Denver doctors get FDA approval to start COVID-19 treatment study

Colleen Flynn

DENVER (KDVR) — A family of medical doctors received U.S. Food and Drug Administration approval to proceed with a study that will investigate whether the drug Alteplase (or tPA) may be effective in dissolving microscopic blood clots found in the lungs of COVID-19 patients.

“We believe this is pivotal in being able to have patients come off the ventilator,” said Dr. Gene Moore, a trauma surgeon at Denver Health. Moore is working with his two doctor sons, Hunter and Peter, as well as researchers affiliated with Harvard and MIT.

The FDA letter, sent to Moore last week, indicates the FDA conducted a safety review of the researchers’ protocol and concluded the doctors should be able to proceed with their investigation into the drug that is traditionally used for stroke and heart attack treatments.

The doctors said they could begin administering the medication to qualified patients who have severe lung injuries – and are on ventilators – as early as Wednesday.

“As someone that’s been taking care of a lot of these patients in the ICU, we’ve seen a lot of patients that have been on a ventilator for a long period of time. We don’t have a lot of therapies that we know will actually help them,” said Dr. Peter Moore, Gene’s son, who is a pulmonary sciences and critical care fellow.   

“We don’t know if this therapy will help them, but we certainly have seen a lot of blood clots in patients – whether it’s big blood clots or small blood clots – in autopsy series, so we’re hopeful that a medicine that can help dissolve blood clots might make their lung injury resolve quicker and hopefully, we’ll have a treatment that works for them,” he said.

Dr. Gene Moore said COVID-19 has become “alarming” due to reports of relatively younger adults forming blood clots in their brains.

The FOX31 Problem Solvers reached out to several metro-area hospital groups about COVID-19 patients who have experienced clots.

Stephanie Sullivan, who represents HealthONE in Denver, said some infectious disease physicians at the health group’s hospitals saw several early cases of clotting in the deep veins and pulmonary embolism occurring in patients who were taking  a preventive blood thinner therapy. 

Dr. Stephen Cobb, the Chief Medical Officer for Centura Health in metro Denver, told FOX31 that “patients with COVID-19 illness are more likely to get blood clots due to hypercoagulability. Our providers have seen this across numerous locations throughout our 17 hospitals.”

“While many have focused on the proclivity to form blood clots. Our unique interest in our research has been focused on how to break these clots down,” said Dr. Gene Moore. 

Moore said the human body naturally makes and breaks down blood clots. However, the COVID-19 disease makes clots more frequently than normal, and “even more importantly, we don’t break them down,” he said.  “So these clots form, and they stay where they are formed.”

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