Crystal Cox/Business Insider
- The malaria drugs chloroquine and hydroxychloroquine have rapidly become top potential coronavirus treatments.
- But they lack any high-quality clinical evidence that shows they are effective against COVID-19.
- Dr. David Boulware, a University of Minnesota infectious disease professor, is running two experiments to test hydroxychloroquine in large controlled trials to determine the drug's effectiveness. Both are now open for enrollment.
- One study is assessing whether taking hydroxychloroquine can prevent infections in people who have recently been exposed to the virus. The other trial is seeing if taking the drug can reduce the hospitalization rate for COVID-19 patients who just started to show symptoms.
- People can now apply to enroll in both studies at trialcovid.com. The researchers are hoping to have clinical results from both studies in about a month.
- Visit Business Insider's homepage for more stories.
An old, generic malaria drug has rapidly become a leading potential coronavirus treatment, as President Donald Trump has repeatedly touted its potential against the virus and the US government has built up a massive stockpile of the medication.
On Sunday, the US Food and Drug Administration granted an emergency authorization - the first for any COVID-19 treatment - allowing doctors to use chloroquine or hydroxychloroquine in hospitalized COVID-19 patients who cannot enroll in clinical trials.
While Trump has talked of chloroquine as a game changer, there remains little clinical evidence showing the pills work against the virus.
'We should know if it works'
"There's some suggestion that maybe it works, but there isn't any good data," Dr. David Boulware, an infectious disease professor at the University of Minnesota, told Business Insider. "If we're going to give this medicine to tens of thousands, or hundreds of thousands, or millions of people, we should know if it works."
Boulware has made it his goal to find out, launching two large clinical trials that will evaluate hydroxychloroquine in two different groups of people. The trials will answer two big questions: can hydroxychloroquine prevent infections, and can it reduce hospitalization for those who already are infected?
He started enrolling patients about two weeks ago, well before the malaria drug gained so much public attention.
One trial is testing people who have been exposed to a known case in the past few days, such as frontline healthcare workers or family members living with a COVID-19 patient. Boulware is looking to see if this group of people can lower their chances of developing an infection by taking hydroxychloroquine.
The second study is recruiting COVID-19 patients who have just started developing symptoms, with the cutoff being four days of symptoms to enroll in the study. This group will be tested to see if hydroxychloroquine can reduce the need for hospitalization by treating this patient group early on in the disease's course.
The researchers will mail the pills or a placebo to your home
"My goal is to figure out does it work," Boulware said. "I don't know the answer, but we'll know soon."
To arrive at an answer and get clinical results, the researcher first needs to fully enroll both trials. As of March 30, 537 people have enrolled in the prevention study and 74 have enrolled in the study on people with early symptoms. Boulware is aiming to enroll about 1,500 people in each one.
For those interested in enrolling, the study is virtual, meaning there are no site visits. People either email covid19@umn.edu for info, or can go to trialcovid.com to apply. Applications are reviewed automatically, and those that qualify are immediately notified via email (Boulware said to make sure to check your spam folder.) Researchers than ship out the medicine overnight.
Enrolled participants are randomly assigned either hydroxychloroquine or placebo tablets mimicking the drug. They don't know which one they are on, and the researchers are also blinded to that until data analysis to reduce the potential for biased results.
People who get hydroxychloroquine will receive a 5-day treatment, ingesting 800 milligrams as a starter dose along with 600 milligrams each day for the first five days.
The studies will help determine if hydroxychloroquine works
All participants then fill out four of five follow-up surveys over the next two weeks, Boulware said. These are simple questionnaires that should take a couple minutes, asking questions like if they have been hospitalized, feel sick, or notice any side effects.
These studies are important because they will determine if hydroxychloroquine is an effective treatment at either preventing infections or preventing hospitalizations, Boulware said.
"The vast majority of people are not hospitalized," he said. "Besides social distancing and quarantine, if we can break that chain of infection by identifying somebody and then prophylax everyone around them that's been in contact with them to prevent infection, you can stamp out stuff much quicker."
The researcher is hoping to reach full enrollment in about two weeks and be able to have results from the study in about one month from now.
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