- At least six coronavirus patients have been enrolled in a late-stage clinical trial testing the arthritis drug Actemra as a potential coronavirus treatment.
- Mark Eisner, Genentech’s global head of immunology, infectious disease and ophthalmology clinical development, told Business Insider on Monday the study enrolled the first patients last Friday in the US and Spain.
- The study will see if the anti-inflammatory drug can help severe coronavirus patients suffering from pneumonia recover from the disease.
- The trial will enroll 330 people across the world, and Genentech is aiming to have initial results in early summer, Eisner said.
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The first patients have enrolled in a major late-stage clinical trial testing the arthritis drug Actemra as a potential coronavirus treatment, Business Insider has learned.
The study will ultimately enroll 330 people globally and produce initial results in early summer. Participants have to have severe cases of COVID-19, marked by pneumonia and requiring hospitalization.
Enrolled patients will randomly receive either an IV infusion of Actemra or a matching placebo. After a month, physicians will assess their clinical status on a seven-category scale to see if they improved or worsened. The trial will help answer if Actemra can provide a real benefit to severe COVID-19 patients, particularly after anecdotal reports of its efficacy have come out of China.
So far, at least six patients have been enrolled at trial sites in the US and Spain, Mark Eisner, Genentech’s global head of immunology, infectious disease and ophthalmology clinical development, told Business Insider on Monday. Genentech is a subsidiary of Swiss pharmaceutical company Roche.
Rather than directly fighting the virus, Actemra is an anti-inflammatory drug that may help alleviate symptoms in COVID-19 patients. In particular, some severe cases have been marked by an overactive immune response that can damage the lungs. This testing will help answer if Actemra can help these patients.
“It’s a very good hypothesis, but it’s one that needs rigorous testing in a clinical trial,” Eisner said, “so we can give clinicians, patients, their families, other stakeholders, a clear and definitive answer to what Actemra can do or not do in this disease.”
The timing of the results will depend on how quickly patients can enroll at the various sites, Eisner said. So far, Genentech is aiming for early summer.
Actemra isn’t the only drug being tested in this anti-inflammatory hypothesis. The biotech Regeneron has also launched a study of its arthritis therapy Kevzara. Both drugs have the same target, called the IL-6 cytokine.
Since both drugs are already approved in the US and in other countries around the world, doctors have broad authority to use them in non-approved indications like COVID-19.
“So many physicians around the world have been using it on their own and reporting good results,” Eisner said. “We need to get to the bottom of this and answer the question definitively as soon as possible.”