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University of Hawaii opens first COVID-19 clinical trials to treat patients

Hawaii researchers are scrambling to find treatments for coronavirus infections that are slowly creeping up as the state begins to reopen for business and residents emerge from isolation.

Researchers at the University of Hawaii John A. Burns School of Medicine are seeking 40 adults with active COVID-19 to participate in the state’s first outpatient clinical trial to find an effective treatment for the virus that has sickened more than 2 million and killed more than 100,000 in the United States.

Half of the patients, who must be symptomatic, will be placed on a placebo sugar pill and half on the drug telmisartan for 21 days. The trial will include blood tests and at least four throat swabs to detect active virus. The participants must monitor their temperature and blood pressure during the trial, which excludes people who are seriously ill with other underlying conditions.

If successful, researchers will pursue a larger study of more participants. The drug, which is approved by the U.S. Food and Drug Administration to lower blood pressure, could be used immediately to treat coronavirus infections.

“If we can get something that will treat COVID-19, that’s going to be a game-changer … in how quickly we can open up our state,” said Cris Milne, research nurse at the UH Hawaii Center for AIDS, adding that the goal is to lesson the symptoms of cardiovascular and respiratory complications that are causing fatal outcomes. “We want everybody who’s already tested positive just to have mild symptoms. That way it’s not going to be as devastating. I believe personally the only way we’re going to get our economy back is to be able to treat people once they get a positive COVID-19 test.”

Dr. Cecilia Shikuma, an infectious disease specialist and director of the Hawaii Center for AIDS, said there are many other national studies on similar medications.

“But what I’m struck by is there are already studies — the largest coming out of China — that say people who are on these medications tend to do better if they do get infected by COVID-19,” she said. “It’s using a drug that’s already FDA-approved, so it’s been out in the community for a while … so we know what its safety profile is. Obviously, everyone’s really worried about people getting really ill with complications of COVID-19, so whatever anybody can think of that might work, I think, would be really welcome.”

The scientists have applied for a $125,000 grant from the National Institutes of Health to fund the pilot study, which is free for participants.

In some cases, COVID-19 causes extreme heart and lung damage by impairing the hormone system that regulates blood pressure. Telmisartan could block the hormones, potentially limiting the heart and lung damage caused by the virus. The group is collaborating with the University of Southern California to measure various components of the hormone system, and to see whether certain inflammatory markers decrease. To participate in the outpatient trial call 692-1335 or email cmilne@hawaii.edu.

Meanwhile, researchers at The Queen’s Medical Center are conducting three separate trials on hospitalized coronavirus patients to see whether certain drugs help speed the recovery process.

The studies include hydroxycloroquine, FDA-approved for lupus; tocilizumab, used to treat arthritis; and convalescent plasma, which injects antibodies from recovered patients into those who have not had time to develop their own internal defense systems.

The researchers plan to contribute the data to larger research sites including Johns Hopkins University, along with other scientists, to get a bigger picture of which drugs are effective at treating the disease.

“Think of our studies as being a Lego block. We’re contributing our data with other people. We put our Lego blocks together to make a whole and understand whether that medication works for COVID-19,” said Dr. Todd Seto, director of academic affairs and research at The Queen’s Health Systems.

Hawaii must still conduct other research on how the coronavirus affects society as the state reopens, he added.

“We need that kind of research. We can’t depend on mainland researchers to tell us how to reopen our society.”

The state’s tally of coronavirus cases climbed by seven, to 692 — all on Oahu. There were 52 active infections in Hawaii and a total of 623 patients considered recovered since the start of the outbreak in February. The state’s coronavirus death toll remains unchanged at 17.

Of the more than 58,579 coronavirus tests conducted so far by state and clinical laboratories in Hawaii, about 1.2% have been positive.

“We either need a vaccine that’s very effective, which would be probably the best thing. But if you can convert the severity of disease to something that’s more like a common cold, I think that would really be helpful,” Shikuma said. “At least prevent symptoms from getting so severe that (people) end up in the hospital.”

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