TrumpLyftAlles | 2 points | Nov 04 2020 19:41:27

Effectiveness of Ivermectin as add-on Therapy in COVID-19 Management (Iraq 2020-11-04) Trial results: N=16, one arm, IVM + HCQ + AZT, mean days to cure = 7.62

https://clinicaltrials.gov/ct2/show/results/NCT04343092?term=ivermectin&recrs=e&rslt=With&cond=covid&draw=2&rank=3

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[-] TrumpLyftAlles | 1 points | Nov 04 2020 20:19:15

Move along, nothing to see here. {Big sigh emoji}

This isn't a win or loss for ivermectin; it's a crap study that reports a single meaningless number. Please correct me if I'm wrong.

It's the 5th trial in ClinicalTrials with status "Completed - Has Results".

TL;DR: For 16 patients given 1 dose of ivermectin + 6 days of HCQ + AZT, the average time from admission to being free of symptoms and getting 2 PCR-negative tests was 7.62 days (2.75).

N=16, no control arm, no masking.

Subjects had a "definite Dx" (diagnosis, I guess) of covid19. There's no indication that a PCR was involved in establishing that. The method is not specified.

Treatment:

IVM 0.2mg /kg single dose at admisison day HCQ 400mg BID in the first day then 200mg BID for 5 days AZT 500mg in the first day then 250mg for 5 days

Weird: 1 minimal dose of IVM, plus 6 days for each of HCQ and AZT. Why do we never see discrimination in the other direction? More IVM than HCQ? Do they have more HCQ on the shelves, than IVM?

I have seen more advocacy of using IVM + HCQ together, on twitter, which of course has no scientific import.

Primary outcome is assessed by calculating the number of patients who had symptoms free and two successive readings of negative PCR swab.

Arm description:

Time to cure in IVM+HCQ+AZT group and evaluated by measuring time from admission of the patient to the hospital till discharge after being free of symptoms and negative PCR swab. Once nasopharyngeal and oropharyngeal swab viral PCR testing yielded negative results 2 times consecutively, no further testing was performed.

Secondary outcome (4-week timeframe):

Time to cure is evaluated by measuring time from admission of the patient to the hospital till discharge after being free of symptoms and negative PCR swab. Once nasopharyngeal and oropharyngeal swab viral PCR testing yielded negative results 2 times consecutively, no further testing was performed

That's the same as the primary arm description.

Outcome measure data:

# Days: 7.62 (2.75)

That's it, the only result reported by this study.

No one died and there were no serious adverse effects.

According to ClinicalTrials, this study was started on April 18, was completed on June 1, and finally reported today. Grrrrr: why does it take so friggin' long?.

Looking at the trial history, it originally had TWO arms:]

That would have been useful: does IVM make HCQ + AZT more effective? It was originally double-blind, too, with N=50. Why did it end up with 1 arm and N=16? Is this the trial for which ClinicalTrials rejected the results, over and over? I wonder if Dr. Gorial cut the study to shreds just to get ClinicalTrials to accept the results.

This study tells us essentially nothing, as far as I can tell. The stand-alone number, 7.62 days, tells us nothing since there's nothing to compare it to.

It's like the kid who waited until the last minute to get his paper done, so he changed the subject from "Rise and Fall of the Roman Empire" to "Pizza in the Time of Caesar".

TLATODO: Compare it to the first Iraq study, which IIRC was IVM + DOXY vs HCQ + AZT. Which ever study compared those two.

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