Starting in March this year, these randomized, open, multicenter studies will be conducted in medical institutions mainly in Asia and other countries with more confirmed cases in the world, involving about 1000 patients. This study will evaluate the efficacy of ridcivir at two times of intravenous administration. The primary end point of both studies was clinical improvement.
In one study, about 400 patients with severe clinical manifestations of covid-19 were randomly assigned to receive 5 or 10 days of ridcivir treatment in a 1:1 ratio. On the first day, 200 mg of ridcivir was given intravenously, then 100 mg of ridcivir was given daily until the 5th or 10th day, in addition to standard medical care. The main purpose of this study was to evaluate the effect of radcivir by measuring the normalization of fever and oxygen saturation (T < 36.6c armpit, < 37.2c mouth, < 37.8C rectum; and sp02 > 94%, for at least 24 hours until the 14th day).
The second study will randomly select about 600 patients with moderate clinical symptoms and receive only 5 or 10 days of Reeds or standard treatment. Approximately 600 participants will also be randomly assigned on a 1:1 scale to receive 200 mg of ridcivir on the first day, and then 100 mg of ridcivir beyond the daily treatment criteria until day 5 or day 10. The main purpose of this study is to measure the proportion of patients in each group discharged from hospital on the 14th day, and the difference between standard treatment and radcivir treatment.
Prior to the novel coronavirus pneumonia, the FDA quickly examined and accepted gilids application for new crown pneumonia Research (IND).
The new clinical research also includes two clinical trials that have been led by the China Japan Friendship Hospital in Hubei, China, and recently led by the National Institute of allergy and infectious diseases (NIAID) in the United States. According to previous CNBC reports, the trial, jointly led by the University of Nebraska Medical Center and the National Institute of allergy and infectious diseases, will be conducted in as many as 50 locations around the world. Gilead has donated drugs to the research institutions and provided scientific support for these studies, and the results of Chinas research are expected to be published in April.
Novel coronavirus pneumonia is the main focus of rapid assessment of the safety and efficacy of Reeds treatment as a potential therapeutic tool for COVID-19. This series of complementary studies will help us get more extensive data in a short time. Merdad parsey, Gileads chief medical officer for science.
The novel coronavirus Reeds clinical development rate reflects the urgent need for treatment and the joint commitment of industry, government, global health organization and healthcare providers to respond to this public health threat in the most urgent way, he also pointed out.
Readcivir is a drug in development that has not been licensed or approved anywhere in the world, nor has it been shown to be safe and effective. Gilead is working with government agencies, non-governmental organizations and local regulatory authorities to provide readcivir to eligible new coronavirus infected patients, and to provide emergency treatment in the form of sympathetic medication in addition to ongoing clinical research.
It is reported that radcivir is a nucleotide analogue under study, which has broad-spectrum antiviral activity. In vitro and in vivo animal models can fight against a variety of emerging virus pathogens, including Ebola virus, Marburg virus, Middle East respiratory syndrome and SARS virus. Gillid had previously conducted a study of the drug in healthy volunteers and people infected with the Ebola virus. The company stressed that individual cases of sympathizing drug use are not enough to determine the safety and effectiveness of ridcivir in the treatment of new coronavirus, which can only be determined through prospective clinical trials.
According to CNN, Bruce Aylward, assistant director-general of the World Health Organization (who), who reviewed the situation in China on February 24, said: we think there is only one drug that may have a real effect at present, that is, readcivir.