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FDA OKs 2 phase-3 clinical trials for Gilead's Remdesivir
  • By Shim Hyun-tai
  • Published 2020.02.27 16:08
  • Updated 2020.02.27 16:08
  • comments 0

Gilead Sciences said Wednesday that it has begun two phase-3 clinical trials of antiviral Remdesivir on the novel coronavirus patients.

The randomized, open-label, multicenter clinical trials will initially recruit about 1,000 COVID-19 patients from medical institutions in Asian and other countries with a high number of confirmed cases, starting in March.

The study evaluates different dosing period of intravenous administration of Remdesivir. The clinical trials follow the U.S. Food and Drug Administration's quick review and approval of Gilead Sciences' investigational new drug (IND) application for Remdesivir to treat COVID-19 patients.

These clinical trials are expected to expand ongoing Remdesivir researches conducted by the U.S. National Institute of Allergy and Infectious Disease (NIAID) and the two clinical trials carried out by China-Japan Friendship Hospital in Hubei Province, China. Gilead Sciences has been donating drugs and scientific input for each clinical trial, and the result will be published in mid-April.

"Gilead Sciences is focusing on confirming the efficacy and safety of Remdesivir as a potential treatment of COVID-19, and the clinical trials may enable us to collect a broader range of global data of Remdesivir profile in a short time," Gilead Sciences' Chief Medical Officer Merdad Parsey said.

Parsey added that the swift decision on the clinical development of Remdesivir as a treatment option for COVID-19 pointed to an emerging need for its available treatment in the current situation. Also, the commitment by global pharmaceutical companies, governments, global health organizations and public healthcare providers to respond to COVID-19 helped Remdesivir to be developed as a potential treatment.

In the first clinical trial, Gilead Sciences will assess its safety and efficacy by randomly assigning severe 400 coronavirus patients into two groups, who will take Remdesivier 200 mg for five days and 10 days, respectively. The other study will randomly separate 600 moderate patients to take five days or 10 days of Remdesivir or standard treatment. The purpose of these clinical trials is to assess the efficacy of Remdesivir through normalizing fever and oxygen saturation levels.


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