jpdowlin | 19 points | Jul 08 2020 16:07:52

Baghdad study results out

https://www.medrxiv.org/content/10.1101/2020.07.07.20145979v1.full.pdf

Brief highlights here:

https://twitter.com/jim_dowling/status/1280894091274981376

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[-] TrumpLyftAlles | 4 points | Jul 08 2020 16:47:39

A good result, but unfortunately all it shows is that ivermectin + HCQ + AZT is probably more effective than HCQ + AZT. The three-drug protocol is used in several places, esp. in Latin America, so now they have a trial supporting that practice, a good thing.

Elsewhere, though, HCQ is being disparaged, e.g. WHO ended the HCQ arm of its massive SOLIDARITY study 4 days ago. So this study shows that ivermectin improves the effectiveness of a therapy that WHO and others are rejecting.

I haven't looked at it closely, but my sense is that the rejection of HCQ is premature. This study will be more important if subsequent studies endorse HCQ + AZT. ClinicalTrials has 87 trials looking at HCQ + AZT, 5 of which are completed, including this one. The truth will be known.

It doesn't help that nearly everyone survived in this trial, 100% vs 97.2%.

The difference in length of stay with ivermectin is huge, 7.62 days 13.22, a very statistically significant result at p=0.00005. If I was an MD making decisions about drug therapy, this alone would be great motivation to try ivermectin, regardless of its other alleged benefits.

Abstract

Background: To date no effective therapy has been demonstrated for COVID-19. In vitro, studies indicated that ivermectin (IVM) has antiviral effect.

Objectives: To assess the effectiveness of ivermectin (IVM) as add-on therapy to hydroxychloroquine (HCQ) and azithromycin (AZT) in treatment of COVID-19.

Methods: This Pilot clinical trial conducted on hospitalized adult patients with mild to moderate COVID-19 diagnosed according to WHO interim guidance. Sixteen Patients received a single dose of IVM 200Mcg /kg on admission day as add on therapy to hydroxychloroquine ( HCQ)and Azithromycin (AZT) and were compared with 71 controls received HCQ and AZT matched in age, gender, clinical features, and comorbidities. The primary outcome was percentage of cured patients, defined as symptoms free to be discharged from the hospital and 2 consecutive negative PCR test from nasopharyngeal swabs at least 24 hours apart. The secondary outcomes were time to cure in both groups and evaluated by measuring time from admission of the patient to the hospital till discharge.

Results: Of 87 patients included in the study,t he mean age ± SD (range) of patients in the IVM group was similar to controls [44.87 ± 10.64 (28-60) vs 45.23 ± 18.47 (8-80) years, p=0.78] Majority of patients in both groups were male but statistically not significant [11(69%) versus 52 (73%), with male: female ratio 2.21 versus 2.7-, p=0.72) All the patients of IVM group were cured compared with the controls [ 16 (100 %) vs 69 (97.2 %)]. Two patients died in the controls. The mean time to stay in the hospital was significantly lower in IVM group compared with the controls (7.62 ±2.75 versus 13.22 ±.90 days, p=0.00005, effect size= 0.82). No adverse events were observed

Conclusions : Add-on use of IVM to HCQ and AZT had better effectiveness, shorter hospital stay, and relatively safe compared with controls. however, a larger prospective study with longer follow up may be needed to validate these results.

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[-] fyodor32768 | 6 points | Jul 08 2020 19:06:35

It seems a lot more likely that if there's an effect, it's coming from the Ivermectin, not some special IVM+HCQ synergy. The reason that they used HCQ was that once there's a standard of care, you always include it so as to avoid potential harm, not because they think that there's some magic synergy between HCQ and Ivermectin. For example, the Famotidine study switched from Famotidine+HCQ to Famotidine +Remdesivir because Remdesivir became the new standard of care.

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[-] TrumpLyftAlles | -1 points | Jul 08 2020 19:12:25

But HCQ + AZT was so effective without ivermectin -- at least in preventing fatalities, if not length of stay.

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[-] Gorangers0525 | 3 points | Jul 08 2020 19:18:01

What RCT showed HCQ+AZT effective in preventing fatalities? Not being a jerk, just seriously curious as all the ones I've seen have shown no significant reduction in mortality and higher risk of side effects.

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[-] TrumpLyftAlles | 1 points | Jul 08 2020 19:33:19

What RCT showed HCQ+AZT effective in preventing fatalities?

