UC San Diego Health has launched a clinical trial to determine whether tocilizumab, a drug marketed as Actemra to treat rheumatoid arthritis and other inflammatory disorders, might have therapeutic value for COVID-19 patients with serious lung damage from coronavirus infections.
“There are no approved therapies for COVID-19 beyond symptomatic treatment,” Dr. Atul Malhotra, research chief of pulmonary, critical care and sleep medicine at UCSD Health, said in a statement. “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.”
The randomized, placebo-controlled trial will enroll about 330 participants at nearly 70 sites across the world. For its arm of the trial, UC San Diego will recruit up to 20 participants. Funding and resources for the trial are provided by pharmaceutical company Genentech/Roche, which makes Actemra.
Tocilizumab, an immunosuppressive drug, works by blocking cellular receptors for interleukin-6, a small protein, or cytokine, 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, generating a “cytokine storm” that can lead to potentially life-threatening damage to lungs and other organs. Cytokine storms have been linked to several 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.
In the early days of the COVID-19 coronavirus outbreak last year in Wuhan, China, Chinese physicians used tocilizumab to treat a small number of COVID-19 patients who had 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.
“The endpoints or questions we’re seeking to answer are these: Does tocilizumab improve the health and clinical status of treated COVID-19 patients?” Malhotra said. “Does it reduce the mortality rate due to COVID-19 pneumonia? Does it reduce the need for mechanical ventilation or need for patients to go into intensive care units?”
The estimated completion date for the study is Sept. 30. ◆