MINNEAPOLIS — More than a week ago, David Boulware had a eureka moment. The professor of medicine at the University of Minnesota thought to himself — what if a common, inexpensive, “old school” anti-malaria pill could help prevent the spread of the novel coronavirus?
Virtually overnight, Boulware has assembled a team of 10 U of M medical scientists, statisticians and pharmacologists to test out his theory, which involves feeding a preventative medication that’s been around since 1955 to volunteers for five days. His team will monitor which ones contract the COVID-19 virus and which ones don’t.
“We started yesterday,” said Boulware on Wednesday, March 18. “Our hypothesis is we’re going to reduce the number who get sick by 50 percent, and hopefully more than that.”
The U of M Ethics Board quickly signed off on his national clinical trial, and the U.S. Food and Drug Administration has sped up its own review. Boulware’s experiment enrolled his first 25 volunteers on Tuesday, about nine days after he organized his team.
This doesn’t happen very often. Experiments testing active drugs on live patients usually take six months to a year just to get up and running.
For Boulware’s team, there’s only one big hurdle remaining: finding up to 1,500 volunteers who have definitely been exposed to the virus. He’s not looking for people with a general concern.
“The inclusion is someone with a known exposure to someone they live with, or a health care worker exposed to a patient,” Boulware said. “Those are the people with the highest risk of transmission. If it works in this highest risk group, it will work in lower risk groups, as well.”
The U of M issued a widespread call Tuesday for volunteers willing to enroll in the trial, which involves feeding half the volunteers the drug and the other half a vitamin placebo. Both groups will be monitored remotely for two weeks to determine who gets a bit ill, who gets really ill and who doesn’t get sick at all.
Boulware, whose major focus is usually HIV-related anti-fungal meningitis trials in Africa, said this test involves hydroxychloroquine, an FDA-approved medicine for the prevention and treatment of malaria. The pills, available since the 1950s, are sold under the brand name Plaquenil(R).
A five-day supply costs about $12.
He said the drug clearly works against what’s known in the lab as the SAS-Covi2 virus, but in a petri dish. Despite some “hints and rumors” leaking out of China, said Boulware, it has not been officially tested on humans.
“The data suggests it works in the lab — in a petri dish, in a subculture — but the hints and rumors that it may be effective for treatment, that hasn’t been confirmed,” he said.
Could a cure for coronavirus around the corner? Boulware cautions that preventing infection in a healthy person who lives with or has been in contact with an infected patient may be a far cry from treating someone who already has advanced symptoms.
“Treating people with severe disease may be different than prevention,” Boulware said. “It’s much easier to treat someone early on. After they get sick, and they have severe symptoms, it’s harder, especially for viral infections, to alter that course.”
Nevertheless, said Boulware, “I think I’m optimistic. I wouldn’t be doing this if I wasn’t optimistic.”
If you think you may be eligible to participate in the clinical trial, email firstname.lastname@example.org for further instructions.
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