ST. PAUL — HealthPartners Institute is helping test a drug that could limit ventilator needs for patients with severe cases of COVID-19.
CalciMedica of San Diego developed CM4620-IE to help patients with acute cases of pancreatitis and it has been proven safe for that use.
Now, the intravenous drug is being explored as a treatment for coronavirus effects of lung inflammation and lung damage. This drug is intended to stop “cytokine storm,” which is when the immune system damages a body’s own cells.
Regions Hospital in St. Paul began a clinical study last week after the drug received fast-track approval for investigations from the FDA. The Henry Ford Hospital in Detroit is expected to start a trial this week and additional study sites come be added.
“There is a dire need for a fast-acting, potent treatment for patients with severe COVID-19 pneumonia,” said Dr. Charles A. Bruen at Regions Hospital in a statement. “… (The drug’s) rapid onset makes it ideal for acute settings. It has the potential to prevent the development of (acute respiratory distress syndrome) in patients with severe COVID-19 pneumonia and reduce the need for ventilators at a time when there is a shortage of ventilators in healthcare facilities across the U.S.”
The study will include up to 60 hospitalized patients with COVID-19 who have moderately low blood oxygen levels but don’t need a ventilator.
The randomized test will have 40 patients receive three, four-hour infusions over three days and 20 patients will receive standard care without the drug. Patients will be followed for 10 days or until discharge and contacted after 30 and 60 days.