Rheumatoid arthritis drug Kevzara will be used in an international study of patients infected with the new coronavirus and suffering from acute respiratory distress syndrome, Regeneron Pharmaceuticals and Sanofi announced Monday.
The trial will kick off in disease hotspot New York City, expanding to a total of 16 U.S. sites and enrolling 400 patients. The companies aim to study whether Kevzara can reduce fever and the need for supplemental oxygen in patients severely affected by COVID-19, the illness caused by the virus.
Roche’s Actemra, which has a similar mechanism of action, has been tested in Chinese patients and led to a decrease in fever and oxygen use, prompting the country to include it in treatment guidelines. The drug’s use shows the speed with which global public health officials are willing to consider using drugs off-label in order to address the coronavirus pandemic.
A vaccine to prevent infections of the novel coronavirus SARS-CoV-2 is likely a year or more away — at best — and treatments specifically designed to fight this virus or its complications are similarly far off.
Possible treatments, however, could already be available in the form of marketed or existing experimental drugs. Global public health officials, eager for a weapon to use in the midst of a global pandemic, are showing a willingness to be flexible in terms of the clinical trials and the evidence needed to prove treatments’ effectiveness.
Earlier this month, China OK’d the use of Actemra in patients with lung complications and high levels of interleukin-6, or IL-6, a protein that mediates inflammatory and immune response. High levels of IL-6 have been associated with a greater risk of death in patients with community-acquired pneumonia.
Actemra and Kevzara both block IL-6 and are prescribed for rheumatoid arthritis, a disorder in which an overactive immune system creates joint-damaging inflammation and pain. Actemra is similarly approved in conjunction with cancer cell therapy, which can sometimes trigger an immune reaction known as cytokine release syndrome.
The U.S.-based Kevzara trial is a two-part design that will initially evaluate fever and oxygen use in patients with acute respiratory distress syndrome, or ARDS. Two different dose levels will be used and compared to a placebo.
Longer-term, the trial hopes to measure prevention of death, use of ventilation, supplemental oxygen or hospitalization, but the design will be “adaptive” to determine the number of patients that will be followed and the endpoints to be used. ARDS often causes permanent lung damage and can lead to early death.
The trial aims to enroll 400 patients in the U.S. Regeneron’s partner Sanofi will handle international trial sites, naming Italy as one likely location for testing in coronavirus patients.
To get the trial underway quickly, Regeneron and Sanofi worked closely with the Food and Drug Administration and the Biomedical Advanced Research and Development Authority, the division of HHS involved in preparing for natural and man-made biological threats.