Baylor College of Medicine is a research site for a clinical trial evaluating the therapeutic benefit and safety of Tocilizumab (TCZ), an immunomodulator drug, in patients with severe COVID-19 pneumonia.
The Baylor site is enrolling patients who are hospitalized at Baylor St. Luke’s Medical Center and Harris Health System’s Ben Taub Hospital.
“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.
Rosas explains that TCZ potentially targets 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. The main goal of the treatment is not to eliminate the virus, but to reduce the “cytokine storm,” which in some patients could be more detrimental than the original infection.
Since TCZ has been successfully used to treat hyperimmune responses in cancer patients undergoing treatment with immunotherapy, investigators speculate that it will have a similar effect in those affected with severe COVID-19 pneumonia.
The clinical trial is a randomized, placebo controlled study where both the investigator and participant are blinded to who is receiving treatment. Participants will be given an IV infusion with either a predetermined dose of TCZ or a placebo drug. Additional dosages may be given if the patient shows no sign of improvement. Eligible participants include hospitalized patients diagnosed with severe COVID-19 pneumonia that has been confirmed by a PCR test and chest imaging.
Patients will be monitored for a clinical response to the treatment and whether the drug is safe and effective. The treating and investigator team will closely monitor disease progression, duration of hospitalization, need for critical care and other supportive treatments.
This multicenter study aims to enroll an estimated 330 participants and estimates completion of enrollment in early May of 2020. Besides the research site at Baylor College of Medicine in Houston, the trial is taking place in more than 50 sites across the United States, Europe and Canada.
The trial is sponsored by Genentech, a biotechnology company that is a member of the Hoffmann-La Roche group.