"New Crown" Drug Disenchantment: Clinical Trials To Be Launched In Wuhan

There seems to be a glimmer of cure for the new outbreak of coronavirus pneumonia.

In February 2, 2020, China-Japan Friendship Hospital announced that: "the clinical research of Remdesivir in the Wuhan epidemic area led by Reed to treat 2019-nCoV new coronavirus has brought dawn to fight against the epidemic."

On the same day, the National Drug Administration's Drug Evaluation Center (CDE) publicized that this clinical trial application of Reed West Wei, a new drug for coronavirus pneumonia, has been accepted.

Previously, according to ClinicalTrials.gov PRS, the world's largest clinical trial registry, this is a randomized, double-blind, placebo-controlled, multicenter III phase clinical trial to assess the efficacy and safety of Remdesivir. The total sample size was estimated to be 270 cases. Patients with mild or moderate new crown pneumonia were expected to start in February 3rd and end in April 27th. Cao Bin, Professor of Department of respiration, China-Japan Friendship Hospital, took the lead.

The industry's confidence in Remdesivir comes from the fact that the first new coronavirus in the United States was treated with Remdesivir after exacerbation of the disease. Symptoms improved significantly the following day. "As of January 30th, the patient is still in hospital. But he is no longer fever, except cough, all symptoms have been relieved, and the degree of cough is decreasing.

On the one hand, once the clinical approval is approved, some patients in Wuhan may be able to use the drug. On the other hand, Remdesivir was not initially developed for a new coronavirus, nor has it been licensed or approved anywhere in the world. The data of one patient are not enough to prove the effectiveness of the drug.

Although the epidemic is anxious, we still need to wait for clinical data to verify its safety and effectiveness.

From Ebola to new coronavirus

In February 2nd, China-Japan Friendship Hospital related people confirmed that the clinical trial was not carried out in Beijing, but was carried out by the medical team in the epidemic area of Wuhan, according to the twenty-first Century economic report.

For the details of the clinical trial, Cao Bin, a reporter for economic reports in twenty-first Century, repeatedly contacted the lead author. In February 2nd, another member of his team, Wang Yeming, confirmed to the twenty-first Century economic report that the clinical trial had to wait for CDE approval.

Remdesivir is a nucleotides analogue prodrug that inhibits RNA dependent RNA synthase (RdRp), which was first developed against Ebola virus. Because coronavirus also has RdRp, it is presumed that it is effective against coronavirus. According to ClinicalTrials information, there is currently a phase II and III clinical trial carried out by the National Institutes of health and the Congo Ebora treatment center.

That is to say, the drug Remdesivir is still not listed and can not be used casually. It is necessary to undergo rigorous clinical trials to verify its safety and efficacy in the new coronavirus. The first patient in the United States was treated with a method called Compassionate Use.

In January 31st, the top medical journal, new England Journal of Medicine (NEJM), published a paper on the medical treatment, diagnosis, treatment and clinical manifestations of the first novel coronavirus in the US.

In January 19, 2020, a 35 year old man from Wuhan returned to the United States in an emergency department in Washington state. On the 20 day, the US Center for Disease Control and Prevention (CDC) tested its 2019-nCoV positive and sent it to the hospital for quarantine treatment. From the fifth, sixth day, the patient's condition deteriorated, and on the seventh day of admission, the doctor injected an antiviral drug that was still in development stage, that is, Remdesivir.

Then came the turning point. On the eighth day, the patient's clinical condition was improved, the oxygen uptake was stopped, and the oxygen saturation value increased to 94% to 96%. The previous bilateral lower lobe rales no longer existed. The appetite has been improved except for intermittent dry cough and runny nose.

FDA said such "sympathy use" is a clinical trial and is also very prudent. For patients who have immediate life-threatening condition or serious illness and can not be included in clinical trials to obtain research medical products, there is no comparable or satisfactory alternative therapy.

The twenty-third article of the drug administration law clearly states that "drugs that are used in clinical trials to treat diseases that are seriously life-threatening and have no effective treatment methods may be benefited by medical observation and conform to ethical principles. After examination, informed consent, they can be used in other clinical cases within the same institution."

Safety and effectiveness

For the epidemic, in January 31st, Merdad Parsey, chief medical officer of Gilead Sciences, Remdesivir provider, said: "Gilead is working closely with global health authorities to cope with the outbreak of new coronavirus (2019-nCoV) by properly and experimentally using Remdesivir of our research compound."

In his statement, Gilead stressed that Remdesivir has not yet been approved and has not yet proved its safety and effectiveness. It only weighed the risk and benefit ratio under the request of attending doctors and local regulators, and provided a few Remdesivir as an emergency treatment plan for new coronavirus patients.

An industry insider explained to the twenty-first Century economic report reporter that Remdesivir had completed the first and two phase clinical trials abroad. "To some extent, security can be guaranteed. The current clinical trials mainly need to prove that it is really effective against the new crown virus. Because the patient in the United States may be because of this drug, it may also be because of autoimmune, it may be the drugs used before it works. "

According to the newly released pneumonia diagnosis and treatment plan of new coronavirus (trial version fourth) issued by the national health and Health Committee, antiviral therapy can be treated with inhalation of interferon alpha (5 million U per adult, 5 million 2ml daily, 2 times daily), and 2 tablets of ritonavir / ritonavir (200mg/50mg each time), two times a day. Antibiotic therapy should avoid blindly or inappropriate use of antibiotics, especially the combination of broad-spectrum antibiotics. In addition, corticosteroids can be used in the short term according to the degree of dyspnea and chest imaging progress.

As of February 2nd, according to the China clinical trial registration center, there were 21 clinical trials registered as "new coronavirus", involving drugs including lpnv / ritonavir plus interferon alpha 2b, Lianhuaqingwen, Xuebijing injection, glucocorticoid, various Chinese medicines, and Tai Chi in rehabilitation.

ClinicalTrials shows that there are currently three studies for 2019-nCoV, including glucocorticoid therapy in Beijing Concord, and Research on the drug in the Xiangya Hospital of Central South University.