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PharmaSources/Zhulikou431February 14, 2020
Tag: Clinical Trials , 2019-nCov , Novel Coronavirus Pneumonia
Part VI: Three antiviral regimens
6.1-Purpose of study
Evaluate the effect and safety of three antiviral regimens in treating pneumonia patients infected with the common or novel coronavirus.
6.2-Clinical trial information points
Part VII: Glucocorticoid (methylprednisolone)
7.1-Purpose of study
Evaluate the effect and safety of the glucocorticoid in treating novel coronavirus infection and explore the optimal treatment mode.
7.2-Clinical trial information points
Part VIII: Xuebijing Injection
8.1-Purpose of study
Evaluate the improvement of the pneumonia severity index (PSI) by Xuebijing and the influence thereof on the 28-day prognosis.
8.2-Clinical trial information points
Part IX: Combination therapy of lopinavir/ritonavir and interferon α2b
9.1-Purpose of study
Evaluate the effect and safety of the combination therapy of lopinavir/ritonavir and interferon α2b in treating adult inpatients infected with novel coronavirus compared to the standard treatment.
9.2-Clinical trial information points
Part X: Remdesivir
According to the news of the China-Japan Friendship Hospital on the noon of Feb. 2, 2020, the China-Japan Friendship Hospital will lead the clinical study of treating 2019-nCoV with remdesivir in 2019-nCoV-affected Wuhan.
10.1-Purpose of study
The purpose of study according to the screenshot on the internet is a randomized, double-blind, controlled, multicenter clinical trial to evaluate the effect and safety of remdesivir in patients infected with 2019-nCoV.
10.2-Clinical trial information points
The following screenshot taken from the database of the NMPA shows the registration information of remdesivir. According to it, remdesivir is administered via injection.
Acceptance No. | Pharmaceutical product name | Pharmaceutical product type | Application type | Registration class | Enterprise name | Acceptance date |
JXHL2000019 | Remdesivir for Injection | Chemical drug | Imported drug | 1 | Gilead Sciences Inc., Gilead Sciences, Inc., Institute of Materia Medica Chinese Academy of Medical Sciences & Peking Union Medical College | Feb. 2, 2020 |
Additional remarks: 17 pieces of related information can be searched on the website of the Chinese Clinical Trial Registry (CHICTR) by searching keywords such as coronavirus. In addition to the above information relating to the specific drugs, there is much more information on clinical therapeutic regimens. Interested readers can search for and read such information themselves.
P.S.
According to the announcement of Staidson (300204) on the evening of Feb. 2, 2020, the company and its wholly-owned subsidiary Beijing Defengrui Biological Technology Co., Ltd. (hereinafter referred to as "Defengrui") have applied to the NMPA for the clinical trial of treating the related diseases caused by coronavirus with BDB-001 Injection.
Specifically, the name of the pharmaceutical product in this application is BDB-001 Injection, and the proposed indication is the complement system that can be specifically overactivated by the coronavirus. The product can inhibit the inflammatory responses caused by complement system activation as a result of factors such as viruses, treat persons infected by the coronavirus, etc., prevent pneumonia, prevent pneumonia from worsening and reduce the incidence of acute respiratory distress syndrome.
Conclusion
The collection time of the information summarized above is Feb. 2, 2020, which will change with the progress of scientific research. Interested readers can search for the latest information themselves. Moreover, there is currently no drug proven to be effective against the novel coronavirus pneumonia. Before the above clinical trials end and come to definite conclusions, isolation and infection prevention are still necessary means.
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References
1-Clinical Trials website information
2-CDE website information
3-NMPA website information
4-Gilead website information
5-Wuzhong Pharmaceutical website information
6-Shijiazhuang Yiling Pharmaceutical website information
7-Union Clinical Medication Quick Query Manual (2015 First Edition)
8-Chinese Clinical Trial Registry
9-Chinese Pharmacopoeia 2015 Edition Volume III
10-China-Japan Friendship Hospital website
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