MINNEAPOLIS — Medical experts have for weeks tested the degree to which anti-viral treatments such as hydroxychloroquine and remdesivir can prevent the coronavirus from gaining ground inside a patient’s body.
With a boost from Bill Gates, two doctors at the University of Minnesota Medical School are challenging the medical community to try a different approach — treatment studies involving common high-blood pressure medications.
“This is different than doing what most of the other clinical trials are trying to do right now,” said Dr. Michael Puskarich. “We’re looking at more of the downstream consequences of the virus.”
In other words, “we’re not preventing the virus, but we’re preventing the lung injury,” he said. “And in patients who already have lung injury, can we treat the lung injury, and prevent it from getting worse?”
The doctors have launched two multi-site inpatient and outpatient clinical trials involving the drug Losartan, “a readily available, cheap, FDA-approved, generic drug with potential efficacy against COVID-19,” said Dr. Christopher Tignanelli, in a written statement.
Tignanelli is an assistant professor in the medical school’s division of acute care surgery, and Puskarich is an associate professor in the Department of Emergency Medicine and an emergency physician at Hennepin Healthcare/HCMC.
The doctors believe Losartan will block receptors, or cell doorways, that the chemical angiotensin II uses to elevate blood pressure, which in excess can lead to lung damage. The hope is that Losartan might bind to an enzyme and block the extra angiotensin II, thereby preventing the lung injury.
“(Angiotensin II) gets very, very high in patients with COVID, at least more severe COVID,” Puskarich said. “I am more optimistic about this project than almost any trial I’ve worked on previously, but we need to to do the trials.”
Inpatient and outpatient
The first trial involves 200 patients hospitalized with COVID-19-related pneumonia. The inpatient trial, funded by the COVID-19 Therapeutics Accelerator Fund, will take place at M Health Fairview’s Bethesda Hospital in St. Paul and HCMC. The doctors expect to add 5 to 10 sites nationwide in coming weeks.
The accelerator was launched by the Bill and Melinda Gates Foundation, Wellcome and Mastercard, with funding from other public and philanthropic donors.
Funded by the Minnesota Partnership, an outpatient trial for patients with less serious symptoms will enroll 500 patients at M Health Fairview hospitals, the Mayo Clinic and HCMC. The doctors are seeking funding to expand the outpatient trial nationally.
Puskarich noted that blood pressure medications have drawn increasing interest in medical literature.
“A study in China looking at patients who were on Losartan and that family of blood pressure medicines found they did better than patients who were on other blood pressure medicines,” he said. “But it’s a leap to say, ‘if you’re not on this drug, you should start taking it.'”
What's the risk?
What’s the risk? Losartan and other blood pressure medicines can lower blood pressure to dangerous levels or damage the kidneys. In other words, don’t try this at home without a doctor’s monitoring and guidance.
“These drugs have side effects, and could theoretically make things worse,” Puskarich said.
The doctors are hoping to have preliminary results to report by mid-to-late summer, and that’s a highly accelerated schedule.
“In normal times, a clinical trial like this would take years,” Puskarich said.