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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New coronavirus causing COVID-19 cases
United States: 383,256 cases 12,021 deaths
Spain - 140,510 cases, 13,798 deaths
Italy - 132,547 cases, 16,523 deaths
France - 98,984 cases, 8,926 deaths
China - 82,718 cases, 3,335 deaths
Iran - 62,589 cases, 3,872 deaths
United Kingdom - 52,301 cases, 5,385 deaths
Netherlands - 18,926 cases, 1,874 deaths
Germany - 103,375 cases, 1,810 deaths
Central and South America - 1,162 deaths
Middle East (outside Iran) - 867 deaths
South Korea - 10,331 cases, 192 deaths
Japan - 3,654 cases, 85 deaths (712 cases, 10 deaths from cruise ship)
India - 4,314 cases, 118 deaths
Poland - 4,201 cases, 98 deaths
Sub-Saharan Africa - 6,000+ cases, 60+ deaths
Israel - 8,611 cases, 51 deaths (West Bank/Gaza: 1 death)
Russia - 6,343 cases, 47 deaths
Greece - 1,735 cases, 73 deaths
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