Researchers at UC San Diego Health have begun a portion of a global clinical trial to assess whether a medication used to treat rheumatoid arthritis and other inflammatory disorders might also have therapeutic value for COVID-19 patients who have developed or are at high risk of developing serious lung damage from the infection.
Tocilizumab, marketed as Actemra, is an immunosuppressive drug used primarily to treat rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of the disease in children. The antibody-based therapy works by blocking cellular receptors for interleukin-6, a small protein that plays an important role in triggering inflammation as an early immune response to disease.
In some patients with COVID-19, however, the immune response runs amok, overexpressing the protein, which can lead to potentially life- threatening damage to lungs and other organs. This has been linked to a number of inflammatory diseases, from respiratory conditions caused by coronaviruses such as SARS and MERS to some forms of influenza to non-infectious diseases such as multiple sclerosis and pancreatitis.
Previous research has suggested elevated levels of the protein are associated with higher mortality in people with community-acquired pneumonia. According to UCSD Health researchers, in the early days of the novel coronavirus outbreak in Wuhan last year, Chinese physicians used tocilizumab to treat a small number of COVID-19 patients with serious lung damage, and reported promising results. The Chinese National Health commission now includes tocilizumab in its guidelines for treating COVID-19-related pneumonia and other lung issues.
"There are no approved therapies for COVID-19, beyond symptomatic treatment," said Dr. Atul Malhotra, research chief of pulmonary, critical care and sleep medicine at UC San Diego Health. "But there is increasing evidence that COVID-19 can dramatically impact patients in many different ways, not least by severely damaging inflamed lungs."
"The mechanism of tocilizumab suggests a way to dampen and halt that inflammatory response, which might reduce the need for more extreme medical interventions, such as mechanical ventilation, and greater risk of chronic injury and death," Malhotra said.
The trial will enroll approximately 330 participants at nearly 70 sites across the world. For its arm of the trial, UC San Diego will recruit up to 20 participants.
