A Phase 2 clinical trial is getting underway at UC and nearly 20 other sites across the U.S. to determine the safety and efficacy of the drug razuprotafib in treating COVID-19 patients. Researchers say this drug could possibly prevent "long-haulers syndrome."
Razuprotafib is already used to treat diabetes and renal disease. By zeroing in on blood vessels to make them healthier, it's hoped COVID patients can benefit, too.
Early on in the pandemic, researchers realized the coronavirus attached itself to blood vessels of all sizes and could cause damage to any organ. Patients were also at elevated risk of having blood clots.
Razuprotafib increases the levels of the receptor proteins known as Tie2 on the surface of endothelium cells. Those cells line the blood vessels of organs and the drug makes the vessels healthier.
"This is a way to be very, very selective about treatment for COVID-19 and also develop drugs that can be used in complimentary fashion with other drugs, whether it's remdesivir, methylprednisolone or convalescent plasma," says Richard Becker, MD, a UC Health cardiologist and director of the UC Heart, Lung and Vascular Institute.
In this study, up to 180 COVID patients who are hospitalized and receiving supplemental oxygen but not on a respirator will take part nationwide.
Dr. Duncan Hite is co-investigator of the trial at UC and director of Critical Care Services. He says the hope is "that this would be a subset of patients where there's obviously enough abnormalities for there to be an opportunity to have benefit, but where they're not so severely ill that they might be beyond a stage of the illness where the potential benefit would be too hard to see."
Hite emphasizes the trial is not being rushed, and now he and others must determine what dosage is effective.
The drug is an injection right under the skin, and during this Phase 2 trial will be given up to three times a day for up to seven days.
Approval can't come soon enough for some who worry about potential long-term organ damage from COVID. A recent study published in JAMA Cardiology looked at 100 recovered coronavirus patients. Seventy-eight of them had heart abnormalities and 60 had heart inflammation. One hope is to prevent the so-called "long-haulers" syndrome.
A Washington Post op-ed, written by researchers, speculates if we don't solve the lasting effects, COVID-19 could have an even bigger impact on public health and the global economy.