ECU, Vidant begin clinical trial of COVID-19 treatment

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GREENVILLE, N.C. (WNCT) – The coronavirus affects patients in many different ways. 

Health professionals are working on drug treatments to help with lung problems associated with the virus. 

One of the top researchers at East Carolina University’s Brody School of Medicine is leading a local team in a new COVID-19 drug trial.

Their work focuses on fluid that forms in the lungs as a result of COVID-19, it’s hoped the treatment will reduce the need for ventilators to help COVID patients.

210 patients will take part in the study at eight sites across the country, then the researchers will look at the results.

Doctor Paul Cook explains this isn’t a cure to the virus.

Cook says trials like these are necessary, and have the potential to help coronavirus patients. 

“There’s absolutely not a single medication that is approved to treat COVID so because of that we have to do these trials in order to understand which drugs might work and which drugs might not work,” says Dr. Cook. 

There are currently 10 patients enrolled in the trial, so the Vidant and ECU team is looking for another 200 people to be part of their research.

Dr. Cook says the coronavirus pandemic is far from over. 

He says the best way to avoid being a patient is for people to wear their masks when out in public, practice social distancing, and frequently wash their hands.

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GREENVILLE, N.C. (WNCT) A new clinical trial headed by an East Carolina University ­­­­infectious disease specialist at Vidant Medical Center aims to prevent COVID-19 from causing the type of lung damage in patients that is often fatal.

Dr. Paul Cook, chief of the Division of Infectious Diseases at ECU’s Brody School of Medicine, began enrolling patients June 1 in a clinical trial investigating a new treatment aimed at preventing and shortening the duration of Acute Respiratory Distress Syndrome (ARDS).

ARDS is a characteristic of COVID-19 that occurs when fluid builds up in the lungs and prevents oxygen from entering the bloodstream.

ECU is one of only eight sites in the United States participating in the trial, which is a collaboration with pharmaceutical company Eli Lilly and Vidant Medical Center.

The drug, which does not yet have a name but is referred to as LY3127804, is a monoclonal antibody to Angiopoietin-2 (Ang2). 

Ang2 acts on endothelial cells in the lungs, causing them to become leaky. Ang2 levels are known to be elevated in ARDS patients.

The trial will test whether preventing the effects of Ang2 with this monoclonal antibody can reduce the progression to ARDS or the need for ventilators in COVID-19 patients.

Prior to COVID-19, Eli Lilly was developing the drug to treat ARDS associated with cancer and cerebral malaria, a condition most prevalent in Africa.

Basically, by getting this one-time infusion, this monoclonal antibody binds to this substance Angiopoeitin-2 and prevents it from causing the damage in the lung that is responsible for the Acute Respiratory Distress Syndrome,” Cook said, adding that most of the deaths attributed to COVID-19 are related to complications from ARDS. “We suspect that this drug will reduce development of ARDS, reduce need for mechanical ventilation, reduce hospital days and reduce mortality related to Covid-19.”

Monoclonal antibodies are typically low risk in terms of side effects that patients experience, Cook said. This, coupled with an understanding of how Ang2 can cause ARDS, gave Cook confidence in the drug’s safety and potential for helping COVID-19 patients.

“A certain percentage — maybe 15-20 percent of people (with COVID-19) are going to get more than just minor symptoms and they get this cytokine storm that leads to the pulmonary problems,” Cook said. “Those people end up in the hospital. They end up — a lot of them — on ventilators, most of them on oxygen, and some of them die. That’s what we’re trying to prevent. This drug, by acting on this Angiopoeitin-2, particularly if it’s given early enough, is likely to reduce the morbidity and severity of the disease.”

The treatment protocol has been approved by the FDA for further study. Cook said he hopes to enroll around 30 patients within a four- to six-week period for the double-blind placebo-controlled trial.

Enrollment in the trial is voluntary and free of charge for patients who must exhibit moderate to severe symptoms of COVID-19 in order to be considered.

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