New corona, diversion of existing drug results to be found one after another in several months
The spread of new coronavirus infection has not stopped, and the risk of medical disruption is becoming apparent all over the world. The global economy is expected to fall to the largest level since the Great Depression, and governments in various countries are busy taking action. The unprecedented situation calls for the early development of therapeutic agents and vaccines for new coronavirus infections.
According to clinical trial databases in the United States, Europe, and China, as of April 20, there are a total of 1,300 clinical trials for therapeutic agents (including Chinese medicine) for new coronavirus infections, vaccines, and testing techniques. The development of therapeutic drugs is proceeding at a rapid pace with the two wheels of diversion of existing drugs and search for new drugs. Regarding the conversion of existing drugs, it is expected that the results of multiple clinical trials will be obtained within a few months.
Remdesibir is a promising antiviral drug
So far, clinical trials for new coronavirus infectious diseases have been progressing with conversion from existing drugs that have been administered to humans, because "lemdecibir", which was developed as an anti-Ebola virus drug, and malaria. Infectious disease drug "Chloroquine", systemic lupus erythematosus drug "Hydroxychloroquine (trade name Pranikel)", anti-AIDS virus drug "lopinavir ritonavir (Kaletra)", etc. In Japan, Fujifilm Toyama Chemical's anti-influenza virus drug “Fabipyravir (Abigan)”, Teijin Pharma's bronchial asthma drug “Ciclesonide (Orvesco)”, and Nikkei's acute pancreatitis drug “Nafamostat” ) ”Is also listed as a therapeutic drug candidate.
It is lemdecivir that is likely to obtain results of clinical trials of a certain scale or more soon. Gilead Sciences Inc. is conducting two open-label, randomized controlled trials of 1600 inpatients with moderate illness and 2400 with severe inpatients. Clinical trial has already enrolled patients. In May, the company will also publish data for a total of 1000 patients enrolled in two clinical trials (breakdown unknown). Based on such data, it is considered that the approval application will be judged.
At least one patient in the U.S. hospital, who had participated in two Gilead clinical trials and received lemdesibir in more than 100 patients, had most of their symptoms improved despite being severe and could be discharged one week later. There was some media coverage. Researchers at the National Institutes of Health (NIH) and Gilead said that on April 15, when rhemdesibir was administered to rhesus monkeys infected with the novel coronavirus, lung virus levels decreased in the group treated with lemdesibir. Report the results. Therefore, the results of clinical trials are promising. However, it should be noted that none of the Gilead clinical trials were placebo-controlled.
Regarding lemdecivir, two double-blind, randomized, placebo-controlled, led by the China-Japan Friendship Clinic, targeting 308 patients with mild to moderate novel coronavirus infection and 452 patients with severe disease Tests are being conducted and results should have been known by April 2020. However, as infections in China have been suppressed, few patients meet the registration criteria and clinical trials for mild to moderate disease have been suspended. Also, clinical trials for severe cases have ended with only 237 patients enrolled, unlike the original schedule, the results obtained from these clinical trials are likely to be limited. At the same time, the difficulty of conducting clinical trials in a limited area under the circumstances that the infected area and the number of infected people change from moment to moment has been highlighted.
Chloroquine has a series of reports of side effects on the heart
On the other hand, side effects have been reported for chloroquine and hydroxychloroquine, which have undergone many clinical trials, similar to lemdecibir. On April 10, the French Agency for the Safety of Drugs and Health Products (ANSM) reported about 100 side effects, including those already known, of drug candidates administered to patients with novel coronavirus infections. Among them, it was revealed that 43 patients had cardiac side effects when combined with hydroxychloroquine alone or with antibacterial agent azithromycin. Regarding chloroquine, a Brazilian study group also found on April 16 that a long-term QT syndrome, one of the dangerous arrhythmias, was high in patients who used high-dose chloroquine in combination with the antibiotics ceftriaxone and azithromycin in a clinical trial. It was reported to be.
President Trump has shown hope for chloroquine and hydroxychloroquine, and the U.S. Food and Drug Administration (FDA) issued an emergency use permit (EUA) at the end of March 2010, but there was a concern about side effects, which caused a slight stumbling. It looks cool. Many clinical trials are ongoing in several countries and regions including Europe and the United States, and it is expected that the results will come out within a few months. It can be said that another warning was issued regarding the importance of assessing the risk of side effects.
With regard to favipiravir, which is listed as a drug candidate mainly in Japan, clinical trials have started in the US after Japan. The previous clinical trial in Japan was a single-blind, randomized, placebo-controlled trial in patients with new-type coronavirus infection who had non-serious pneumonia. The target number of patients for the time being is 96, and if there is no change in the number of patients, it will be completed by the end of June 2010. Fujifilm Toyama Chemical is expected to apply for approval in Japan depending on the results. However, it seems that Phase III clinical trials are needed in addition to the recently launched clinical trials for application for approval in the United States.
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