Better ivermectin data is finally on its way

Edward Mills came at last month’s meeting with very good data. An expert in clinical trials at McMaster University, Mills presented new results from a trial that examines how well a half-dozen different drugs treat Covid-19 – not for people so sick they’re in the emergency room or in the hospital. hospital, but in people whose symptoms have not yet worsened. Sick people at home, in other words.

At his online conference, hosted by the National Institutes of Health, Mills’ slides told the story: A relatively safe, familiar, and inexpensive drug reduced the relative risk of worsening mild Covid by nearly 30% . The drug is fluvoxamine, a selective serotonin reuptake inhibitor, an antidepressant. (It’s also an anti-inflammatory, and inflammation and an overreaction of the immune system are hallmarks of a severe Covid infection, which may be why it seems to help.) Get a group of people with Covid and randomly divide them into two groups; 739 receive fluvoxamine and 733 receive placebo. Only 77 of those taking fluvoxamine end up in hospital; 109 of the placebo group do so. That’s exciting.

“Is this the first time that these results have been presented in a public forum?” Asked moderator Adrian Hernandez, director of the Duke Clinical Research Institute.

“Yeah,” Mills replied. “You hear it for the first time.

“Well, quite simply, wow,” Hernandez said. If the data is confirmed, it will only be the second drug reused that will work for outpatient Covid-19. (The other is a steroid called budesonide; other drugs you may have heard of, such as remdesivir or dexamethasone, are for critically ill and hospitalized people.) The team’s results did not appear. yet been peer-reviewed or officially published, but the The Together essay, on which Mills is a co-principal investigator, is well-designed and well-respected. Now, to be clear, fluvoxamine is still far from being part of the standard of care for people with Covid-19. Once the results of the Together trial are released, guideline-setting organizations like the U.S. Food and Drug Administration and the World Health Organization will need to take a look. But the data from the Together trial, if they hold up, looks positive for the SSRI.

But wait! There is more! In the same presentation, the same trial which showed that this antidepressant could alleviate the symptoms of Covid-19 too has shown the antiparasitic drug Ivermectin – you’ve heard of it, haven’t you? – does not help at all. In the Together trial, this drug, commonly used against things like river blindness and intestinal roundworms, did not prevent people with Covid from being discharged from the hospital better than a placebo. Out of 677 people with Covid who received 400 micrograms per kilogram of weight per day for three days, 86 ended up in the emergency room or hospital; of the 678 people who received a placebo, 95 went. That’s not a significant difference, and Mills’ team pulled it out of the study. (Vaccination, I should add, remains the most effective, safest, cheapest, and easiest way to avoid getting sick.)

Ivermectin had some promising early results against the virus in petri dishes and in smaller, observational studies, but it still has failed a trial. Of two apparent large-scale confirmations of its effects, one (a preprint by Egyptian researchers) was retracted due to concerns about plagiarism and fake data. Scientists and reporters at BuzzFeed found irregularities in another’s data. A separate and positive review of all ivermectin data was rejected from a provisional acceptance review for concerns about research integrity and conflicts of interest, while a strict meta-analysis of all randomized controlled trials of ivermectin against Covid have found no positive effects for the drug. The FDA says people shouldn’t be taking it. The American Medical Association and two pharmacy associations have issued a statement recommending that none of their members prescribe ivermectin for Covid-19 outside of a clinical trial. (Oh, and an Arkansas doctor gave the drug to inmates without knowing it and without consent, which isn’t usually the side of the story you want to be on.)