On March 19 (BJT), the New England Journal of Medicine (NEJM), the world's most influential medical academic journal, published online the result of a clinical trial conducted by a Chinese team on the use of lopinavir/ritonavir to treat patients with severe COVID-19.

Since the outbreak of COVID-19, this is the first clinical trial result published by the top medical journals in the world for the treatment of COVID-19, also one of the few clinical trial results of drugs published during the outbreak of new infectious diseases including SARS in the past 20 years. The NEJM editorial published in the same period praised the clinical trial as a heroic move.

The lead authors of this paper are mainly from China-Japan Friendship Hospital, National Clinical Research Center for Respiratory Disease and Wuhan Jinyintan Hospital. Teddy Lab, a subsidiary of DIAN Diagnostics, participated in such great clinical research as a central lab and completed the critical quantitative detection of viral nucleic acid with high efficiency and quality, which provided strong scientific support for the research result and was highly praised by researchers.

Within an extremely limited time and under difficult lab conditions, Teddy Lab, together with Wuhan DIAN, established quickly a real-time quantitative RT-PCR method for viral nucleic acid detection in line with the methodological standards for clinical trials, and completed the validation of the method strictly following the guidelines of CAP, CLSI and MIQE, with excellent performance in the precision, sensitivity, accuracy and specificity of the methodology. Moreover, in the process of the research, Teddy Lab further standardized the operation process and quality control standards for sample testing, which ensured the accuracy and credibility of testing results and provided strong support for the development of the test and the analysis of the testing results.

“It is quite remarkable how quickly you were able to stand up this study- a little over a week after the virus was identified.”As the editor of NEJM spoke highly of Teddy’s team, “It is quite remarkable how quickly you were able to stand up this study- a little over a week after the virus was identified.”

The trial named “a randamized, open and controlled study on the efficacy and safety of lopinavir/ritonavir in treatment of hospitalized patients with COVID-19” (ChiCTR2000029308) was started in January this year, for the purpose of which, it was originally intended to recruit 160 patients. But finally, 199 patients with SARS-CoV-2 as confirmed in labs were recruited, of which 99 were enrolled in the lopinavir / ritonavir group and the rest 100 were enrolled in the standard therapy group.

Despite the clinically beneficiary trend as founded in the trial, due to the limitation of time and sample size, overall it was concluded as follows: the current study concludes that in comparison with standard therapy, the therapy with lopinavir / ritonavir fails to benefit adult inpatient with severe COVID-19 significantly in clinic.

“Covid-19 — The Search for Effective Therapy”, a NEJM editorial published at the same time as the paper, said that “ although one of the groups in highest risks, the health care workers in Hubei Province provided care for patients during this massive epidemic. As we saw from the Ebola in 2014, in face of epidemics, it’s extremely difficult to obtain high-quality clinical trial data to guide patient care, and the feasibility of randomized design was also challenged. However, the clinical study showed that it’s possible to quickly start a randomized clinical trial with high-quality design even under the conditions as severe as those in Wuhan, and the clinical study would play a significant role in the design and development of new trials. With the worldwide continuation of COVID-19, such clinical trials would produce material influence in clinical care for patients with COVID-19, whether the results are positive or not.

This study provided valuable scientific data and reference for further search for effective therapy of COVID-19 in China and even around the world. Also, Teddy Lab established standards and accumulated experience for laboratory testing methods of relevant clinical trials initiated under special conditions.

In the future, DIAN Diagnostics and its member companies including Teddy Lab will continue to provide support for global scientific tests against COVID-19, in order to win the global war against the “epidemic” as quickly as possible.