Progress is being made in the fight against COVID-19. Regeneron Pharmaceuticals and Sanofi recently announced the launch of a clinical program to evaluate the effectiveness of Kevzara in those hospitalized with coronavirus infections. If you have watched the news amidst the coronavirus pandemic, you have likely heard of antibody testing. Kevzara is one of those antibodies. Kevzara binds and blocks the IL-6 receptor to inhibit interleukin-6, also referred to as IL-6. IL-6 likely helps catalyze the excessive inflammatory response within the lungs of those suffering from a severe coronavirus infection.
About the Trial
The Kevzara trial will commence at New York medical centers. The aim of the trial is to determine the efficacy and safety of Kevzara’s use for supportive care. The trial will be double-blind with upwards of 400 patient participants. The initial part of the trial includes COVID-19 patients from 16 sites across the country. It is hoped Kevzara reduces patient fever and the need for additional oxygen.
The second component of the trial will gauge the anticipated improvement in long-term outcomes in terms of death prevention, decreasing the necessity of mechanical ventilation along with supplemental oxygen, and the need for hospitalization. Sanofi representatives have also noted the company will expedite initial Kevzara trials in other countries across the ensuing weeks with a focus on locations hit the hardest by COVID-19, such as Italy and Spain.
Kevzara Provides Much Needed Hope
Regeneron and Sanofi teamed up to develop Kevzara, a completely human monoclonal antibody. Kevzara binds to the IL-6 receptor, likely inhibiting the IL-6’s mediated signals. IL-6 is a protein generated in large amounts in those suffering from rheumatoid arthritis. This protein has been tied to the destruction of joints, disease activity, and additional systemic challenges.
It is hoped Kevzara will minimize the heightened inflammatory immune response caused by coronavirus. This injectable prescription medicine might not prove capable of defeating COVID-19, yet it certainly provides infected individuals with much needed hope. This hope is fueled by a Chinese trial in which 21 patients treated with Kevzara enjoyed rapid fever reduction. Exactly three-quarters of these patients found their need for additional oxygen was meaningfully reduced after taking another IL-6 receptor antibody. Chinese authorities subsequently approved the use of the IL-6 inhibitor to treat individuals dealing with critical disease.
Additional Trial Details
The double-blind, randomized trial will incorporate the use of a placebo to get an accurate sense of whether Kevzara proves effective for adults who have been hospitalized with COVID-19 complications. However, only those who have been hospitalized with critical or severe cases of the virus will qualify for the trial. Patients who do not have fever and pneumonia will not qualify for participation. Once the Kevzara dose is provided, the patients will be closely studied for a two-month period or until the point at which they are discharged from the hospital.
The second phase of the trial randomizes the patients 2:2:1 in three groups: a placebo group that serves as a point of comparison, a low dose Kevzara group, and a high dose Kevzara group. It is hoped those provided with Kevzara will enjoy fever reduction as well as a reduced need for additional oxygen. The third phase of the trial will help gauge endpoints and the efficacy of specific doses. The second, more expansive component of the trial will analyze patient improvement in the context of long-term outcomes such as the prevention of death or the decreased need for the use of mechanical ventilation, additional oxygen and hospitalization.
Sources
- http://www.news.sanofi.us/2020-03-16-Sanofi-and-Regeneron-begin-global-Kevzara-R-sarilumab-clinical-trial-program-in-patients-with-severe-COVID-19
- https://www.technologyreview.com/s/615436/the-coronavirus-test-that-might-exempt-you-from-social-distancingif-you-pass/
- https://www.ncbi.nlm.nih.gov/pubmed/22029668