physical medical examination. Not good.
There might be only one indirect indicator on the viral course of the disease in the study: fever. Odds Ratio of 0.73 in favour of the ivermectin arm.
Very unusually, the study reports that the pharmacist provided the control arm with ivermectin for a while "by mistake". But what if that was intentional to torpedo the trial? Without serum testing, how to be sure that those and only those meant to obtain IVM got it? Red flag.
A strong hint that the lack of stat significance is due to sample size rather than drug efficacy is shown by the Odd Ratio of symptom resolution at day 21 with/without the control arm patients treated with IVM: • without (200): 1.23 [0.75-2.01] • with (275): 1.46 [0.91-2.34]
On the conflict of interest front, we have a full slate, with the authors getting money from: • Glaxo • Sanofi Pasteur (yes, the vaccine people) • Janssen (J&J vaccine partner) • Merck (ivermectin hater) • Gilead (remdesivir peddler)
Sadly, the authors falsely state that: "preliminary reports of other randomized trials of ivermectin as treatment for COVID-19 with positive results have not yet been published in peer-reviewed journals" Another red flag.
-@Covid19Crusher
https://threadreaderapp.com/thread/1367854831076061185.html