The first clinical trial in Oklahoma seeking a possible treatment for the most severely ill COVID-19 patients launched Thursday in Tulsa based on a promising early study overseas.
Ascension St. John, which will conduct the research at its Clinical Research Institute in its main medical center, said a similar drug showed promise in a small-scale study in China. Researchers hope the drug — typically prescribed for rheumatoid arthritis — will reduce inflammation in the lungs.
“There is a significant likelihood that we’ll have some improvement,” said Dr. Anuj Malik, director of infection control at Ascension St. John. “It may or may not be a 'game changer,' but it certainly has promise in helping the most severely ill individuals.”
The anti-inflammatory medication is intravenously injected once into the patient, who must be severely or critically ill with a positive test for the novel coronavirus to enter the trial. The drug is Sarilumab, and the company sponsoring the research is New York-based Regeneron Pharmaceuticals.
Malik, the trial’s primary investigator, said patients in China showed improvement within three to five days of receiving the medication, including findings on CT scans of the chest, some lab tests and fever.
He said COVID-19 is problematic in that patients who progress to a severe illness probably have a hyper activation of the immune system, which can lead to damage to the body and lungs.
“The idea behind this drug is to target it towards the severe spectrum of the illness so as to reduce the inflammatory injury to the lungs,” Malik said.
The clinical trial is a randomized, double-blind, placebo control study.
Malik said there is no limit on patients in Tulsa, but that Regeneron’s statistical analysis calls for about 50 to 100 participants here. Malik said the company plans to run four to five test sites with about 400 to 500 patients total.
The trial procedures were finalized Wednesday and the first patient in Tulsa enrolled Thursday.
“I would suspect that it will take us at least two to three months to have some preliminary information about how this is going to go and then go from there,” Malik said.
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Corey Jones 918-581-8359