According to this article, a Japanese pharmaceutical company has found that Ivermectin has an “anti-viral effect” against COVID-19 in non-clinical research. Originally, the article said Ivermectin was “effective” against COVID, but this was amended to “anti-viral effect”. I was just wondering if any medically knowledgeable dopers could help me with a couple of questions.
What’s the difference between Ivermectin being effective and Ivermectin having an anti-viral effect? From my layman’s perspective those sound like they mean the same thing.
What does non-clinical research mean in this context? Again, as a layman, I don’t get how the efficacy of any drug could be established outside of a clinical setting.
That article was pretty sparse on details, so it’s really hard to say. But, honestly, this really sounds like old news.
Ivermectin has been shown in the past to have anti-viral effects in vitro - that is, in cell cultures in a lab. What has never been demonstrated is clinical effectiveness. That is, if you give ivermectin to actual human beings, that it has any actual effect on documented clinical outcomes - severity or duration of symptoms, hospitalization rates, mortality rates, etc. Or, for that matter, any direct evidence that it has any impact on actual viral loads or viral activity in actual human beings.
A lot of substances show “anti-viral effects” in vitro. Very few substances show any significant clinical effectiveness as anti-viral treatments. It should probably also be noted that many substances that do show anti-viral effects in vitro are used in such high concentrations that they would themselves be toxic if applied to actual human beings. As I understand it, this is true with previous in vitro studies of ivermectin.
Again, this article is pretty sparse on details, so it’s hard to say for sure. But it really sounds to me like these researchers just did some more in vitro studies and found anti-viral activity in cell cultures in a lab. Which is very far from demonstrating clinical effectiveness - that is, that it would actually be useful in treating actual human beings in the real world. And all of that is old news.
This. Rubbing alcohol melts down virus particles very nicely in a test tube at high enough concentrations. You could describe it as having an anti-viral effect. This does not mean that rubbing alcohol would be an effective treatment for a person with a COVID infection.
The clinic is where you conduct clinical trials that test treatments on actual human beings. Before you can do that, you start in a lab with cell/tissue samples and animal models (mice, non-human primates, etc.) to get a sense of whether it’s likely to be effective and safe for humans. If a pharmaceutical company is about to start a full-scale clinical trial on human test subjects, then they are probably are already pretty confident about the results.
One thing did occur to me. This is pure speculation, but it would explain the initial confusion by Reuters over whether there was a Phase III human clinical trial.
It’s possible that the Japanese researchers were looking at viral loads and/or viral activity in cultures collected from human beings, and that they found statistically significant differences between people treated with ivermectin and people who weren’t. That would be an interesting result, but not necessarily an important one.
To demonstrate that ivermectin is an effective treatment for COVID, the only important thing is if it actually, y’know, treats COVID - the clinical outcomes. Are people treated with ivermectin hospitalized at lower rates? Are they put on ventilators at lower rates? Is their average hospital stay shorter? Their average time on a ventilator? Are their mortality rates lower? Do they report less severe symptoms? Shorter symptom durations? Etc.
Now if - and that’s a HUGE “if” - the study in question actually did show some sort of anti-viral effect in actual humans “in the wild”, that might be an interesting indication that ivermectin might be useful in making people with COVID less infectious. If that’s the case, and if that’s borne out by other studies, that might mean that it could actually be useful to give people infected with COVID a course of ivermectin as an infection control measure. But there are still a lot of “ifs” and “mights” there.
In a citywide ivermectin program with prophylactic, optional ivermectin use for COVID-19, ivermectin was associated with significantly reduced COVID-19 infection, hospitalization, and death rates from COVID-19.”
I recall a study (might have been in Peru but I’m not sure) where an entire geographical area (state?) was given ivermectin and the surrounding area was not. The results clearly showed a large benefit for ivermectin. When surrounding areas were treated the incidence of severe infection dropped dramatically and immediately.
There was another large study (also in South America, I think) where the results were disputed because it was not a double-blind test … because the scientists couldn’t find enough people in the area who were not taking ivermectin; a huge percentage of the people were already taking it as a prophylactic.
IMHO, most of the ivermectin bashing on social media and the mainstream media is based on politics, not science.
Bleach has an antiviral effect - it produces an environment that is harmful to viruses and stops them from replicating. Bleach is not an effective medicine for Covid-19.
Ivermectin is like the very safest form of bleach to have floating around your blood. For most people, it is relatively safe (when you use the form formulated for humans and take it in appropriate doses, under the watch of a doctor). But for the sort of person likely to be killed by Covid-19, Ivermectin is sufficiently harmful to the body that its antiviral properties are replaced by its poisonous qualities and you end up back where you started or even worse.
Also importantly, Ivermectin does not have any prophylactic abilities. Meaning: Taking it when you’re not sick just means that you’re ever so slightly poisoning yourself, for literally no reason. It will not leave you protected in any way against a virus. Rather, it will leave you less protected because your body will remove the poison more quickly than it will fix the damage done to the body.
The most important thing is that the are antivirals like Remdesivir and Paxlovid that are available, safe, approved, and far more effective than Ivermectin. Anyone searching for a non-vaccine solution has every chance to use an antiviral, just not the one that’s so far not shown to be useful in any way.
But, similar to Ivermectin, these antivirals do not offer any protection against getting sick. They are only useful when you have been diagnosed as being ill with a viral infection. At that point, the doctor will give them to you and try to save your life.
Before that point, though, it’s better to just get vaccinated.
