Gilead has started the clinical studies, following the US Food and Drug Administration (FDA) acceptance of its investigational new drug (IND) application for remdesivir
The Centres for Disease Control and Prevention (CDC) illustration of coronaviruses. (Credit: CDC/ Alissa Eckert, MS; Dan Higgins, MAM/Wikipedia.)
US-based biotechnology firm Gilead Sciences has initiated two Phase 3 clinical trials to evaluate the safety and efficacy of remdesivir in adults diagnosed with the novel coronavirus (COVID-19).
The randomised, open-label, multicentre clinical trials will enrol approximately 1,000 subjects at medical centres across Asian countries initially, followed by other countries across the world, by March 2020.
Gilead said that it has started the clinical studies, following the US Food and Drug Administration (FDA) rapid review, and acceptance of its investigational new drug (IND) application for remdesivir.
Also, the studies would expand the ongoing research on the drug, including clinical trial at China-Japan Friendship Hospital, and a US study at the national institute of allergy and infectious diseases (NIAID).
Gilead’s clinical studies to evaluate two dosing durations of remdesivir
Gilead said that its new clinical studies will evaluate two dosing durations of remdesivir, administered intravenously, and the primary endpoint of both studies is the clinical improvement in COVID-19.
The first study is designed to randomise approximately 400 patients with severe clinical manifestations of COVID-19 to receive either five or 10 days of remdesivir.
The second study will randomise approximately 600 patients with moderate clinical manifestations of disease to receive five or 10 days of remdesivir or standard of care alone.
Gilead claimed that it is working with government agencies, non-governmental organisations and local regulatory authorities, and providing remdesivir to qualified patients with COVID-19 on a compassionate use basis for emergency treatment outside of ongoing clinical studies.
Gilead Sciences chief medical officer Merdad Parsey said: “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.”