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Clinical trial analysis of 2019-nCoV therapy registered in China
Qi Zhang1, Yakun Wang1, Changsong Qi1
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
Abstract:
So far, there is a lack of effective drugs for the new coronavirus pneumonia. With more and more patients diagnosed, China has carried out more than 100 clinical studies of new coronavirus infection, including antiviral drugs, antimalarial drugs, glucocorticoids, plasma therapy, virus vaccine, and other Western drugs, while Chinese medicine research accounted for half of the studies. Most of the trials were initiated by investigators and the study period would last for 1 to 11 months. The primary endpoints included symptom improvement and virus nucleic acid turning negative, but the optimal endpoint has not been determined. Although the final results of studies will take a long time to complete, the interim research data may provide some help for the current urgent demand for drug treatment. Compared with that of during SARS period in 2003, China has the stronger capability to carry out clinical trials of new drugs in emergency period.
Insights
China is actively researching over 100 treatments for new coronavirus pneumonia, including Western and Chinese medicine. Interim data may offer urgent drug treatment options while enhancing clinical trial capabilities.
Area of Science:
- Infectious Diseases
- Pharmacology
- Clinical Trials
Background:
- Limited effective pharmaceutical interventions exist for novel coronavirus pneumonia (COVID-19).
- A significant number of clinical studies have been initiated in China to address the urgent need for treatments.
Purpose of the Study:
- To review the landscape of ongoing clinical studies for COVID-19 treatments in China.
- To assess the progress and potential interim findings from these trials.
Main Methods:
- Analysis of over 100 initiated clinical studies for COVID-19.
- Categorization of studies by treatment type (Western drugs, Chinese medicine, vaccines).
- Examination of study durations, endpoints, and investigator-initiated nature.
Main Results:
- Over 100 clinical studies are underway, with Chinese medicine research comprising half of the total.
- Studies investigate diverse treatments including antivirals, antimalarials, glucocorticoids, plasma therapy, and vaccines.
- Most trials are investigator-initiated, with durations ranging from 1 to 11 months; primary endpoints include symptom improvement and viral clearance, though optimal endpoints remain undefined.
Conclusions:
- Interim data from ongoing studies may provide valuable insights for immediate COVID-19 treatment needs.
- China has demonstrated an enhanced capacity for conducting emergency clinical trials compared to the SARS period.
- Further research and long-term results are necessary to establish definitive treatment protocols.
