A relatively new blood filtration technology under trial at the Southeast Georgia Health System in Brunswick shows promising results in helping COVID-19 patients in critical condition.
Called the Seraph 100, the machine mimics natural bodily functions to remove select pathogens from the bloodstream, including the COVID-19 virus, according to its manufacturer, ExThera Medical.
Keith McCrea, chief scientific officer at ExThera, said the Seraph has been in development for several years for use on many different types of viruses. ExThera was working with the U.S. Food and Drug Administration on the terms of a medical trial in April 2020.
“We have been working with the FDA for several years on a clinical trial program, and prior to COVID-19 we were looking at a viremia application, which was CMV, or cytomegalovirus, and a bacteremia program to address the drug-resistant bacteria crisis the world is in,” McCrea said. “We were getting pretty close to agreeing with the FDA on the trial design for both those programs and then the COVID-19 hit.”
A few months into the COVID-19 pandemic, the FDA authorized the treatment for emergency use. In May, the first official trials began and in June ExThera received a U.S. Department of Defense research contract to fund further development.
Multiple treatments exist for COVID-19, but McCrea said the Seraph could fill a crucial gap.
Monoclonal antibodies, laboratory-made proteins that also mimic bodily functions, are used to treat COVID-19 patients that don’t need hospitalization. The drug remdesivir may help less severe cases recover quicker, and dexamethasone, a steroid used to treat inflammation, has been shown to help in very acute cases.
The blood-filtering process employed in the Seraph system fills that gap in treatment methods between moderate and very severe cases of COVID-19, intervening in quickly declining patients and heading off the need for a ventilator.
“If a patient is placed on a device as they’re deteriorating and doctors determine that intubation or a mechanical ventilation is imminent, we’re having very high success in being able to prevent the need for mechanical intervention,” McCrea said.
“It’s interesting that this is the gap where this isn’t a well-known treatment.”
Initially, the trial was to include a random control group. Due to the severity of the outbreak and the disease itself, the FDA had concerns about using a control.
In scientific tests, a control group is not given the real drug or treatment. This ensures the subject of the trial is actually doing what it is supposed to do and its effects are not simply a placebo.
“There’s obviously an ethical consideration,” McCrea said. “If a (randomized) study determines the device is successful at treating patients, the patients who were forced into a control group where they could not get the treatment, in essence we withheld care from those patients.”
Rather than the randomized trial, McCrea said ExThera is conducting a trial in which every participant receives treatment with the Seraph.
As of Friday, he said 232 people have been selected to take part in the trial and around 17 hospitals are involved, including SGHS.
Filling every gap in treatment is important as it’s likely going to take months for the COVID-19 vaccine to be widely distributed. After only a few days, the Coastal Health District announced that it was no longer taking appointments for COVID-19 vaccinations due to incredibly high demand.