The race to find vaccines for COVID-19 has dominated the headlines, but there's been less news about how to keep people with COVID out of the hospital. Tonight, we're going to tell you a story about one possible treatment. It's called fluvoxamine. The generic drug was developed 40 years ago as an antidepressant and has been primarily used to treat obsessive-compulsive disorder. Now, a small but ingenious clinical trial and a series of coincidences have led scientists to look closely at fluvoxamine as a possible tool to keep newly diagnosed COVID-19 patients from becoming severely ill. So how did a pill that costs 60 cents become a dark horse to treat COVID? We went to a place that knows all about long shots to find out.
Golden Gate Fields is in Berkeley, California. The stands have been empty since COVID hit last year, but the races go on. There are 1,200 thoroughbreds here – trained and cared for by more than 500 people. Last November, COVID went on a rampage in the barn area where many workers live.
Dr. David Seftel: We had four cases that were initially reported and because we have a community living back there, we decided to test everybody. And that's when we saw the first round of testing reveal 200 positive individuals.
Sharyn Alfonsi: Wow. What was your reaction when you heard 200 positive cases right here?
Dr. David Seftel: Shock and dismay.
Dr. David Seftel has been the physician for employees and their families at Golden Gate Fields for 20 years.
He is originally from South Africa and is Harvard-educated.
Sharyn Alfonsi: Who was sick? Was it the jockeys, was it the guys who work in the stable, their families?
Dr. David Seftel: It was really across the entire spectrum. And what's interesting about our community is that it really is a mirror image of the community that is most affected by COVID, predominantly Latino community, incredibly hardworking. They don't have the luxury of working from home or working on Zoom. They have to be out there every single day.
But there are few early treatment options for COVID. The handful of drugs that have been approved are for high risk patients and must be delivered intravenously, often in a hospital.
Dr. David Seftel: When I looked at this community, I said I know the numbers, I know the stats. There are gonna be deaths and there's gonna be disability unless I take action.
Sharyn Alfonsi: Is that what you were thinking as the numbers kind of rolled in?
Dr. David Seftel: This was a disaster in the making.
Dr. Seftel felt his only choice to keep his patients from getting sicker was to act on a tip he got just hours before. The doctor offered them the antidepressant fluvoxamine. To understand why, you have to go back to the starting gate of our story.
Eight months earlier in March, Dr. Angela Reiersen, a child psychiatrist at Washington University in St. Louis, was home sick with COVID symptoms. And thinking about old medical studies she'd read.
Sharyn Alfonsi: Most people when they're home sick with COVID, they say, "Look, I just wanna sit on the couch, and ride this out."
Dr. Angela Reiersen: Well, I didn't wanna just sit there and be sick. I was really kind of driven to try to find answers.
Dr. Reiersen remembered a study published a year earlier by these researchers at the University of Virginia on mice. They found fluvoxamine stopped sepsis. Sepsis is a runaway immune response in which inflammation gets out of control, damages organs and can be deadly. It's believed a similar phenomenon occurs in COVID patients.
Dr. Angela Reiersen: And I thought, well, I wonder if we could use fluvoxamine to treat COVID and prevent that clinical deterioration?
Sharyn Alfonsi: You thought, this is something that might be able to stop inflammation from going into overdrive?
Dr. Angela Reiersen: Right. Either stop the inflammation from going into overdrive or shut it down once it had started to prevent our own bodies from destroying ourselves basically. So, then I emailed Eric Lenze, and just kind of explained the whole rationale behind it in an email.
Dr. Eric Lenze is also a psychiatrist at Washington University. He specializes in finding new uses for drugs already approved by the Food and Drug Administration.
Sharyn Alfonsi: Did you have some skepticism at first?
Dr. Eric Lenze: Amazingly, I did not. Angela presented a very compelling and innovative case for this drug. And it turns out that there's a lot of properties of-- psychiatric drugs like… safety and ease of use… and the fact that they can get into the body quickly that makes 'em actually ideal for repurposing.
