Amidst the current public health emergency, Gilead Sciences has initiated clinical trials for the antiviral agent remdesivir to asses safety and effectiveness against COVID-19.
Remdesivir is an antiviral agent that works by preventing the replication of the virus within host cells. Remdesivir is not yet approved for use in patients, however, has had promising results in pre-clinical animal studies when tested as a treatment for MERS and SARS.
According to Gilead, the drug is still an experimental treatment that has not yet been tested extensively enough to support its widespread use in treating COVID-19. However, based on the results of these early studies, and given the current global spread of COVID-19, Gilead Sciences has begun testing of its experimental drug, remdesivir, in phase 3 clinical trials.
According to Bruce Aylward, assistant director-general of the World Health Organization, “there is only one drug right now that we think may have real efficacy and that’s remdesivir.”
Remdesivir clinical trials
Gilead is currently conducting two Phase 3 clinical trials that are assessing the safety and effectiveness of remdesivir in adults who have been diagnosed with COVID-19. The trials aim to enroll a total of one thousand patients globally. There are two treatment regimens that are being tested in these trials – consisting of 5-day or 10-day dosing regimens of remdesivir. The two trials will investigate the safety and effectiveness of these two regimens on either severe cases of COVID-19 or moderate cases of COVID-19.
In addition to these two trials that have been initiated, Gilead has provided remdesivir for two other trials are being conducted by the China-Japan Friendship Hospital, taking place at multiple healthcare facilities in Hubei, China. These clinical trials in China began enrolling patients in early February, and are expected to have results by April.
Gilead is also providing remdesivir for a phase 2 clinical trial being conducted by the NIH, investigating the potential for remdesivir to treat patients who have been hospitalized with COVID-19.
In addition to supplying remdesivir for these clinical trials, Gilead is coordinating with governments and regulatory authorities to provide remdesivir for compassionate use based on emergency requirements.
In response to the current global crisis, Gilead is working to significantly increase the supply of the drug, coordinating with additional manufacturing partners in an effort to increase production, and creating stockpiles for use in the case of a pandemic.
“Gilead’s primary focus is on rapidly determining the safety and efficacy of remdesivir as a potential treatment for COVID-19, and this complementary array of studies helps to give us a more expansive breadth of data globally on the drug’s profile in a short amount of time.” Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
Gilead – COVID-19
Gilead – Press release:
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