PharmaSources/zhulikou431February 14, 2020
Tag: Clinical trials , pneumonia , 2019-nCov , Novel Coronavirus Pneumonia
The novel coronavirus pneumonia incident that started to occur in Wuhan City, Hubei Province from Dec. 2019 has produced continuous impacts on the Chinese people.
The World Health Organization (WHO) officially announced the current novel coronavirus epidemic as a "public health emergency of international concern" (PHEIC) on Jan. 30, 2020. According to the official definition of the WHO, this means that this epidemic starting in Wuhan, China has been a threat to the public health security of countries in the world and requires the joint responses of the international community.
The National Medical Products Administration of China (NMPA) and related provincial administrations have taken active response measures at the beginning of the epidemic confirmation and strict control: nearly 10 detection kits of many enterprises have so far been approved for clinical diagnosis and detection.
However, there are still no clear conclusions as to the effective drugs that people are more concerned about.
The WHO’s replies to those key issues in the related guideline are as follows:
Is there a vaccine for a novel coronavirus?
Reply: When a disease is new, there is no vaccine until one is developed. It can take a number of years for a new vaccine to be developed.
Is there a treatment for a novel coronavirus?
Reply: There is no specific treatment for disease caused by a novel coronavirus. However, many of the symptoms can be treated, therefore, treatment can be based on the patient’s clinical condition. Moreover, supportive care for infected persons can be highly effective.
To actively respond to the current predicament of lacking effective drugs, both Chinese and overseas pharmaceutical enterprises are actively screening and assessing the drugs marketed or in development, to seek effective drugs against this virus pneumonia challenge.
The latest information on the clinical trials of related drugs is collected and organized herein, in the hope of providing some help to people and pharmaceutical practitioners.
Description: The order in which the following drugs are introduced only represents the writing order in this article instead of the priorities of my recommendation of the drug efficacy.
Part I: Arbidol
1.1-Purpose of study
The purpose is to determine the effect and safety of arbidol in patients with 2019 novel coronavirus (2019-nCoV). According to the principles of randomized, double-blind, controlled clinical trials, patients with 2019-nCoV are divided into three groups, with the first group administered 200mg arbidol, tid (3 times a day), the second group administered 400mg arbidol, tid, and the third group not administered arbidol, for separately 5 days. And the three groups of patients receive other antiviral and comprehensive treatments that are the same. Then, researchers will compare the first result: 28-day mortality, and the second result: ICU length of stay, duration of mechanical ventilation, hospitalization expenses, antibiotic use cost, SOFA score, CURB-65 score, APACHE score, and other clinical indicators.
1.2-Clinical trial information points
The clinical trial indication of arbidol is 2019-nCoV, with patients divided into three groups. The trial belongs to a post-marketing phase IV clinical trial as arbidol has been marketed for years.
The clinical trial needs to recruit 500 subjects. According to the above screenshot, the research topic is a randomized, multicenter, controlled clinical trial to evaluate arbidol’s effects against 2019-nCoV infection. The trial is estimated to start on Jan. 25, 2020, preliminarily end on Apr. 30, 2020 and eventually end on May 30, 2020.
According to the announcement of Jiangsu Wuzhong on Jan. 21, 2020, Arbidol Hydrochloride Tablets is one of the products produced and marketed by the company’s wholly-owned subsidiary Jiangsu Wuzhong Pharmaceutical Group. As a drug for preventing and treating influenza, the product blocks virus replication by inhibiting the fusion between the influenza viruses’ panniculus adiposus and host cells. However, there is no evidence of the product’s effect against the "novel coronavirus".
The above announcement of Wuzhong is prudent and objective because before the clinical trial comes to definitive conclusions, there is indeed no evidence that arbidol is effective for patients infected with 2019-nCoV.
Part II: Methylprednisolone
2.1-Purpose of study
It is a multicenter, randomized, controlled clinical study where researchers will assess the effect and safety of glucocorticoid and standard care received by patients infected with 2019-nCoV.
2.2-Clinical trial information points
Part III: Recombinase Aided Amplification (RAA) Assay
3.1-Purpose of study
The purpose is to develop a simple, fast and portable recombinase aided amplification (RAA) assay for 2019-nCov.
3.2-Clinical trial information points
The purpose of the clinical trial is not to study a therapeutic drug but to study an assay for clinical samples, thus, it will not be detailed here. The number of the clinical trial is NCT04245631 via which interested readers can search for the related information at any time.
Part IV: Lianhua Qingwen Capsules/Granules
4.1-Purpose of study
The purpose is to 1: evaluate the clinical effect of Lianhua Qingwen Capsules/Granules in treating pneumonia infected by the novel coronavirus; 2: evaluate the safety of Lianhua Qingwen Capsules/Granules in treating pneumonia infected by the novel coronavirus.
4.2-Clinical trial information points
Description: The registration No. of the clinical trial is ChiCTR2000029434. Two clinical trials involving Lianhua Qingwen Capsules can be searched on the website of the Chinese Clinical Trial Registry. The No. of the other one is ChiCTR2000029433. Readers can search for the related information via the numbers.
Part V: Tanreqing Injection
5.1-Purpose of study
The purpose is to observe the clinical effect and safety of the large-dose TCM injection in treating pneumonia infected by the novel coronavirus, to form a TCM therapeutic regimen with definite efficacy and convenient for promotion.
5.2-Clinical trial information points
Read More:
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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