VCU tests third COVID-19 drug, this time targeting inflammation
Researchers hope drug will help subset of patients with pneumonia, cytokine release syndrome
Researchers at VCU Health now are conducting trials on a third drug to help treat COVID-19, a medication that suppresses inflammation in people with a type of juvenile arthritis.
Canakinumab is already approved by the U.S. Food and Drug Administration for use in arthritis patients, but a new study — launched April 29 at VCU — is taking place to see if the drug can help COVID-19 patients who are suffering from pneumonia and inflammation, which can prove deadly. Ultimately, 450 patients will be included in the study worldwide, including up to 20 people at VCU.
Physicians in China observed that a subgroup of COVID-19 patients were getting sicker 10 days into the disease, and many were dying from an inflammatory response to the disease, such as heart attacks or strokes. Patients taking part in the trial have virus-induced cytokine release syndrome, an inflammatory illness that can cause organ failure.
Most patients who are likely to suffer from inflammation connected with COVID-19 are older people or patients with underlying illnesses like hypertension or diabetes. Canakinumab blocks Interleukin-1β, a protein that causes inflammation, which can then increase to levels that cause organ failure.
This trial joins three other COVID-19 studies at VCU: two trials of remdesivir, a drug developed to treat the Ebola virus, and one study of sarilumab, a medication that treats rheumatoid arthritis.
Remdesivir was authorized by the FDA for emergency use on severe virus patients May 1, after 5-day and 10-day regimens proved successful at VCU and other hospitals. Between 55% and 65% of patients in the remdesivir trial were fully recovered within 28 days, and the mortality rate was between 8% and 11%.
Dr. Antonio Abbate, a VCU Health cardiologist and the canakinumab study’s principal investigator, explained that his study is double-blind, meaning that neither the patient nor the researcher knows if the patient is receiving the drug or a placebo. “That’s the gold standard for FDA,” he said, “eliminating bias on both sides. It does guarantee that level of certainty.”
He expects to have results within a few months.
He and his partner, pharmacy professor Benjamin Van Tassell, work closely with the other research teams at VCU Health, evaluating which patients are best suited for a certain trial. VCU typically has between 30 and 50 virus patients at a time, Abbate said.
For instance, a patient in the canakinumab trial cannot be on a ventilator, although they must show symptoms of pneumonia and may receive some oxygen support.
“They’re at risk for a ventilator,” Abbate said. Pneumonia, in addition to other virus symptoms, “puts patients at greatest risk.” He is looking for patients’ fever to reduce, respiratory improvement and less inflammation in response to the drug.
“A little bit of inflammation can trigger more inflammation, which triggers more and more,” Van Tassell said in a statement. “And that seems to be the most dangerous part of a COVID-19 infection: when you enter into this hyper-inflammatory state.”
“I am hopeful,” Abbate said. The drug already has been proven to work on inflammation in arthritis patients, “so it’s reasonable to expect it will work on inflammation also in coronavirus infections.”