The goal is to enroll an estimated 330 participants in total across all the testing sites by May 2020. The Baylor site is pulling from Baylor College of Medicine as well as Harris Health System’s Ben Taub Hospital, according to a news release.
“The organ most commonly affected by COVID-19 is the lung, causing pneumonia for some patients and leading to difficulty breathing,” said Dr. Ivan O. Rosas, chief of the pulmonary, critical care and sleep medicine section in the Department of Medicine and the lead investigator at the Baylor site in the release.
The drug Tocilizumab (TCZ) will be tested alongside placebo in a randomized, controlled study, where both the investigator and participant are blinded to who is receiving treatment. Eligible participants, including hospitalized patients diagnosed with severe COVID-19 pneumonia confirmed with chest imaging, will be given an IV infusion with either a predetermined dose of TCZ or a placebo drug and may be given additional dosages if they show no sign of improvement.
The drug is being tested because TCZ could potentially target the body’s immune response to the virus, which is thought to be abnormally increased and described by others as a “cytokine storm,” the hyper-immune response triggered by the viral pneumonia, according to the release.
The working hypothesis from researchers is that because TCZ has been successfully used to treat hyperimmune responses in cancer patients undergoing treatment with immunotherapy, then the drug should have a similar effect to those with severe COVID-19 pneumonia.
Biotechnology company Genentech is sponsoring the trial.