The doctors got $20,000 from Washington University last April to launch a small randomized clinical trial on fluvoxamine. But getting patients to try an antidepressant for COVID was hard.
Sharyn Alfonsi: How'd you sell it?
Dr. Eric Lenze: Yeah, and that was a real steep learning curve for us as well that we're doing with this antidepressant drug that we usually use for obsessive-compulsive disorder. Imagine you're a patient at home, sick with COVID and you get a phone call like that.
Patients who agreed didn't have to leave their homes. Researchers would drop off a paper bag containing fluvoxamine pills to half of the COVID patients. The other half would get a placebo, with instructions to take the pills for 15 days.
Dr. Eric Lenze: Our team was acting like-- couriers, or, if you will, delivery men, dropping it off at their house. And then we would work with them through the phone and the internet. By May we were kind of running on fumes, as far as-- funding went. Fortunately it was at that point that I-- read in the New York Times, of all places, about the COVID Early Treatment Fund.
Steve Kirsch is the founder of the group Lenze read about. Kirsch is a Silicon Valley entrepreneur who made a fortune developing the optical computer mouse. He put up a million dollars of his own money and then assembled a panel of scientists to decide which covid research he should fund.
Sharyn Alfonsi: Tell me about the first conversation you had with Dr. Lenze.
Steve Kirsch: You know, we were like, oh, we-- we got a grant application. This is thrilling to us. And it's for $67,000… and so it's a very modest amount, so we ran it through the scientific advisory board and they said, you know, this is novel.
Steve Kirsch cut the check, which allowed Dr. Lenze to finish recruiting the 152 patients he needed for his trial. It was completed in August.
Dr. Eric Lenze: So the results were really pretty incredible. Out of the 80 people who received fluvoxamine, none, zero of them deteriorated versus-- 8% of the people-- who got placebo.
You heard that right. The patients on fluvoxamine did not deteriorate to the point of severe lung damage.
Steve Kirsch: And he goes over the results and I'm like, holy moly.
Sharyn Alfonsi: You probably wanted to scream it from the rooftops at that point.
Steve Kirsch: Oh, absolutely--
Sharyn Alfonsi: And how did Dr. Lenze and his colleagues react?
Steve Kirsch: He said, "Well, look, we have to get this published or nobody's gonna believe it. We want to submit it to JAMA – the Journal of the American Medical Association because that is the top journal for this once you put it in JAMA, and they publish it, then everybody will believe it."
It was published in November. But while the editors offered high praise for the study's methodology – they said the results "should not be used as the basis for current treatment decisions." That's because the editors wanted confirmation in a larger trial. Not the speed Steve Kirsch is used to in Silicon Valley.
Sharyn Alfonsi: I imagine you think the next morning, you're gonna be front-page news on the New York Times--
Steve Kirsch: And everybody starts taking it and all the doctors start-- you know, people start demanding it.
Sharyn Alfonsi: But that did not happen.
Steve Kirsch: No--
Sharyn Alfonsi: You ended up on a webinar.
Steve Kirsch: Yes. I ended up on a webinar.
This is the webinar that night about COVID.
It was for Harvard Business School alumni and the host was David Seftel. The race track doctor. It was just hours after Dr. Seftel hosted the group that he learned about the massive outbreak at Golden Gate Fields.
Sharyn Alfonsi: Had he heard about fluvoxamine at that point?
Steve Kirsch: No.
Sharyn Alfonsi: So he hears it from you on the webinar?
Steve Kirsch: He hears about it from me on his webinar.
Sharyn Alfonsi: Were you skeptical at all about what he was saying?
Dr. David Seftel: Absolutely. And I'm a born skeptic. Right after the webinar, I took a deep dive into the science. And then I looked at Eric Lenze's paper. A paper that was selected out of 10,000 other papers by the JAMA for publication because its methodology was strong. This is something that I felt comfortable with taking to patients.
