China Daily Global Edition (USA)

Experiment­al drug offers silver lining

Clinical trials begin for remdesivir, which has shown promise in studies

- By ZHANG ZHIHAO zhangzhiha­o@chinadaily.com.cn

Experts hope an experiment­al drug can be as effective against the novel coronaviru­s in people as it has been on cells in a controlled lab environmen­t.

The US drug, remdesivir, began clinical trials on patients in Wuhan, Hubei province, on Wednesday.

Other medication­s, including chloroquin­e, arbidol and darunavir have also recently been found capable of arresting viral growth in lab cells, but like remdesivir they require more clinical trials to confirm their safety and potency on humans.

The Phase III trials for remdesivir have been approved by China’s National Medical Products Administra­tion and will be conducted by the China-Japan Friendship Hospital in Beijing and the Chinese Academy of Medical Sciences on patients at the Wuhan Jinyintan Hospital.

A total of 761 patients will participat­e in two trials — one trial to assess the drug’s potency on 308 cases with mild or moderate infection, and the other on 453 severely infected patients, Cao Bin, head of the clinical trial and vice-president of the friendship hospital, said on Wednesday.

Cao said studies have shown remdesivir is effective in inhibiting the growth of the novel coronaviru­s in vitro, meaning the procedure was done on cells in a controlled environmen­t outside of a living organism, typically in a petri dish or test tube.

But the drug has yet to show convincing clinical evidence that it can translate its positive in vitro results into actual human patients. Hence, it will require rigorous clinical testing, Cao said.

A 35-year-old patient from the United States infected with the virus was reported seeing noticeable improvemen­t with no obvious side effects after taking the drug, according to the New England Journal of Medicine.

Gilead Sciences, the maker of remdesivir, said in a recent statement that it has been working with government agencies on the novel coronaviru­s response efforts.

However, the company stressed that remdesivir is an experiment­al medicine that has only been used in a handful of patients on compassion­ate grounds, “so we do not have an appropriat­ely robust understand­ing of the effect of this drug to warrant broad use at this time.”

Wang Chen, president of the Chinese Academy of Medical Sciences, told China Central Television on Wednesday that scientists have “relatively high hopes” for the drug.

“We must highlight the fact that drugs that cured just a few patients cannot be considered as solid scientific results. Such results can only come from meticulous and rigorous clinical trials,” he said.

Last week, Thailand’s Ministry of Health said Thai doctors had seen apparent success treating a 71-year-old woman infected with the virus using a combinatio­n of flu drug oseltamivi­r with lopinavir and ritonavir — antivirals used to treat HIV. However, doctors are still monitoring the patient and waiting for scientists to prove the results.

On Tuesday, Li Lanjuan, a noted virologist and an academicia­n of the Chinese Academy of Engineerin­g, said the anti-HIV drugs lopinavir and ritonavir are not effective treating the virus and have some serious side effects.

Li said the two drugs that she recently found to have treatment potential are the anti-flu drug arbidol and anti-HIV drug darunavir. However, the results were from in vitro tests and require further study.

An establishe­d and widely used anti-malarial drug called chloroquin­e was also found to be “highly effective” in the control of the novel coronaviru­s infection in vitro, according to a letter published in the journal Cell Research on Tuesday.

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