Top Medical Journal “The Lancet” Publishes Results of First Randomized Controlled Clinical Trial of Remdesivir, which was fully supported by Tigermed
April 30, 2020
April 29, 2020, the international medical journal The Lancet published online the results of the world’s first randomized, double-blind, placebo-controlled, multicenter clinical trial of Remdesivir, an antiviral drug for coronavirus disease 2019 (COVID-19) in Wuhan, China.
The study was conducted by investigators from the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Institute of Pharmaceutical Research of the Chinese Academy of Medical Sciences, Jin Yin Tan Hospital of Wuhan, and other related units. As the industry-leading clinical CRO in China, Tigermed volunteered to provide services and support during the complete study to aid in the fight against COVID-19.
The randomized, double-blind, placebo-controlled, multicenter clinical trial of a new drug, is recognized as the highest level of clinical research evidence. Professor John Norrie of the University of Edinburgh, UK (not involved in the study), commented on this study in the same issue of The Lancet: “The study was well-designed — a double-blind, placebo-controlled, multicenter, randomized trial—and well-conducted, with high protocol adherence and no loss to follow up.”
On February 5, 2020, a clinical study of Remdesivir in patients with coronavirus disease was launched in Wuhan. From February 6 to March 12, 2020, a total of 237 adult hospitalized patients with laboratory-confirmed severe COVID-19 were enrolled.
During the study, Tigermed was actively involved and quickly set up a project team under extremely tight deadlines and difficult conditions. A group of professionals from Tigermed and its subsidiaries all over the country, came forward and volunteered to join this project, working with local teams in Hubei and Wuhan and devote to this research to ensure quality and efficiency.
Due to the epidemic being controlled and the steep decline in cases, the study is unable to recruit enough patients after enrolling 237 cases. According to the pre-determined terms of “no new enrollment in case of controlled or discontinued outbreaks and discontinuation opinion by the Independent Data Monitoring Committee (IDMC), the study was discontinued early. Conclusion is that, the study was completed in strict compliance with the protocol and Remdesivir did not significantly improve clinical symptoms in patients with severe coronavirus disease. Effectiveness remains to be determined in expanding case studies.
Based on conditions of this study and the conclusions reached, the investigators believe that more definitive therapeutic effects might be observed in the future by considering earlier dosing, dose increases, or observation after extended treatment based on nucleic acid results.
Presently, several clinical studies related to Remdesivir are in progress, and comprehensive analysis can be conducted in the future to explore and clarify the indications and effects of its application.
Professor Bin Cao, Head of the Remdesivir Clinical Trial Program and Vice President of China-Japan Friendship Hospital, said: “We sincerely appreciate the support from the Ministry of Science and Technology, State Health Commission, NMPA, and all other departments, as well as the active participation and help of various research centers and experts. Meanwhile, we’d like to thank Tigermed for their professional and high-quality services and support throughout this research project, and for working with us to complete such a crucial and urgent clinical study. Although this trial found no significant benefit from Remdesivir compared to placebo, it provides valuable scientific data and reference for further research on effective COVID-19 treatment all over the world.”
While the COVID-19 crisis endures, Tigermed looks forward to the results of new clinical studies in multiple regions and will continue to support global scientific research and clinical trials to aid in the fight and help save lives.
Hangzhou Tigermed Consulting Co., Ltd（stock code: 300347）is a leading Contract Research Organization (CRO) in China dedicated to provide full comprehensive services and solutions for clinical research and development. Since inception in 2004, Tigermed has always embraced state-of-the-art technologies and has engaged in partnerships to accelerate medical product development with costs efficiency and high quality.
Headquartered in Hangzhou, Tigermed operates 46 subsidiaries and 123 offices across China, and 13 overseas offices in US, Switzerland, Korea, Australia, Japan, Malaysia, Singapore , India, Canada and Romania with over 5,000 full time employees. Tigermed has serviced more than 650 local and global clients in the conduct of over 2,000 clinical trials. Tigermed is recognized as “The Innovative CRO” in China, owning to our involvement of over 310 innovative drug projects.