A small group of patients hospitalized with severe complications from COVID-19 and treated with the experimental antiviral drug Remedesivir were diagnosed according to an analysis co-authored by Jonathan Grein, MD, director of hospital epidemiology at Cedars-Sinai Clinical improvement was observed in 68% of patients treated. Experimental therapy was administered to patients as part of a compassionate use program that provides providers with access to treatments not yet approved by the Food and Drug Administration when a patient is in is in a life-threatening condition and no other options are available. The analysis, published online today by the New England Journal of Medicine, evaluated data from 53 patients in the United States, Europe, Canada, and Japan who survived until the 7th
March received at least one dose of remedesivir.
The efforts were led by Gilead Sciences, the pharmaceutical company that manufactures the experimental drug.
The study shows: “There is currently no proven treatment for COVID-19.
We cannot draw definitive conclusions from this data, but observations from this group of hospitalized patients receiving Remedesivir are hopeful, ”said Grein, who also leads the Cedars-Sinai Special Pathogens Response Team.
We look forward to the results of controlled clinical trials to potentially validate these results. ”Cedars-Sinai continues to explore remedesivir as a treatment option for patients as part of a large international randomized controlled trial sponsored by the NIH.
The compassionate use programs are less rigorous than a randomized controlled trial comparing patients receiving experimental treatment with those receiving standard treatment.
However, during the COVID-19 pandemic, compassionate use data can help scientists understand potential risks and can …
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