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

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 above requirements for subjects, children, adult and elderly patients of all genders can all participate in the clinical trial, however, healthy volunteers are not accepted.
• The number of the clinical trial is NCT04246242 via which all related information can be searched for. The sponsor of the clinical trial is Xiangya Hospital Central South University.

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

• The clinical trial targets patients infected with 2019-nCoV, who will be administered methylprednisolone in combination with standard care.
• The clinical trial recruits 80 subjects and is not a blind trial, namely, patients will know it when they receive methylprednisolone. The clinical trial is estimated to start on Jan. 26, 2020, preliminarily end on Apr. 25, 2020 and officially end on Dec. 25, 2020 (this end time is worth considering).
• The administration dosage is 40mg once every 12 hours for 5 consecutive days.
• Regarding the patient recruitment standards, according to the above screenshot, patients of all genders aged above 18 can all be enrolled in the clinical trial, however, healthy volunteers are not recruited.
• The number of the clinical trial is NCT04244591 via which the progress of the clinical trial can be searched for. The sponsors of the clinical trial include Peking Union Medical College Hospital ICU, Peking Union Medical College Hospital, Zhongda Hospital Southeast University, Zhongnan Hospital of Wuhan University, and Renmin Hospital of Wuhan University, etc.

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

• Intervention: Add 500ml 5% glucose injection or 0.9% sodium chloride injection to Tanreqing Injection for intravenous infusion and control the drops to be not more than 60 drops per minute, for 1-2 times per day; the dosage of Tanreqing Injection is decided by doctors according to the clinical situation and recommended to be 40ml/day or more but not more than 80ml/day.

Read More: 

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

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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