US biopharmaceutical company Gilead Sciences is widening clinical trials of remdesivir, its antiviral drug for the treatment of Covid-19, across Asia and several other countries around the world amid the rising number of novel coronavirus cases outside mainland China.
Two new clinical studies, involving around 1,000 patients, will start next month at medical centres in Asia, as well as other countries globally with high numbers of diagnosed cases, according to a Gilead announcement on Wednesday. The studies will assess two dosing durations of remdesivir – administered intravenously.
Gilead is now “in discussions with hospitals in Singapore, Hong Kong, South Korea, Taiwan and [mainland] China” for the expanded trials, a company representative said – without elaborating – in an emailed response to a South China Morning Post inquiry. Results of these studies “may be available as early as May”, the representative said.
The company’s latest initiative will nearly match the number of patients covered by its two trials in Wuhan, capital of central China’s Hubei province and epicentre of the coronavirus outbreak, as well as its recently announced study in the US led by the National Institute of Allergy and Infectious Diseases. Gilead has donated drugs and provided scientific input for these studies, which cover a combined 1,155 patients. The results of the mainland China trials are expected in April.
The accelerated pace and scope of Gilead’s remdesivir clinical studies reflect the pressing need for Covid-19 treatment options amid the continued spread of the coronavirus. The number of diagnosed cases have surpassed 82,000 in more than 40 countries, with more than 2,800 deaths.
While South Korea, Italy and Iran have recently seen a jump in coronavirus cases, mainland China still accounts for the most number of infections and fatalities.
Remdesivir is not yet licensed or approved anywhere globally, and has not been demonstrated to be safe or effective for any use. At present, there are no drugs approved for the treatment of illnesses caused by coronaviruses.
Still, that has not stopped Gilead from providing remdesivir “to qualified patients on a compassionate use basis” – through government agencies, non-governmental organisations and regulatory authorities – for emergency treatment outside ongoing clinical studies, according to the company.
“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,” said Merdad Parsey, the company’s chief medical officer.
Chinese trials for Gilead’s antiviral drug to treat coronavirus still far from reaching patient recruitment goals
The new Gilead trials will evaluate two dosing durations of remdesivir. One study will cover about 400 patients with severe clinical manifestations of Covid-19, who will receive either five or 10 days of treatment with the drug. The second study will involve about 600 patients with moderate clinical manifestations of the disease, who will either receive five or 10 days of treatment with remdesivir, “or standard of care alone”, according to the company, without specifying how this test will be divided.
China began tests for remdesivir early this month, after an infected US patient showed signs of improvement from treatment with the experimental drug, which was initially developed to fight the Ebola virus. Another patient in France also recovered after having been treated with the drug, according to reports.
The clinical studies of remdesivir at 10 hospitals in Wuhan, however, have managed to recruit around 230 patients, which is short of the 761 enrolment target.
“Because the situation with Covid-19 is evolving rapidly, it is difficult to predict enrolment [numbers],” the Gilead representative said. “We believe the [expanded] clinical trials will allow investigators to capture the right profile of patients to get access to remdesivir.”
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This article Coronavirus: Gilead to widen testing of antiviral drug in Hong Kong, South Korea, other Asian markets first appeared on South China Morning Post