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Trial Shows Rare Disease Drug Treats Covid-19 Patients

Covid-19 illustration

(CDC.gov)

1 April 2020. Results from a clinical trial show a drug approved for a rare lymph node disease can stabilize or improve the condition of many people with severe Covid-19 complications. EUSA Pharma, the company providing the drug siltuximab, marketed under the brand name Sylvant, released interim results of the study today.

As the worldwide burgeoning Covid-19 pandemic continues, patients with severe forms of the disease can develop acute respiratory distress syndrome, or ARDS, a life-threatening complication where fluid leaks into the lungs, The fluid build-up makes breathing difficult and adequate oxygen does not get to the body. ARDS is often triggered by injury to the lungs, and in the case of Covid-19 infections, from inflammation reacting to the SARS-CoV-2 virus responsible for the infections.

EUSA Pharma, in Hemel Hempstead, U.K., develops therapies for cancer and rare diseases, and offers siltuximab, a synthetic antibody approved in the U.S. and Europe to treat multicentric Castleman disease, a rare disorder of the lymph nodes with symptoms similar to lymphoma. Siltuximab works by blocking actions of interleukin-6, a cytokine or signaling protein in the immune system associated with many types of inflammation. Elevated levels of interleukin-6, or IL-6, are often found in people with severe Covid-19 infections, including those with ARDS.

The observational clinical trial is enrolling 50 patients with severe Covid-19 infections at Papa Giovanni XXIII hospital in Bergamo, Italy, a city in the Lombardy region with among the highest concentration of Covid-19 infections. The study team reports on the first 21 patients receiving siltuximab infusions. Of the 21 participants, 16 received a single dose, while five patients also received a second dose, two to three days later as requested by their physicians. Participants are assigned to receive siltuximab either in intensive care units or in non-intensive care settings, and are monitored for seven days. The trial has no placebo group.

The results show in nine of the 21 participants, or 43 percent, their condition stabilized, meaning no further deterioration, and another seven participants or 33 percent show improvement in their condition. Thus in three-quarters or 76 percent of participants, their condition stopped deteriorating or improved after treatment. Three patients saw their condition get worse, one patient suffered disruption of blood flow to the brain, and another patient died. In addition, all participants able to provide readings — 16 of 21 — of c-reactive protein, made in the liver and produced in response to inflammation, show reductions in the level of this protein seven days after treatment.

Alessandro Rambaldi, director of the hematology unit at Papa Giovanni XXIII hospital that sponsors the trial, says in a EUSA Pharma statement, “Whilst we are yet to identify and analyze the control group of patients, these initial data in siltuximab-treated patients provide vital information to guide decisions regarding appropriate use of siltuximab in both the real-world and new COVID-19 studies as we continue to investigate the role IL-6 blockade can play.”

The sponsors say they deposited the manuscript with the medRxiv pre-print service and plan to submit the findings to a medical journal.

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