Taipei American drug maker Gilead Sciences is expanding clinical trials of its investigational antiviral drug, remdesivir, for the treatment of the novel coronavirus (COVID 19) into several Asian countries outside China, including Taiwan, in March, according to a statement issued by the biotechnology company.
From March, the trials assessing remdesivir in 1,000 hospitalized COVID 19 patients will mainly be conducted at medical centers in Asian countries impacted by the coronavirus outbreak, including Taiwan, according to the statement.
The studies will assess two dosing durations of remdesivir, administered intravenously.
One of the trials will enroll randomly approximately 400 patients with severe clinical manifestations of COVID 19 to receive either five or 10 days of remdesivir, while the second trial will involve about 600 patients with moderate clinical manifestations, who will receive five or 10 days of remdesivir or standard care, according to the statement.
Taiwan had wanted to bring in the antiviral drug for the treatment of COVID 19 patients by submitting the request for compassionate use, an option that allows the use of an unapproved drug or medical device for treatment outside of clinical trials, Chang Shan chwen (???), executive vice president of National Taiwan University, who also serves in the Central Epidemic Command Center (CECC), told CNA Thursday.
However, the request has not yet been approved due to the strict restrictions on exports of such unauthorized medicine by the U.S. Food and Drug Administration (FDA), Chang said.
Currently, only a small quantity of the experimental antiviral drug is available for patients participating in the clinical trials to evaluate its safety and efficacy, Chang noted, adding that Taiwan has obtained Gilead Sciences' approval to start trials in the country along with several other Asian countries.
The American drug maker will sign a contract with each of three hospitals in northern, central and southern Taiwan to conduct the trials, according to Chang.
Taiwan's hospitals are gearing up for the clinical trials which are expected to start in mid March at the earliest, he said.
Remdesivir is the only therapy that has so far shown promise for treating COVID 19.
Source: Focus Taiwan News Channel