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On April 24, the British Financial Times reported thatAccording to a draft of the document unexpectedly released by the World Health Organization, the potentially effective new crown drug called desivir, known as “people’s hope,” failed in its first randomized clinical trial for the treatment of the new virus. the crown. The scientists and investors who gave him high hopes were disappointed.
In response to this news, Gilead released a statement saying that the WHO website prematurely released information on China’s first clinical study (currently this information has been removed), which evaluated redoxivir in severe coronavirus pneumonia. It is used in patients, but the study data is insufficient to support statistically significant conclusions.
In a statement, Gilead revealed that the results of an open-label study of severe coronavirus pneumonia in patients with new coronaviruses are expected to be released later this month.
The following calls for Gilead’s original statement:
Regarding Gilead Science’s response to research data from Ridesivir in China for patients with severe coronavirus pneumonia, the Gilead Science statement is as follows:
April 23, 2020 US time USA, Dr. Merdad Parsey, medical director of Gilead Sciences, issued the following statement on behalf of the company:
“Today, the World Health Organization (WHO) website prematurely released information about China’s first clinical study, which evaluated remdesivir of the antiviral drug in seriously ill patients with new coronavirus pneumonia. Use. This information has been deleted because the researchers did not allow the results to be published. Furthermore, we believe that the article contains an inappropriate description of the study. Due to the low enrollment rate,The study was terminated early, so its data is not sufficient to support statistically significant conclusions.For their part, the results of this study are inconclusive, although the trends in the data suggest the potential benefit of reduxil, especially among patients who received early treatment. We learned that existing data has been submitted for peer-reviewed review, and we will see more detailed information on this study in the near future.
The results of this Chinese trial, as well as the results of the sympathetic medication cohort study in critically ill patients published on April 10, provide increasingly inconclusive data for Radesivir. Redoxir is a drug not approved under investigation, and its safety and effectiveness in treating new coronavirus pneumonia are still unclear. Multiple ongoing phase III studies will provide additional data to determine the potential of redoxivir as a new treatment for coronavirus pneumonia. These studies will help to clarify the goal of the reduxil treatment, the start time and the duration of the treatment. Some of these studies have already completed all of the enrollment required for the primary analysis, and some will be completed as planned.
WeExpect to publish the results of our open study on severe coronavirus pneumonia in critically ill patients with redcivir later this month.. This is a randomized clinical trial that has completed enrollment of all patients. The study will compare treatment results and safety after 5 days or 10 days of using reducivir. We hope to obtain data from an open study of patients with moderate disease in late May. This study will compare the results of patients using Radecivir for 5 days, 10 days and receiving standard treatment. We hope that by the end of May, data will also be available from the National Institute of Allergy and Infectious Diseases (NIAID) in a double-blind, placebo-controlled study of ridxivir in patients of variable severity.
We thank Chinese researchers for their work, and our colleagues and partners around the world for their continued efforts to help us understand the potential of ridxivir as a treatment for this devastating disease. The tremendous cooperation achieved by the global health community in responding to new coronavirus pneumonia has allowed us to rapidly generate data, which has promoted our understanding of the natural history of the new coronavirus pneumonia infection and has deepened our understanding of the disease. Understand the potential role of treatment. “
