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Edward Mills came until the meeting last month with very good data. An expert in clinical trials at McMaster University, Mills presented new results from a study that looked at how well half a dozen different drugs treat Covid-19-not for people who are so sick that they are in the emergency department or hospital, but in people whose symptoms have not yet worsened so much. In other words, sick people at home.
In an online interview with 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 percent. The drug is fluvoxamine, a selective serotonin reuptake inhibitor – an antidepressant. (It’s also anti-inflammatory, and inflammation and an overreacting immune system are hallmarks of a serious Covid infection, so maybe that’s why it seems to help). Take a bunch of people with Covid and randomize them into two groups; 739 received fluvoxamine and 733 received placebo. Only 77 of the fluvoxamine recipients were hospitalized; 109 from the placebo group. This is exciting.
“Is this the first time these results have been presented at a public forum?” Asked moderator Adrian Hernandez, director of the Duke Institute for Clinical Research.
“Yes,” Mills said. “It’s the first time you’ve heard it.”
“Well, just wow,” Hernandez said. If the data disappears, it will be only the second diverted drug to work for the Covid-19 outpatient. (The other is a steroid called budesonide; other drugs you may have heard of, such as remdezivir or dexamethasone, are for people who are seriously ill and hospitalized.) The team’s results have not yet been reviewed or officially published, but the Joint Study , of which Mills is the chief investigator, is well designed and respected. Now, to be clear, fluvoxamine is still far from becoming part of the standard of care for people with Covid-19. Once the results of the Together study are published, guidelines organizations such as the US Food and Drug Administration and the World Health Organization will need to consider. But the data from the Together test, if retained, appear positive for SSRIs.
But wait! There is more! In the same presentation, the same study that showed this antidepressant may reduce the symptoms of Covid-19. too showed that the antiparasitic drug ivermectin – you’ve heard of it, right? – It doesn’t help at all. In the Together trial, this drug, often used for things like river blindness and intestinal roundworms, didn’t stop anyone with Covid from getting out of the hospital better than a placebo. Of the 677 people with Covid who received 400 micrograms per kilogram of body weight per day for three days, 86 ended up in the emergency department or hospital; of the 678 people who received a placebo, 95 went. This is not a significant difference and Mills’ team dropped it from the study. (I must add that vaccination is still the most effective, safest, cheapest, and easiest way to avoid the disease.)
Ivermectin has some promising early results against the virus in petri dishes and in smaller and observational studies, but has not yet been successfully tested. Of the two obvious large-scale confirmations of its effects, one (a preprint by researchers in Egypt) was withdrawn due to concerns about plagiarism and false data. Scientists and journalists from BuzzFeed have found irregularities in the data from another. A separate, positive review of all ivermectin data was rejected by the journal after provisional admission due to concerns about research integrity and conflict of interest, while a rigorous meta-analysis of everything randomized, controlled trials of ivermectin against Covid found no positive effect on the drug. The FDA says people should not accept it. The American Medical Association and two pharmaceutical associations have issued a statement recommending that none of their members prescribe ivermectin for Covid-19 outside of a clinical trial. (Oh, and a doctor in Arkansas gave the medicine to unknown, dissenting prisoners, which is usually not the side of the story you want to be on.)
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