HOUSTON—The Michael E. DeBakey VAMC in Houston and the Bruce W. Carter VAMC in Miami are among nearly 70 locations across the world participating in a randomized double-blind clinical trial of an immunomodulator, tocilizumab, for patients with severe pneumonia associated with COVID-19.
“COVID-19 is known to cause extensive damage in the lungs,” said study co-investigator Lavannya Pandit, MD, a pulmonologist and critical care physician at the Houston VAMC. “This often leads to difficulty breathing and, eventually, pneumonia. Pneumonia triggers a hyperimmune response that we are seeing can be more detrimental to some patients than the original infection.”
Tocilizumab (TCZ) dials down the body’s immune response and is used to treat autoimmune diseases such as rheumatoid arthritis, hyperimmune responses in cancer patients, and cytokine release syndrome induced by chimeric antigen receptor T-cell therapy.
“The hypothesis is that TCZ can prevent the inflammatory response in COVID pneumonia that leads to uncontrolled inflammation and respiratory failure,” said Houston VAMC co-investigator Barbara Trautner, MD, an infectious disease specialist.
Participants in the trial must be hospitalized with severe COVID-19 pneumonia characterized by dangerously low blood oxygen levels and confirmed by chest imaging. Patients cannot be on ventilation at enrollment.
Participants receive one injection of tocilizumab or placebo plus current standard of care. At the VA, that generally means a combination of remdesivir and dexamethasone, based on positive outcomes in earlier trials.
An earlier phase 3 trial of tocilizumab in hospitalized patients with severe COVID-19 associated pneumonia did not meet its primary endpoint of improved clinical status or its secondary endpoint of reduced mortality, the drug’s manufacturer announced on July 29. The current trial is assessing whether tocilizumab reduces the number of patients who require mechanical ventilation, with a number of secondary endpoints, including mortality, disease progression, length of hospitalization, and need for critical care.
Because of trials like this, “the treatments we offer for COVID-19 three months from now will be very different than what we offer today because of scientific trials like this,” said Trautner.
The Houston VAMC enrolled 16 patients in the trial, ranging in age from their late 30s to the late 70s. The Miami VAMC enrolled two patients, aged 48 and 69 years old. All participants are monitored for 28 days for their response to the therapy.
“The veterans we are enrolling in this study are eager to join the fight against COVID-19,” Trautner said, “and we are happy to provide them this opportunity and do our part. VA offers cutting-edge treatments and top-quality care for Veterans with COVID-19. Participating in this clinical trial allows our veterans the opportunity to contribute to scientific progress.”