So Dr. Seftel decided to offer a 15-day prescription for fluvoxamine to the track workers with COVID.
Sharyn Alfonsi: Did you feel like you were placing a bet on these patients at all?
Dr. David Seftel: No, because I weighed the risk and reward. And in this particular circumstances, strong biochemistry, great initial clinical results, minimal downside. I felt I had to act.
Dr. Seftel's decision to use a prescription drug off-label is an accepted medical practice – with patient consent. The most common side effect of fluvoxamine is slight nausea.
Sharyn Alfonsi: How many of them ended up taking the fluvoxamine and what was the outcome?
Dr. David Seftel: Sixty-Five patients elected to take fluvoxamine. Forty-eight declined. 12.5% of all those who refused fluvoxamine ended up hospitalized and one died. In the group that did take fluvoxamine, none of them were hospitalized.
Once again - none of the covid patients taking fluvoxamine deteriorated.
Sharyn Alfonsi: Could it have been a fluke?
Dr. David Seftel: I don't believe so. You cannot influence a virus that is as wily and as wicked as COVID with a fluke.
But to be trusted by the wider medical community, fluvoxamine needed a larger trial. So Steve Kirsch's fund put a half million dollars behind a new trial led by Dr. Eric Lenze. Paper bag deliveries have been replaced by FedEx boxes that the team plans to ship to more than a thousand COVID patients around the country and Canada.
Dr. Eric Lenze: I have to be a scientist about this. We've tested it in one study. But-- in my view, it needs to be confirmed in a larger study.
Sharyn Alfonsi: Is it reasonable to think that this drug could be an answer?
Dr. Francis Collins: Fluvoxamine could certainly be something you wanna put in the tool chest. 'Cause it looks as if it has the promise to reduce the likelihood of severe illness.
Dr. Francis Collins is the director of the National Institutes of Health. As part of the pandemic response, Collins oversees the federal effort to identify drugs to repurpose for COVID treatment. It's a priority because of concerns that new COVID variants could make vaccines less effective.
Dr. Francis Collins: Dr. Lenze is a great example of a physician scientist who probably never planned to work on an infectious disease. And yet approaches it with appropriate skepticism about anything that isn't absolutely certain because you don't want to make that recommendation unless you know for sure.
Sharyn Alfonsi: And how closely will you be watching-- what he reports?
Dr. Francis Collins: The whole scientific community is watching his study and trying to see whether there's a way we can help in our own trials. We're strongly considering adding an arm to one of those trials to test fluvoxamine. To further add to the data that could be generated.
There's been great caution about recommending repurposed drugs for COVID after the malaria drug hydroxychloroquine was promoted as a potential "game-changer" by former President Trump – before it was tested in a large clinical trial on COVID patients.
Sharyn Alfonsi: What is the bar for a drug like fluvoxamine to be widely used?
Dr. Francis Collins: Well, it's the FDA who will have the job of figuring out whether to give an approval-- for this use of that drug. And it will be about benefit and risk. And the benefit is maybe even a reduction of 20% of the chances that you're gonna end up in the hospital, that's probably a good thing. That should be added to the mix.
The first results from the national trial could come next month, a little more than a year after Dr. Angela Reiersen sent Dr. Eric Lenze that email about fluvoxamine.
Sharyn Alfonsi: Your colleague had to read the study. Silicon Valley guy had to step in. Then there's some people at a race track that are gonna try it out. It seems unbelievable.
Dr. Eric Lenze: If you had told me what the odds were at the start of this, I might have reconsidered doing this.
Sharyn Alfonsi: It was a long shot.
Dr. Eric Lenze: For sure.
Produced by Guy Campanile. Associate producer, Lucy Hatcher. Broadcast associate, Elizabeth Germino. Edited by Peter M. Berman.
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