Northwestern Memorial hospital taking part in global COVID-19 drug trial, and so far, so good
Editor's note: This story has been corrected to say 1,200 patients nationwide will be recruited for the trial.
Northwestern Memorial Hospital is taking part in a worldwide study of a rheumatoid arthritis drug as a possible treatment for critically ill COVID-19 patients.
Since March, the Chicago hospital has enrolled patients in a global clinical trial of a drug called sarilumab, known by the brand name Kevzara. More than 1,200 patients nationwide will be recruited fo the study.
According to Dr. Richard Wunderink, Northwestern's medical intensive care unit director, some with severe cases of COVID-19 develop a dangerous immune system response called a cytokine storm.
In such cases, the immune system overreacts and attacks the body instead of the virus.
"Cytokines are molecules in the body that are part of our normal defense against infections, but they can have extreme elevations and lead to injury of a variety of organs, particular the lung," Wunderink said Friday.
Cytokine storms can cause acute respiratory distress syndrome, acute kidney injury, shock, abnormalities in the blood clotting system and a variety of other manifestations, the doctor said.
Sarilumab blocks the body from making an inflammatory cytokine called interleukin-6, or IL-6, by binding to the IL-6 receptor. The drug is used to treat adults with moderately to severely active rheumatoid arthritis.
Excessive amounts of IL-6 may play a role in causing acute respiratory distress, preliminary evidence shows. The goal is to determine if the drug helps to calm the overactive inflammatory responses in the lungs when damaged by COVID-19.
The randomized, double-blind study began as a Phase II trial.
Researchers compare the response of those who receive sarilumab and a control group of patients given a placebo. Northwestern is using special diagnostic tests developed in-house to look for infection in patients receiving sarilumab, the hospital said in a release.
Researchers in China gave a similar drug to a small number of people to positive effect, according to Wunderink.
It's early, but the Northwestern trial already has produced promising results.
"There is a safety monitoring group that has looked at the data and basically said we're safe to continue to enroll," Wunderink said. "So, in some ways that initial component of seeing that this is safe to give in very sick patients has pretty much been validated."
More testing is needed to determine if the medication should be used routinely and to discover possible side effects.
"All this data is accumulating," Wunderink said. "Ultimately, when we break the blind, we'll know if there are any additional safety signals there. But it really is appearing that it's safe to use in very ill patients. The real question is, Is it leading to better outcomes?"
Northwestern patients are also eligible to join an international clinical trial for remdesivir, an antiviral drug developed to treat Ebola.
The hospital also is studying other experimental antibiotics for select patients.