Your study isn’t peer reviewed, it’s an observational study, not a clinical study, and just because idiots in the US take ivermectin as a prophylactic doesn’t stop idiots elsewhere from taking it. If anything, people in small villages in Peru might have a better excuse to try anything because they probably don’t have access to the free, safe, and effective COVID vaccine like we do here in the First World.
If ivermectin has any effect at all on people with COVID, it’s probably because those people were already dealing with a parasite infection. In any case, there is zero chance that it’s as effective as the vaccine for preventing sickness and you should stop implying that it is, because that kind of COVID misinformation is killing people.
“Dr. Nikolas Wada, an epidemiologist with the Novel Coronavirus Research Compendium at Johns Hopkins, raised concerns about the study’s uncertainty over who was “truly taking ivermectin and vice versa” and poor control for factors that may predispose someone to catch COVID-19, among other issues.”
“My primary takeaway,” Wada said, “is that this paper adds nearly nothing to the knowledge base regarding ivermectin and COVID-19, and certainly does not prove its effectiveness as a prophylaxis.”
Two of the authors on that Brazilian study are members of the Front Line Covid-19 Critical Care Alliance, a fringe group promoting bogus Covid-19 therapies and opposition to vaccines.
In addition to a stunning lack of evidence for ivermectin’s effectiveness against SARS-CoV-2, the levels of the drug at which it’s been shown to have some antiviral effect in cell culture would require dosage levels far beyond what’s been shown to be safe in humans.
In contrast to Turble’s take, my opinion is that social media enthusiasm for ivermectin has been heavily influenced by politics, resentment of health experts and antivaccine ideology. The comparatively few MDs and scientists who promote it are driven by similar motivations, plus a desire for publicity and the ability to make money off credulous supporters.
Here’s something I’ve always kind of wondered about but never looked into:
The company making money off ivermectin isn’t Merck—the giant drugmaker accounts for less than 1% of the ivermectin prescribed in the U.S., according to data from IQVIA Holdings Inc. Private-equity-owned Edenbridge Pharmaceuticals LLC, which manufactures a generic version of the pill, makes the rest. A product that brought in just shy of $800,000 in monthly sales on average in 2019 raked in revenue of $42 million in August alone, the IQVIA data shows.
Are you aware – both – of the fact that this study was not randomized and of the possible, probable, likely impacts of that ?
In other words, the study allowed the ‘participants’ to pick the group they wanted to be in – Ivermectin or no Ivermectin.
The study makes my point at least as well as I could:
Being a prospective observational study that allowed subjects to self-select between treatment vs. non-treatment instead of relying on randomization, important confounders may have been differentially present, which could otherwise explain the differences observed.
This alone barely makes its results interesting, much less worthy of further study. It pretty much invalidates their results.
Double blind, randomized, and placebo-controlled with statistically significant sample sizes. That’s the coin of the realm.
Political swipes aren’t appropriate in fact-based threads in the Quarantine Zone. This one didn’t have the “Factual” tag (I’m about to fix that) but the OP is clearly a fact-based question. Please avoid this type of post.
Ivermectin is cheap, widely available, not terribly toxic, and showed some promising results against COVID. So it’s perfectly reasonable that a lot of studies have been done, along with some hail-mary treatment. However, if you are asking “should I be taking ivermectin if I am diagnosed with covid”, two articles you should be aware are are:
TL;DR a lot of the studies that have been wrapped up into metastudies turn out to be outright fraud. Some of the early authors of metastudies advocating for ivermectin have repudiated their own work after discovering this.
TL;DR if you segregate the better-quality studies by those conducted in places where strongyloides parasitic worms are common, and those where they aren’t, all the best results for ivermectin take place where people are likely to be coinfected with the worms. This makes a lot of intuitive sense, as the treatment for serious covid (steroids) dampens your immune reaction to the worms, and they can then cause more serious problems. Ivermectin can prevent these. (steroids may even increase the fertility of the worms within your body.)
So, if you live in a place where your odds of being infected with parasitic worms is low, it’s unlikely that ivermectin will help you survive covid.
The propensity score matching in the Brazil study is a statistical analysis that is used when randomizing and blinding and tight control of subjects isn’t feasible. It is kind of like a poor man’s randomized study but doesn’t ever replace a controlled clinical trial.
The idea is that the researchers collected demographic data and whatever data was at hand from their registry, and offered ivermectin. That variable became ‘did you take ivermectin, yes/no’ and linked the patients with hospitalizations and deaths. They say that they offered a specific limited dose but we all know how that worked out with the pro-ivermectin advocates.
The endpoint was to compare hospitalization and mortality in the Yes ivermectin group with No ivermectin group by matching on age, gender, comorbidities, smoking and so on. After you balance and adjust for that stuff, the argument of the propensity score matching is whether what is left over is the ivermectin effect. However, if you miss an important confounding variable, you haven’t really learned anything.
This is a problem with registry studies - you only can analyze what the registry has collected.
It is important to consider that ivermectin participation was voluntary, like @DavidNRockies said, and people who elected to take ivermectin in 2020 may also have taken dozens of other of things as prophylaxis. Or they may have had a lot of free time and didn’t go out socially or go to their jobs. The study team didn’t measure education level or SES and so this could be a confounding variable for ivermectin.
Also with any gigantic study, it’s likely to have statistically significant p-values. The question is whether the results are clinically important and reproducible.
The propensity score matching RR for mortality was ~0.30 (0.8% vs 2.6% mortality). Is that 0.8% vs 2.6% difference impressive? Maybe? Maybe not.
It’s an intriguing result but it has limitations and is far away from any reproducible or actionable evidence to the ivermectin question (my opinion).
