ST. LOUIS — Washington University School of Medicine announced on Friday a new clinical trial to investigate three anti-inflammatory drugs in patients with COVID-19.
The trial, which is funded by the National Institutes of Health, aims to enroll 2,000 patients hospitalized with moderate to severe COVID-19, and is expected to last six months.
Researchers will soon begin screening patients at Barnes-Jewish Hospital to determine if they are eligible to participate. There will be about 60 more sites added across the U.S., and about 40 more internationally, most of those in Latin America.
The trial will enroll hospitalized COVID-19 patients, including individuals whose cases are serious enough that the patient needs oxygen, or has X-rays that show signs of pneumonia, said the trial’s principal investigator, Dr. William Powderly. Powderly is a professor of medicine at Washington University School of Medicine, and director of the school’s Division of Infectious Diseases.
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“In those patients, we think what is happening, and the reason they are progressing and having more severe symptoms, is actually not that the virus is replicating and multiplying and damaging their lungs directly,” Powderly said. “But rather that the immune response to the virus is abnormal, or is harming the patient.”
The drugs will be tested as ways to tamp down patients’ immune responses to the virus. Researchers hope the drugs will result in shorter hospital stays, and decreased severity of respiratory symptoms.
All of the patients will receive remdesivir, an antiviral drug. They will also receive either a placebo, or one of the three drugs in the study. Patients can also receive other treatments, such as steroids.
“This is still, obviously, a serious illness, and people are dying,” Powderly said. “We’re trying to both study these approaches rapidly, and as efficiently as possible, while giving patients the best possible treatment that they would normally get.”
The drugs in the trial are infliximab, abatacept and cenicriviroc.
Infliximab is approved by the Food and Drug Administration for treatment of severe chronic inflammatory conditions such as rheumatoid arthritis. Abatacept is FDA-approved for treatment of certain forms of arthritis.
The third drug, cenicriviroc, is in clinical trials for treatment of liver inflammation. Powderly said researchers have a reasonable understanding of how cenicriviroc works, but it is still an investigational drug.
The trial is designed to be adaptive, so drugs that don’t show promising results can be eliminated and replaced during the study.
“It really has been an all-hands-on-deck approach to getting these complicated studies out and available as quickly as possible,” Powderly said.
These maps and charts show the spread of COVID-19 in Missouri and Illinois.
Annika Merrilees • 314-340-8528 @annie3mer on Twitter email@example.com