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Gilead Starts Two Phase III Trials of Remdesivir for COVID-19
Gilead Sciences (NSDQ: GILD) has started two Phase III clinical trials of remdesivir in adults diagnosed with COVID-19. These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers primarily in Asian countries, although centers in other countries with high numbers of diagnosed cases will also be opened. One study will randomize 400 patients with severe cases of COVID-19 to receive either five or 10 days of remdesivir. The second trial will randomize 600 patients with moderate disease to receive five or 10 days of remdesivir or standard of care alone. A China trial of remdesivir has already started at the China-Japan Friendship Hospital in Hubei province.
The US National Institute of Allergy and Infectious Diseases (NIAID) has also started a US trial of the candidate. Gilead has donated supplies of the drug and scientific input to both studies.
Gilead describes remdesivir as an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens including Ebola, Marburg, MERS and SARS. It was found to be less effective against Ebola than other treatments, but it is expected to be more effective than other nucleotides for COVID-19. Gilead said that individual compassionate use cases are not sufficient to determine the safety and efficacy of remdesivir in treating COVID-19, which can only be determined through prospective clinical trials.
“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. The speed with which remdesivir has moved into clinical development for this coronavirus reflects the pressing need for treatment options and the shared commitment of industry, governments, global health organizations and healthcare providers to respond to this public health threat with the highest urgency,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
The primary endpoint of the Gilead studies is to measure the normalization of fever and oxygen saturation [T < 36.6 C armpit, < 37.2 C oral, < 37.8 C rectal; and Sp02 > 94%, sustained for at least 24 hours through Day 14].
See our other articles on Gilead.