Researchers are narrowing the focus of an ongoing trial of a potential coronavirus treatment after reviewing preliminary results.
Going forward, the study will enroll only some of the sickest COVID-19 patients: those on ventilators, high-flow oxygen therapy, or in the ICU.
The trial is testing an anti-inflammatory arthritis drug called Kevzara, developed and sold by the New York biotech Regeneron and French pharma Sanofi.
Researchers think the treatment may work in COVID-19 by alleviating symptoms of the disease, rather than directly fighting the virus. Critically ill patients often have an overactive immune response, which this medicine could help calm down.
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A potential coronavirus treatment just suffered a setback, as researchers narrowed a clinical trial of the drug Kevzara after an early review of how the treatment was working.
The early look at study data led researchers to change the study to exclusively focus on critically ill coronavirus patients. The drugmakers Regeneron and Sanofi are testing Kevzara, an arthritis drug, against COVID-19, the disease caused by the novel coronavirus.
The companies said Monday they they’ll stop enrolling patients with “severe” illness and only focus on “critical” patients. More data is expected from that group of patients by June.
Critical patients are either on ventilators, high-flow oxygen therapy, or in the ICU. Severe patients require oxygen supplementation but don’t require mechanical ventilation or high-flow oxygen.
The first part of this study was testing low and high doses of Kevzara. Only the high dose will be used going forward.
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These are some of the first high-quality study results in COVID-19. Kevzara is being tested in a trial designed to rigorously look for a benefit: Patients are randomly assigned to either the drug or a placebo.
In March, an antiviral drug used to treat HIV failed to show a benefit in fighting the coronavirus in a trial that compared it to a placebo.
The Kevzara results show the need for “controlled data in adequately-sized trials,” George Yancopoulos, Regeneron’s chief scientific officer, said in a statement.
The companies noted that the severe group of patients fared much better than expected, regardless of whether they were receiving Kevzara or a placebo. They noted that 80% of severe patients were discharged, 10% died and 10% are still hospitalized.
Read more: There are more than 70 potential coronavirus vaccines in the works. Here are the top efforts to watch, including the 16 vaccines set to be tested in people this year.
The medical theory behind using Kevzara in COVID-19 is that it can ease the disease symptoms that the sickest COVID-19 patients suffer. This group of patients often has an overactive immune response that can damage their bodies. Kevzara is an anti-inflammatory drug that could calm that immune response.
Researchers are also testing a similar treatment from Swiss drugmaker Roche, called Actemra. Both drugs have the same target, called the IL-6 cytokine. Roche’s study began enrolling patients earlier this month, with results expected in early summer.
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