With new outbreaks of the novel coronavirus (COVID-19) spiked in Korea with seven deaths as of 2 p.m. on Monday, clinical demand is growing for an effective treatment option to fight the deadly virus.
Whether and when Korean COVID-19 patients will receive Gilead’s experimental antiviral drug, remdesivir, for compassionate use is drawing attention. Compassionate use is the use of a new, unapproved drug to treat a seriously ill patient when no other treatments are available.
Gilead is testing remdesivir to treat the new coronavirus in phase-3 trials in China.
The drugmaker initially developed the agent as the treatment of the Ebola virus but failed to prove its effect inside the body. However, the investigational drug recently emerged as the most promising treatment to fight the COVID-19 infection.
The U.S. health officials used remdesivir to treat the first U.S. case of the new coronavirus, and the patient showed clinical improvement in just one day, which drew the world’s attention.
Since then, Gilead is supporting remdesivir not only for Chinese patients but for a phase-3 study to win the indication for COVID-19.
According to ClinicalTrials.gov, a clinical trial opened for 452 hospitalized adult patients with severe COVID-19 symptoms on Feb. 6. The study’s primary completion date is April 3, which signals that the drug’s effectiveness will be evaluated within April.
Another phase-3 study is also registered for 308 patients with mild and moderate symptoms, and the result is likely to come out in April, too.
Among all the drug candidates for COVID-19, remdesivir is likely to get the fastest evaluation.
Gilead said it could provide remdesivir for compassionate use, if it receives requests from the healthcare authorities and researchers, on the condition that the company gets to review the matter. However, as remdesivir is still an investigational drug, the supply could be limited, and the company will make the final decision for supply, Gilead said.
“If we receive requests from the Korean government or researchers, we will consult with the headquarters and try to cooperate as much as possible,” an official at Gilead Sciences Korea said.
Industry watchers are paying attention to when local patients will get access to remdesivir for compassionate use.
Before the local transmissions of the new coronavirus, a small number of patients with the virus infection had mild symptoms. It was sufficient to use Kaletra, a combination HIV drug of lopinavir plus ritonavir, to treat them.
However, after new patients surged and deaths kept climbing, the demand for effective treatments against COVID-19 has also increased.
On Thursday, the COVID-19 Central Clinical Task Force, composed of physicians and experts treating the confirmed patients across the nation, lifted its authority level to “Infectious Disease Central Clinical Committee.”
The committee said as the new coronavirus infiltrated local communities, the clinical need for a new treatment against the virus and diagnostic agent will increase.
Oh Myoung-don, a Seoul National University Hospital physician who leads the clinical committee, said Korea should aggressively develop vaccines and treatments, simultaneously with the disease control, just like the U.S. and the U.K. did.
He called for the state-supported science and technology responses to the outbreak, hinting that clinical trials tied to COVID-19 could increase in Korea in the new future.
An official at Gilead Sciences Korea said, “We are discussing with the Ministry of Food and Drug Safety for local clinical trials on remdesivir.”
<© Korea Biomedical Review, All rights reserved.>