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The drug being used, sarilumab, may be useful in reducing the acute respiratory distress syndrome seen in patients with severe COVID-19 infection.
Vall d'Hebron Barcelona Hospital Campus has already started the inclusion of patients with severe COVID-19 in an international clinical trial with sarilumab (Kevzara), a drug developed by Sanofi and Regeneron and whose original indication is rheumatoid arthritis. Vall d’Hebron has been the first center in Spain to be activated for the trial and has enrolled the first patient in Catalonia. The trial will be coordinated by doctors Benito Almirante, head of the Vall d'Hebron Infectious Diseases Service and head of the Infectious Diseases research group at the Vall d'Hebron Research Institute (VHIR) and Ricard Ferrer, head of the Intensive Care Service at Vall d'Hebron and head of the research group on Shock, Organic Dysfunction and Resuscitation (SODIR) at the VHIR.
Along with Vall d'Hebron, four other state hospitals participate: the Hospital Clínic in Barcelona and the hospitals La Paz, Ramón y Cajal and Gregorio Marañón in Madrid. And also centers in Italy, Germany, France, Canada, Russia and the United States.
The goal of the study is to determine if sarilumab improves the life-threatening complications of severe respiratory infections caused by COVID-19 by counteracting overactive inflammatory responses in the lungs when the virus attacks them. This drug has the ability to inhibit interleukin-6 (IL-6), which may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 infection.
This Phase 2/3, randomized, double-blind, placebo-controlled trial uses an adaptive design to evaluate the safety and efficacy of Kevzara in adults hospitalized with serious complications from COVID-19. To enter the trial, patients must have pneumonia and be hospitalized with laboratory-confirmed COVID-19 that is classified as severe or critical, or who are suffering from multi-organ dysfunction. It is expected to enroll approximately 300 patients, depending on the status of the COVID-19 outbreak and the proportion of patients with severe COVID-19.
Preliminary data from a simpler, single-arm study conducted in China is encouraging as patients treated with a similar drug experienced significant improvement within a few days.
On the other hand, Vall d'Hebron has also participated, since last week, in two clinical trials to treat cases of coronavirus with Remdesivir, a drug that was used during the Ebola outbreak in 2014. These two clinical trials are indicated for patients with severe and moderate respiratory diseases. The promoter of the trials is the pharmaceutical company Gilead, specialized in antiviral drugs for HIV, hepatitis B and C, and influenza). These two studies are also coordinated by doctors Benito Almirante and Ricard Ferrer.
In addition, Vall d’Hebron continues to study its participation in other clinical trials of promoters, both national and international, who come to the Campus for its renowned expertise and efficiency in conducting clinical trials.
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