This one: 2.8% fatalities.

Of course, there's no control arm so it's impossible to know how many patients would have died without the drug treatment.

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[-] Gorangers0525 | 3 points | Jul 08 2020 20:51:17

2.8% fatalities would be pretty normal considering the trial consists of mild-moderate cases.

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[-] TrumpLyftAlles | 1 points | Jul 08 2020 20:57:06

Good point. It's hard to know, without details about the patients. That's why a control arm would have been really helpful.

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[-] DZinni | 4 points | Jul 08 2020 18:35:33

Regarding the survivability of the two drugs. 16 is not a big enough sample size to assure that ivermectin increases survivability. Lets assume the rate is the same. There would be a (.972)^(16)=63.4% chance of randomly drawing 16 survivors.

The difference in the recovery time is huge and likely significant even with the small sample size (would need to see the spread of recovery times to know for sure).

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[-] TrumpLyftAlles | 2 points | Jul 08 2020 19:15:00

Regarding the survivability of the two drugs. 16 is not a big enough sample size to assure that ivermectin increases survivability.

Totally agree. This is why it is so annoying when studies use such small N's. We're waiting on ivermectin studies that say they are going to treat 10 and 12 patients. Why bother, I wonder? Unless you're trying to undercut ivermectin by finding yet another "No significant effect" result. :(

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[-] covid-19_throwaway | 2 points | Jul 08 2020 17:47:10

I'm unsure whether HCQ has a lot of future as a COVID drug or not, and would rather it wasn't used in both arms of the trial, but this is a start. The difference in recovery time alone should be enough to make Gilead shareholders nervous.

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[-] TrumpLyftAlles | 3 points | Jul 08 2020 18:07:52

Even if WHO and the US medical establishment don't like it, HCQ is being used lots of places, in part because it's cheap. If they are ever completed, there are 82 trials yet to report. I won't be surprised if we eventually arrive at "Use HCQ unless contraindicated by the following heart conditions: ...".

The difference in recovery time alone should be enough to make Gilead shareholders nervous.

Isn't that the "big" (so-called) win with remdesivir? A 4-day shorter length of stay? I guess that's worth big $$$$ in the US health care system. If ivermectin ever catches on in the US, bye-bye remdesivir.

I wonder if Gilead has/will fund an anti-ivermectin campaign. That would be a smart tactic.

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[-] fyodor32768 | 2 points | Jul 08 2020 19:08:18

Gilead isn't making much money on Remdesivir and can't make enough of it to meet expected demand. And even if there's something new, we're going to be throwing everything at this until a vaccine comes.

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[-] TrumpLyftAlles | 1 points | Jul 08 2020 19:11:03

Good to know, thanks. I hate being over-cynical all the time.

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[-] vtron | 2 points | Jul 11 2020 13:43:44

From what I've read, if remdesiver was cheaper and easier to administer, the pandemic would basically be over. Unfortunately, we only have enough for the very sick and it can only be administered in a hospital (so again, it's only given to the very sick).

If we could give it to people early in the disease progression, it would be a gamechanger.

I'm hoping Ivermectin can be that gamechanger.

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[-] pezo1919 | 2 points | Jul 08 2020 19:12:40

Wait wait wait wait!

WHO is only stopping the Solidarity's HCQ where they are ridiculously overdosing the patients. It does not mean anything at all. WHO = China, they want the West the fall, that's all.

At this point it is quite sure both HCQ and ivermectin do work, standalone.

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[-] TrumpLyftAlles | 1 points | Jul 08 2020 19:13:23

At this point it is quite sure both HCQ and ivermectin do work, standalone.

Sounds plausible to me, but I know very little about HCQ.

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[-] pezo1919 | 2 points | Jul 08 2020 19:17:38

Yeah it is a long story too. But there are many studies from the past 2 weeks which are robust enough to rely on + the way BigPharma and WHO were attacking it through made up studies and fake data + publisher help (Lancet, NEJM) is beyond words... It might be hard to believe, but I was constantly checking the news on it until recently, because now I am really quite sure it's working. Even in the Long Haulers FB Group I asked the question did it work for anyone and MANY people said it DID help a lot for them.

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[-] TrumpLyftAlles | 2 points | Jul 08 2020 19:34:34

I keep chancing across positive results too. Can't be bothered to figure it out, though; too ivermectin-focused.

