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Originally Posted by AfricanSunset
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For those who want my takeaways from this study,
Most of the infections happened during the period of Omicron. Omicron is a far milder virus, resulting in 1:100-1:1000 the hospitalization rates as earlier variants. This makes the study's power too small. They did see improvements in the Ivermectin arm, but due to being underpowered, no result here could reach statistical significance. Basically, the study needed more power.
But there was a tendency of Ivermectin to improve clinical outcomes even though they were not statistically significant.
1. The hazard ratio (HR) for improvement in time to recovery was 1.07 (95% credible interval [CrI], 0.96-1.17
2. The most common serious adverse events were COVID-19 pneumonia (ivermectin [n = 5]; placebo [n = 7]) and venous thromboembolism (ivermectin [n = 1]; placebo [n = 5]).
Then there is this here sentence:
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The median time from symptom onset to receipt of study drug was 6 days (IQR, 4-8).
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These patients were sick for 6 days before getting the treatments. 6 days is way too late, the virus is already done replicated, what's left is just viral debris and immune dysregulation.
Take note that recovery time requires 3 days of consecutive no symptoms, so for 12 days, that means on the 9th day of receiving the drug, they had no symptoms. For placebo this was 10 days.
If you go to eFigure 3 in the appendix, for those experiencing severe symptoms and got Ivermectin on day 1, HR 1.86 (1.10 to 3.36). This is subgroup analysis and don't put too much weight in it, but it's interesting. So, time to recovery was 86% longer on placebo vs active (IVM) in this case.
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Exclusion criteria included hospitalization, study drug use within 14 days, or known allergy or contraindication to study drug (Supplement 1). Vaccination was allowable, as were standard-of-care therapies for COVID-19.
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What this sentence means, patients were excluded from the trial if they were hospitalized. So more severe cases of COVID19 would be excluded. On top of that, they were receiving other drugs (SOC) as well as Ivermectin or Placebo, which further complicates the analysis.
Which brings me to their other statistically significant finding:
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or the ordinal outcome at day 14, the difference in the amount of time spent feeling unwell with COVID-19 was estimated to be 0.49 days (95% CrI, 0.15-0.82 days) in favor of ivermectin.
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So my conclusion, in Omicron, Ivermectin works very very little, mostly because Omicron is very very mild.
Also, I want to know what 'placebo' the trial participants got, they mention an 'matched' placebo, and then there is this endpoint:
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Adverse events were uncommon and similar in both groups (2.8% with ivermectin; 3.5% with placebo).
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More people taking a placebo had adverse events. Weird.
They also did not get a sufficient dose of Ivermectin:
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Third, ivermectin was dosed by weight to achieve a goal dose of 400 μg/kg, but the maximum dose of ivermectin provided by the study was 35 mg.
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Given the obesity, around 50% of the Ivermectin arm was under-dosed.