Hundreds of patients in the U.K.’s National Health Service (NHS) will be given the arthritis drug Actemra (tocilizumab) in the world’s largest clinical trial of existing medications repurposed to treat COVID-19, the potentially fatal disease caused by the SARS-CoV-2 coronavirus.
Tocilizumab will be given to COVID-19 patients with severe lung inflammation caused by cytokine release syndrome, often referred to as “cytokine storm.” This inflammation can be deadly as it fills the lungs with fluid, making breathing difficult. Cytokine release syndrome is essentially an overreaction of the immune system which causes a runaway inflammation response.
More than 6,000 COVID-19 patients from over 160 NHS trusts have volunteered to enroll in the trial, which is being run by the University of Oxford. Other drugs being tested in the trial are hydroxychloroquine, Kaletra, dexamethasone, azithromycin and tocilizumab.
Actemra treats the inflammation associated with arthritis by blocking the IL-6 pro-inflammatory cytokine. It is believed it may also be able to treat lung inflammation caused by COVID-19, as China’s National Health Commission has found that COVID-19 patients with severe lung damage have high levels of IL-6.
Actemra is also being tested against COVID-19 in a phase 3 trial in the United States. Roche is collaborating with the US Biomedical Advanced Research and Development Authority (BARDA) in that trial. That trial is examining Actemra’s effect on clinical status, mortality, need for mechanical ventilation and intensive care unit admission.
Reports say that doctors in China had a 95% success rate regarding treating severe COVID-19 symptoms with tocilizumab. The doctors gave the medication to 20 severely ill COVID-19 patients suffering from cytokine release syndrome and said that 19 of the patients were discharged from the hospital within two weeks, and that the 20th patient was recovering well.
Actemra has been linked to numerous severe side effects. The FDA has noted that it could be linked to pulmonary alveolar proteinosis, pulmonary hypertension and interstitial lung disease. A study has linked the drug to 1.5 times the risk of heart failure and stroke, and an investigation found that the FDA was aware of 1,128 reports of Actemra patients dying. That investigation noted that Actemra may be linked to heart failure, pancreatitis, stroke, heart attack and interstitial lung disease.
Actemra’s label was revised in 2019 to include a warning about the risk of liver injury associated with taking the medication.