Research on the antiviral drug Redcivir for the treatment of new coronary pneumonia continues in China. According to the official website of the China Biotechnology Development Center, the “Chinese-type genetic resources international cooperation clinical trial filing public notice” released on May 8, including Gilead Science applied for a three-phase study, comparing the safety and antiviral activity of Redsiewe and standard nursing treatment for patients with moderate new coronary pneumonia.
According to the public announcement, the study was called “A Comparative Assessment of Redsive GS-5734 ™ and Standard Nursing Therapy for the Treatment of Moderate COVID-19 Research Participants in The Randomization Phase 3 Study”, and that the medical institution (Group Leader Unit) is the First Hospital affiliated with Guangzhou Medical University, and the contract research organization is Beijing Famasutik Consulting Co., Ltd. for filing in May 2020.
In response, Gilead Sciences responded to the news agency by saying that Gilead had announced at the end of February that it was conducting a randomized, open-label, multi-centerED SIMPLE Phase III clinical trial for Redsey. The filing is part of a “Comparative Assessment of Redsive GS-5734 and Standard Care Therapy For The Randomization of Safety and Antiviral Activity in Patients of Moderate COVID-19” in China, which is mentioned in the filing.
The First Affiliated Hospital of Guangzhou Medical University said it would not be convenient to accept the interview.
Gilead previously said that several ongoing Phase III clinical trials are evaluating the safety and efficacy of Redcywe’s treatment of the new coronavirus pneumonia. Among them, the randomized, open-label, multi-center SIMPLE Phase III clinical trial symmered into two sessions of Redcywe.
The first SIMPLE study is evaluating the safety and effectiveness of the 5-day treatment and 10-day treatment for patients with severe hospitalization for new coronavirus pneumonia. During the initial phase, 397 patients were randomly divided into two groups at 1:1 and, in addition to standard treatment, received 200 mg of ridsibee on the first day of intravenous injection, followed by 100 mg of ridsievir treatment daily until the fifth or tenth day. The study, which recently added to the expansion phase, will recruit an additional 5,600 patients, including those who receive mechanical ventilation. The study is being conducted at 180 test sites around the world, covering the United States, China, France, Germany, Italy, Japan, South Korea, the Netherlands, Singapore, Spain, Sweden, Switzerland and the United Kingdom.
The second SIMPLE trial is evaluating the safety and efficacy of the 5th and 10th course of intravenous administration of standard therapies for patients with moderately new coronary pneumonia. The results of the first 600 patients in the study are expected by the end of May.
On April 29, Gilead announced the top line results of an open-label SIMPLE Phase III clinical trial that evaluated the effectiveness of severe lycinal patients with new coronavirus pneumonia who were given the antiviral drug Redcivir for 5 and 10 days, respectively. Studies have shown that patients who received a 5-day rhimaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa No new Redsiewe safety signals were found in either treatment group.