BUFFALO, N.Y. — There are currently no U.S. Food and Drug Administration-approved drugs for treating patients with COVID-19.
However, there are drugs approved to treat other diseases that might help coronavirus patients.
An arthritis drug is among the latest being tried out to see if it can help, and some of the research into that will be conducted in Western New York.
Roswell Park Comprehensive Cancer Center and the University at Buffalo will participate in clinical trials to determine if Sarilumab, which is sold under the brand name Kevzara, can be helpful in treating critically ill Coronavirus patients.
“We are specialists who treat patients with cancer, but we are also specialists in clinical trials, clinical research and developing drugs for patients,” explained Dr. Igor Puzanov, director of the Early Phase Clinical Trials Program at Roswell Park.
Dr Puzanov also noted that UB has expertise regarding viruses.
“We realized we could complement each other,” said Dr. Puzanov.
The FDA agreed, and it selected Roswell and UB to be one of 16 groups across the nation who will partake in the clinical trials involving 400 patients.
Which patients will participate?
Puzanov estimated the local portion of the trials will involve perhaps two dozen patients who are critically ill.
As such they must be hospitalized with laboratory confirmed COVID-19 that is classified as severe.
“Severe would be defined in this case as someone already needing oxygen,” Puzanov said.
According to the trial study guidelines, patients also must have pneumonia and fever.
“So, if you get COVID-like, mild symptoms, you are not a candidate for this,” Dr. Puzanov said.
What is this drug?
Sarilumab is normally used to treat inflammation associated with rheumatoid arthritis.
Hopes that it could help COVID-19 patients arose after 21 patients in China experienced rapidly reduced fever, and they no longer needed supplemental oxygen within days of being given the drug.
It is believed it could have possibly helped by preventing the immune system in those patients from over reacting and inflaming the lungs, which can lead to pneumonia and eventually respiratory distress syndrome.
However, while the findings from China may have been encouraging, they were not part of a properly designed randomized trial to understand the true impact.
The trial which Roswell and UB are participating in will be the first controlled trial in the United States to evaluate the effect of IL-6 inhibition in COVID-19 patients.
Looking for a cure
Meanwhile, Dr. Puzanov indicated that Roswell may soon be experimenting with combinations of certain immunomodulators or immune-modifying drugs, to see if they can help patients in the early stages of COVID-19, and possibly prevent their symptoms from becoming more serious.
These drugs are often given to cancer patients to boost their immune systems.
“We actually see some good data with cancer, and we know that they can boost immune systems. So now the question is, can they boost the immune system just right with patients with COVID-19? And if they can, then could somebody who just got infected have their immune system boosted so that it kills the virus right away and they never get into trouble whatsoever?”