A Summary and Interpretation of the Progress of Clinical Trials Relating to the Novel Coronavirus Pneumonia (2)

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

• The clinical trial recruits 120 patients in total and divides them into three groups, with 40 in each group. The first group (Group A) is administered ribavirin+interferon α1b; the second group (Group B) is administered lopinavir/ritonavir+interferon α1b; the third group (Group C) is administered ribavirin+lopinavir/ritonavir+interferon α1b.

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

• Intervention group dosing regimen: lopinavir/ritonavir tablets (with each tablet containing 200mg lopinavir and 50mg ritonavir), twice daily, 2 tablets per time; α-interferon aerosol inhalation (5 million U per time, added with 2ml sterile water for injection), twice daily; methylprednisolone intravenous injection, 1~2mg/kg·d, for 5 days;

• Control group dosing regimen: lopinavir/ritonavir tablets (with each tablet containing 200mg lopinavir and 50mg ritonavir), twice daily, 2 tablets per time; α-interferon aerosol inhalation (5 million U per time, added with 2ml sterile water for injection), twice daily, without using glucocorticoid.

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

• According to the registration information, the trial has two trial groups, with one administered Xuebijing Injection and the other one receiving the conventional treatment.

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

• According to the clinical trial registration information, the trial group will be administered lopinavir/ritonavir tablets (each containing 200mg lopinavir and 50mg ritonavir), twice daily, and 2 tablets per time, and also interferon α2b, while the control group will receive the conventional treatment.

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.

• According to the above information, the clinical trial starts on Feb. 3, 2020 and is estimated to end on Apr. 27, 2020.

• The sponsor of the clinical trial is Capital Medical University, and the lead researcher is Professor Cao Bin of the China-Japan Friendship Hospital.

• 270 subjects are recruited and randomized into groups.

• The subjects of the clinical trial are divided into 2 groups, with one receiving remdesivir treatment and the other one receiving placebo treatment.

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.

Read More: 

A Summary and Interpretation of the Progress of Clinical Trials Relating to the Novel Coronavirus Pneumonia (1)

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

About the Author:

zhulikou431

Zhulikou431, as a senior engineer, PDA member, ISPE member, ECA member, PQRI member, senior aseptic GMP expert, has deep knowledge in aseptic process development and verification, drug development and registration, CTD document writing and review, regulatory audit, international certification, international registration , quality system construction and maintenance, as well as sterile inspection, environmental monitoring and other fields. In recent years, he has focused on the analysis of trends in the macro pharmaceutical field and the risk management of pharmaceutical enterprise mergers and acquisitions projects.

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