The Ministry of Food and Drug Safety said it has approved Gilead Sciences’ plan to conduct phase-3 clinical trials on remdesivir, an antiviral drug candidate for the treatment of patients infected with the new coronavirus (COVID-19). The green light is expected to prompt hospitals to recruit local patients soon.
The regulator granted approval for Gilead’s two phase-3 studies on remdesivir on Monday.
The randomized, phase-3 trials will evaluate the safety and the antiviral activity of remdesivir (GS-5734) in severe and moderate COVID-19 patients. The studies will take place at the Seoul Medical Center, the National Medical Center, and Kyungpook National University Hospital.
The trials will be part of Gilead’s plan to develop remdesivir as a treatment against COVID-19 infection. Under the oversight of the U.S. Food and Drug Administration, the trials will recruit about 1,000 patients, mostly in Asia where a majority of outbreaks occurred from March, the company said.
According to the food and drug safety ministry’s public disclosure of the information on trials, 75 local patients with severe symptoms (out of 400 in total globally) and 120 with mild symptoms (out of 600 in total globally) will participate in the trials. The number of Korean COVID-19 patients account for about 20 percent of the total participants around the world.
The trial on severe patients will be randomized into two groups – one group with a five-day remdesivir dosing and the other with a 10-day remdesivir dosing.
The primary endpoint will be the percentage of patients whose fever and oxygen saturation are normalized in each group by 14 days. The criteria for normalization of fever and oxygen saturation are when the armpit, oral and rectal temperatures are below 36.6, 37.2, and 37.8 degrees, and when peripheral capillary oxygen saturation (SpO2), an estimate of the amount of oxygen in the blood, is higher than 94 percent.
The secondary endpoint will be the percentage of patients who discontinue testing due to adverse events occurring after the drug administration.
The study on patients with mild or moderate symptoms will randomly divide the participants into three groups – one with a five-day remdesivir treatment, the second with a 10-day remdesivir, and the third with the standard therapy. The primary endpoint will be the percentage of patients who get discharged by 14 days, and the secondary endpoint will be the percentage of patients who discontinue the study due to adverse events after the treatment.
In the two trials, participants will receive a 200mg dose of the drug on day one, followed by a 100mg dose every day until day five or ten. The trials will begin in March and end in December.
An official at Gilead Sciences Korea said, “We are preparing for the domestic supply of remdesivir so that we can immediately start the trials once hospitals complete the procedure of the International Review Boards (IRB) and allocation of patients.”
Gilead had initially worked on remdesivir as a treatment for the Ebola virus. The drug was positive in both in vitro and in vivo activity in animal models against SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome) coronaviruses. Earlier this year, the U.S. used remdesivir to treat the first U.S. case of the new coronavirus for compassionate use.
The U.S. patient showed clinical improvement in just one day, which drew the world’s attention. Since then, the Chinese and the U.S. health authorities quickly approved Gilead to conduct phase-3 trials on remdesivir.
On Feb. 26, Gilead said it would begin testing remdesivir in adult COVID-19 patients in global phase-3 trials, signaling that the agent will be developed as COVID-19 treatment, instead of the Evola virus drug.
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