On February 2, according to the Center for Drug Evaluation (CDE) of the National Medical Products Administration, a clinical trial application for remdesivir, a drug for new coronavirus pneumonia, has been accepted.
remdesivir was previously a drug developed by Gilead for the Ebola virus. It has not been marketed globally and cannot be used casually. It must undergo rigorous clinical trials to verify its safety and effectiveness against the new coronavirus.
On January 31, Merdad Parsey, MD, Chief Medical Officer of Gilead Sciences, said: “Gilead is working closely with global health authorities to respond to the novel coronavirus (2019-nCoV) through the appropriate and experimental use of our research compound remdesivir. ).”
The agencies he mentioned include the US Food and Drug Administration (FDA), the US Centers for Disease Control (CDC), the US Department of Health and Human Services (DHHS), the Chinese Center for Disease Control and Prevention and the National Drug Administration Bureau (NMPA), National Institute of Allergy and Infectious Diseases (NIAID), as well as individual researchers and clinicians.
Gilead also stated that: Remdesivir has not been licensed or approved anywhere in the world, and has not been proven safe or effective for any use. At the request of the attending physician and with the support of local regulatory agencies (weighing the risks and benefits of providing experimental drugs without data in 2019-nCoV), Gilead provided Remdesivir for a small number of patients with new coronaviruses without any approval In the case of the treatment plan, it is used for emergency treatment.
Gilead is cooperating with Chinese health authorities to establish a randomized controlled trial to determine whether Remdesivir can be used safely and effectively to treat 2019-nCoV. We will also expedite appropriate laboratory testing of Remdesivir for 2019-nCoV.
"Although there is no antiviral data of Remdesivir against 2019-nCoV, the available data of other coronaviruses gives us hope. Remdesivir has demonstrated its in vitro and in vivo activity against the viral pathogens MERS and SARS in animal models. A coronavirus with a similar structure to 2019-nCoV. The available clinical data for emergency use of Remdesivir to treat patients with Ebola virus infection are also limited."
According to an article on the United States published online by the New England Journal of Medicine (NEJM) on January 31 The paper on the first confirmed case of the new coronavirus (2019-nCoV) detailed the patient's medical treatment, treatment and clinical manifestations. The most striking thing is that after receiving remdesivir antiviral drug treatment, this patient showed significant improvement. "As of January 30, the patient is still hospitalized, but except for the cough, other symptoms are all right, and the cough On the 7th day of admission, doctors began to use an antiviral drug, remdesivir, which is still in the development stage, to intravenously inject patients with worsening conditions. No adverse events related to infusion were observed. Vancomycin and cefepime were stopped.
turned around on the 8th day, and the patient's clinical condition improved. And stop oxygen inhalation, the oxygen saturation value increased to 94% to 96%. The previous bilateral lower Ye Luoyin no longer exists. His appetite has improved and he has no other symptoms except for intermittent dry cough and nasal discharge. As of January 30, 2020, the patient is still hospitalized. He has no fever, all symptoms except cough have alleviated, and the degree of cough is decreasing.
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