New Crown Pneumonia Treatment Drug Global Exploration Carried Out, FDA Issued Emergency Use Authorization Such As Chloroquine.

With the outbreak and spread of the new crown pneumonia (COVID-19) epidemic worldwide, the exploration, discussion and regulatory actions against new crown virus (SARS-CoV-2) drugs have become a common topic of global researchers.

On March 28th, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for new crown pneumonia drugs: chloroquine phosphate and hydroxychloroquine sulfate for COVID-19. Chloroquine phosphate is also included in the diagnosis and treatment plan of new coronavirus pneumonia issued by the Wei Jian Committee of China.

In the evening of March 28th, the respiratory medicine branch of the Chinese Medical Association and the Chinese medical association respiratory medicine branch were invited by Professor Anita Simonds, chairman elect of the European Respiratory Association (ERS). Professor Cao Bin, vice president of China-Japan Friendship Hospital, introduced the experience of China's prevention and control to European and global respiratory specialists. It is reported that more than 1000 European peers live online. Cao Bin presided over a number of clinical trials of new crown virus drugs in the front line of "epidemic prevention" in Wuhan, including the "hope of the people", Remdesivir, and another trial of COVID-19, an imported drug, to treat severe COVID-19 adult inpatients.

On the night of March 30th and 31st Beijing, a number of Chinese experts including academician Wang Chen and Cao Bin of the Chinese Academy of Engineering shared the most first-hand experience to their counterparts in the United States, including the construction of shelter hospitals, the exploration of antiviral drugs and the management of critical diseases.

Since the beginning of the epidemic, China has selected a batch of drugs for clinical use with the idea of "old drugs being used in a new way". At the joint defense joint control conference of the State Council in March 17th, Zhang Xinmin, director of the Biotechnology Center of the Ministry of science and technology, introduced the research progress in the treatment of different types of patients, including chloroquine phosphate, valaspirin and Chinese medicine, convalescent plasma, monumab, stem cells and artificial liver. These drugs are also being tested in the US, South Korea, Italy, Spain and France.

From Reed's to the chloroquine phosphate

In accordance with the above FDA announcement, the approved emergency use authorization allows the donation of hydroxychloroquine sulfate and chloroquine phosphate to the "national strategic repository" (SNS). These drugs will be distributed to the states by SNS, and should be administered to adolescents and adults hospitalized for COVID-19 when the clinical trials are unavailable or infeasible. EUA asked for information on the important information about the use of chloroquine phosphate and hydroxychloroquine in the treatment of COVID-19, including known risks and drug interactions.

Unlike previous Compassionate Use, which is not listed, Reed, according to the 564th federal food, drug and Cosmetic Act (FD & C Act), emergency use authorization (Emergency Use) Authorization, EUA) is FDA's unauthorized use of unapproved medical products or approved products in public health emergencies, with no alternative method for diagnosis, treatment or prevention of serious or life-threatening diseases or conditions.

Hydroxychloroquine sulfate and chloroquine phosphate are all antimalarial drugs. They have been listed for many years, and their drug storage and accessibility are good. Hydroxychloroquine sulfate was approved in FDA for malaria and adult autoimmune diseases, including systemic lupus erythematosus and rheumatoid arthritis.

Chloroquine phosphate has previously shown a good anti new-type coronavirus activity in China. However, drug adjustment is also dynamic, such as chloroquine phosphate has obvious adverse reactions, the diagnosis and treatment plan has carried out dosage and contraindication (such as those with heart disease disabled).

In response to the "call" of FDA, Sandoz, the generic drug Department of Novartis, donated 30 million doses of hydroxychloroquine tablets to the US Department of health and public service (HHS) for clinical research. The shipment is part of Novartis's previously announced 130 million slice of global donations and will be distributed in various clinical trials and stakeholders around the world.

For the current treatment plan adopted by the United States, FDA said, "there is no FDA approved treatment for COVID-19 or other coronaviruses." FDA also launched a clinical trial on Reed Sewell. In March 24, 2020, FDA released health care providers information on rehabilitated plasma for patients with severe COVID-19.

Like Chinese researchers, medical institutions and doctors in the United States have tried different ways. According to ClinicalTrials.gov, Massachusetts General Hospital has conducted a study on the prevention of COVID-19 by inhaling carbon monoxide.

Global "synchronous" epidemic

So far, clinical trials of new crown pneumonia have been carried out in China. As of March 30th, in twenty-first Century, the economic report reporters found 537 registered test items related to COVID-19 at the China clinical trial registration center. Experts from the industry, scholars and WHO have called for researchers to be self disciplined and prudent to carry out the new crown clinical practice, so as to avoid invalid clinical occupancy resources and transfer risks to patients.

In February 28th, the world's largest clinical trial registry clinicaltrials.gov registered 56 tests on 2019-nCoV. A month later, in March 30th, the COVID-19 related tests had risen to 202. These studies on new crown pneumonia all over the world, including the drug test of tzumab and Emapalumab monoclonal antibody carried out in Italy; in the United States, Sarilumab clinical trials, Reed, and hydroxychloroquine co developed by Senofi and regenerated yuan were carried out in the United States; in Spain, there was a test of natural honey in Cairo, Egypt.

In March 19th, Roche announced its collaboration with FDA to launch the III phase Actemra/RoActemra clinical trial for COVID-19 critically ill patients, and is expected to begin in early April. Roche said that so far, several independent clinical trials have explored the efficacy and safety of turozumab in the treatment of COVID-19, and the other is that it has been included in the National Health Council's diagnosis and treatment plan. It is the first approved IL-6 receptor biological agent for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults.

Another concern is the anti IL-6 receptor biologics, which are jointly developed by Sanofi and regenerated KEVZARA (SARILUMAB). In March 16th, they announced that they began to recruit clinical trial patients in the United States. Based on a study still coming from China. In addition, in March 18th, clinical research on Siltuximab monoclonal antibody was also carried out in Italy. EUSA Pharma announced that the study was sponsored by Papa Giovanni XXIII hospital.

Up to now, Reed Wei Wei has not yet been "blinded", and the world is eagerly looking forward to the results of the trial in Wuhan. Another experiment led by Cao Bin is not satisfactory. Beijing time March 19th, the new England Journal of Medicine (NEJM) published online clinical trials of the Chinese team on the use of ritonavir / ritonavir in the treatment of severe new crown virus disease (COVID-19). This is the first clinical trial published by the world's top medical journal for the treatment of COVID-19 since the outbreak of the new crown virus outbreak. It is also the result of a handful of clinical trials published during the past 20 years of new infectious diseases including SARS. The main authors are from China-Japan Friendship Hospital, national respiratory disease clinical research center and Wuhan Jin Yin Tan Hospital. In January 18th, when the new crown virus was identified and sequenced for about a week, the first patient was enrolled in the trial. The results showed that, compared with conventional treatment, we did not observe the efficacy of ralenavir / ritonavir in severe COVID-19 adult inpatients.

But the NEJM editorial issued in the same period commended the trial as "heroic." Although ritonavir / ritonavir does not seem to have a high effect on patients with COVID-19, this study still has many important values. Because the dangerous coronavirus epidemic is still continuing, it is very important for clinical diagnosis and treatment.