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[-] pezo1919 | 1 points | Jul 08 2020 19:35:27

I see, you really dug into it. I'll send you the best HCQ studies if I see them again.

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[-] TrumpLyftAlles | 1 points | Jul 08 2020 19:40:20

I'll send you the best HCQ studies if I see them again.

Thanks but no thanks. I'm only interested in ivermectin. YOU could create /r/hcq (if it doesn't aleady exist)! I'll drop by. :)

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[-] strongerthrulife | 4 points | Jul 08 2020 17:45:00

Is this posted in COVID-19?

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[-] vtron | 5 points | Jul 08 2020 17:54:36

Yup

https://www.reddit.com/r/COVID19/comments/hnk5hw/effectiveness_of_ivermectin_as_addon_therapy_in/

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[-] nabarkau | 3 points | Jul 08 2020 16:19:26

Superb. Hope mainstream media picks this now.

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[-] movethroughit | 3 points | Jul 08 2020 16:27:31

"Intervention Patients received IVM 200 Mcg single dose at the admission day... "

Should be 200mcg/kg as mentioned in the abstract?

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[-] TrumpLyftAlles | 1 points | Jul 09 2020 01:56:05

Yes. Where did you see it without the /kg?

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[-] movethroughit | 1 points | Jul 09 2020 02:31:44

Third page, third paragraph titled "Intervention" in bold.

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[-] TrumpLyftAlles | 2 points | Jul 09 2020 02:48:22

Intervention

Patients received IVM 200 Mcg single dose at the admission day as add on therapy to Iraqi Ministry of Health protocol for treatment of mild to moderate COVID-19 [ HCQ 400mg BID for the first day then 200mg BID for 5 days plus AZT 500mg single dose in the first day then 250mg for 5 days].

My you're a careful reader! Kudos!

On page 1:

Methods: This Pilot clinical trial conducted on hospitalized adult patients with mild to moderate COVID-19 diagnosed according to WHO interim guidance. Sixteen Patients received a single dose of IVM 200Mcg /kg on admission day...

Which is it? 200mcg/kg or 400mcg/kg, that day 1 dose?

That's the nature of preprints, I guess. Editing errors happen.

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[-] stereomatch | 3 points | Jul 09 2020 04:32:58

The 400mg figure is for HCQ first day dose. It is 400mg BID - which suggests it is 400mg twice on first day ie 800mg total, and then 200mg BID for 5 days ie 200mg twice a day (total 400mg) for 5 days. Other language used in prescriptions:

https://www.spineuniverse.com/treatments/medication/understanding-your-prescription

bid - twice a day po - by mouth

The Ivermection dose seems consistently 200mcg/kg (though missing kg in one place as comment above pointed out) - and was a one-time dose.

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[-] TrumpLyftAlles | 2 points | Jul 09 2020 04:42:32

Good catch, thanks. I must be too tired.

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[-] movethroughit | 2 points | Jul 09 2020 02:49:26

Yes indeed.

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[-] fyodor32768 | 3 points | Jul 08 2020 19:09:45

This is good news and I hope it's validated by the other studies.

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[-] TrumpLyftAlles | 3 points | Jul 09 2020 00:59:59

This is the TrialSiteNews take on this study.

University of Baghdad Pilot Clinical Trial: Ivermectin plus Hydroxychloroquine & Azithromycin Superior to No Ivermectin

A couple weeks ago, Professor Gorial communicate with TrialSite News that he was trying to publish his results. In the meantime, they have been posted to the medRxiv preprint server, so they are still not “peer reviewed.”

This is after about a month of ClinicalTrials.gov sending the article back twice.

Wow, this is quite the cynical take!

Unfortunately, as throughout history, at times certain influential or powerful groups, for whatever reason, don’t necessarily desire the best outcome for all. Purported scientists are employed to quickly discount, dissuade and disqualify some emerging and meaningful trend that could lead to a, guess what, surprising outcome. Those defenders of the status quo evidence absolutely no intellectual curiosity as applied to anything that doesn’t fit within the limited confines of their own narrow assumptions.

Links to a lot of the ivermectin findings reported on TSN!

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[-] TrumpLyftAlles | 1 points | Jul 08 2020 22:26:09

Interesting! An automated review of the preprint.

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[-] TrumpLyftAlles | 1 points | Aug 14 2020 17:16:18

There is a whiteboard discussion of this research on youtube.

TLATODO: Watch this

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